Agenda item: 9.2, Public Board Meeting Date: 26 July 2017

Transcription

1 Agenda item: 9.2, Public Board Meeting Date: 26 July 2017 Title: Prepared by: National Institute of Healthcare Research (NIHR) Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans Helen Quinn, Chief Operating Officer NIHR CRN: SWP Presented by: Helen Quinn Chief Operating Officer NIHR CRN: SWP Responsible Executive: Summary: Actions required: Status (*): History: Link to strategy/ Assurance framework: Adrian Harris, Executive Medical Director The RD&E Board as contract holder for the NIHR Clinical Research Network: South West Peninsula is required to review the annual plan, finance plans and annual report for the network after this has been agreed by the Partnership Group (formed with executive level membership from the SW Peninsula NHS Trusts and other NHS providers). This paper outlines the proposed plans and reports including the rationale for determining finance allocations. The Board is asked to: consider the proposed annual plan and annual finance plans for the CRN: SWP for and the annual report for which have been agreed by the Partnership Group and if in agreement approve these documents. Decision Approval Discussion Information X The NIHR CRN: SWP became operationally live on the 1 st of April 2014; the Board previously discussed and approved the annual plan and finance plans for in March 2014, the annual report for and annual plan and finance plan for in July 2015 and the annual report for and annual plan and finance plan for in July The Royal Devon and Exeter NHS Foundation Trust is the Host organisation for the National Institute for Health Research Clinical Research Network: South West Peninsula and as such provide the governance infrastructure to manage the NIHR CRN: SWP DH contract. Monitoring Information Care Quality Commission Standards Outcomes Monitor Service Development Strategy Local Delivery Plan Assurance Framework Equality, diversity, human rights implications assessed Other (please specify) Please specify CQC standard numbers and tick other boxes as appropriate Finance Performance Management Business Planning Complaints Page 1 of 6 NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans July 2017

2 1. Purpose of paper The purpose of this paper is to provide information to the Board in its role as Host of the Clinical Research Network: South West Peninsula on the annual plan and funding allocations proposed to support the delivery of NIHR portfolio studies by NHS providers across the SW Peninsula area for and also the annual report for Background As Host for the Clinical Research Network: South West Peninsula it is a requirement of the DH contract that the RD&E Host Board approve the networks annual business and finance plans and the annual report. The annual report for and the annual plan and finance plan for have been reviewed and approved by the CRN: SWP Partnership Group whose membership is the CEOs or nominated Executive level deputies of NHS providers across the region. Annual Report The national coordinating centre requires an annual report to be produced on a template format and this document can be found at appendix A. The initial section of the report highlights the key achievements. Annual Plan The national coordinating centre requires the annual plan to be produced on a template format and this document is attached as appendix B. Network performance is measured against seven high level objectives set by the national coordinating centre as well as specialty level objectives set by the national leads for each specialty area. Plans outlining actions supportive of national strategies are also required. Finance Plans Delivery funding is allocated to the 15 Local Clinical Research Networks (LCRNs) from the NIHR Clinical Research Network national Co-ordinating Centre (CRN CC) to support activities described in the LCRN contract which includes the Performance and Operating Framework (POF). The allocation to the CRN SWP for is 10,513,599. Whilst activity forms an element of the delivery funding model, LCRN budgets are not derived by means of a pass through model. LCRNs are awarded a proportion of a fixed allocation; it is therefore possible for activity to increase with no corresponding increase in allocation if activity in other LCRNs is proportionally higher. The allocation to CRN SWP is a decrease on despite a 5% increase in activity. In an additional 6m was available nationally to reward performance this has been withdrawn for , with the loss of this funding and the reduction in the delivery budget the reduction to the region is 5% (8 other LCRNs also had a decrease). Funding is allocated to support all activities outlined in the POF. To date narrative on the principles for the national funding formula have not been released; this has been requested by CRN SWP. Nationally the model is predicated on what has happened previously using recruitment activity only as the surrogate for predicting future activity and funding requirement. No national contingency is held and LCRNs are expected to achieve POF objectives within their fixed allocation. This includes funding the Host function; Core Leadership team; Research Management and Governance; clinical sessions and other service support costs; Patient and Public Involvement and Engagement; Training and Education and Continuous Improvement in research delivery. Page 2 of 6 NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans July 2017

3 3. Analysis Annual report The full annual report is available at appendix A. Performance in relation to the high level objectives was as follows: HLO 1 (recruitment): The local recruitment goal was 22505, was achieved; this performance put the network as 10/15 adjusted for population. HLO 2 (recruitment to target within agreed time): Commercial time to target was only 67% (2/3) against a goal of 80%, given the low number of studies led from the region this metric does not provide the detail about improvement in performance which at a site level was 69%, 75% excluding primary care and an improvement from 55% in HLO 3 (commercial studies): Commercial recruitment rose by 6% on , primary care accounted for 34% of activity. CRN: SWP was 4/15 adjusted for population in relation to recruitment. HLO 4 (time to issue NHS approval to open study): Responsibility for this activity passed from the research network to the Health Research Authority in and for much of the year it was not possible to measure performance. Data at year end was 78% although to note this only represented nine studies. HLO 5 (recruitment of first patients within 30 days): Because of the reallocation of responsibility for opening NHS sites from the network to the Health Research Authority in it was not possible to measure this metric accurately in ; site level data showed 60% for commercial and 67% for non-commercial sites. HLO 6 a (% of NHS trusts recruiting to NIHR studies): Achieved 100%. HLO 6 b (% of trusts recruiting to commercial studies): Achieved 82% against a goal of 70%. HLO 6 c (% of GP practices recruiting to NIHR studies): Achieved 53% against a goal of 40%. HLO 7 (recruitment to DeNDRoN studies): Achieved 1366 against a target of 750. The report was approved by the Partnership Group and has now been reviewed by the national coordinating centre and feedback is at appendix C. Annual Plan The plan was developed, reviewed and amended with Partner Organisation including R&D Managers and Lead Research Nurses/Practitioners, the network Clinical Research Specialty Leads with other clinicians as well as members of the network Patient and Public Involvement and Engagement groups. Local targets were set following analysis of open studies in the research portfolio and knowledge of the available pipeline. Other objectives were developed to ensure compliance with the Performance and Operating Framework which forms part of the network contract. The plan was approved by the Partnership Group and has now been reviewed by the national coordinating centre, feedback is at appendix D. Delivery funding local allocation model for In a local funding model review group with membership drawn from across partner organisations was formed to review the model and make recommendations for allocations to the Partnership group. The group met monthly from April 2016 and considered all of the previous guiding principles by means of options appraisals. The principles were reviewed by Page 3 of 6 NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans July 2017

4 the CRN SWP Executive group and a further option to approve a decrease of 12.5% rather than 10% was agreed. The following guiding principles were adopted to determine the allocation: A. Funding follows activity and is used for permitted activities as outlined in the Performance and Operating Framework B. Cap and Collar. I. Funding will be capped at no more than a 2% increase in funding for any organisation. II. 12.5% decrease for the large acute Trust PHNT is applied. PHNT is the most commercially active of the three large acute Trusts based on activity over the past two years a significant decrease in funding (-27%) would have been applied without a cap compared to a significant increase (+37%) if a cap were not applied at RCHT. PHNT have historically been in receipt of the highest amount of historical funding, thus previous capped reductions in line with a reduction in ABF activity, have not reduced the funding to the Trust at a rate which would reflect their current activity in comparison to other organisations. Other decreases to be stratified based on Trust size, no more than 5% for small and 7.5% for medium acute Trusts. C. Consideration is given to the NIHR High Level Objectives (HLO s) as set out in the Performance and Operating Framework. D. Consideration is given to the NIHR Specialty Objectives as set out in the Performance and Operating Framework. E. Partner Organisations in receipt of funds > 50k provide a full annual plan outlining proposed use of funds and the plan the organisation has to achieve contractual requirements. Organisations in receipt of < 50k funding will provide a business case for continued funding. F. Funding top sliced for the following, the level will be reviewed annually by means of a business case for each element: I. Host Function II. LCRN Leadership and Management III. Primary Care Service Support Costs, Research Site Initiative and Clinical Support Team IV. SWASFT V. Mental Health Trusts VI. Regional Genetics Service VII. Other cross cutting contractual obligations G. A contingency will be held; account will be taken of Trust RCF and commercial generation capacity when considering any contingency applications. All applicants must provide explicit assurance that funds will not be used for CIP. H. Incentivisation and recognition of excellence in performance: A team award for opening a study in a new specialty or with a research naïve department/provider and achieving RTT will attract a 1000 award for the team to support Training and Education. Awarded at end Q2 for previous four quarters subject to modelling and actual LCRN overall allocation. I. Collaborations to deliver division four studies have successfully developed over the past two years with partner organisations working together to deliver studies, recruitment activity is attributed to one Trust within the collaboration. To reflect and encourage this new model of working the allocation of resource within division four will be proposed by the division four Clinical Research Leads (CRLs) and Research Delivery Manager (RDM) following consultation with division four Clinical Research Specialty Leads (CRSLs) and partner organisations. J. Funding is necessary and sufficient and that knowledge of the actual requirements to deliver the portfolio are taken in to account Page 4 of 6 NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans July 2017

5 4. Resource/legal/financial/reputation implications Annual Report The annual report provides an important assurance that the NIHR contract is being delivered and that key objectives are achieved. National feedback on the report acknowledges the good performance that has been achieved. Overall the network achieved the majority of the goals set and exceeded in some metrics; these increases in performance were achieved with a 5% decrease in funds. Annual Plan and Finance Plan The RD&E is the Host organisation on behalf of all NHS providers in the SW Peninsula. If funding is not allocated appropriately the consequence is that the ability of partner organisations to support research will be impaired. This will mean there are fewer opportunities for patients to enter studies which might be of benefit to them. As activity is taken in to account in making national funding allocations fewer recruits can also lead to a reduced funding allocation reducing the potential further to support research on an on-going basis. The annual plan was developed with partner organisations, whilst targets are set nationally if actions that will maximise the potential to achieve objectives are not identified there is a risk that the region will not provide as many opportunities as would be beneficial to patients across the region and will miss key goals identified as national priorities. 5. Link to BAF/Key risks Annual Plan It can be seen from analysis of national data that regions with more Chief Investigators(CIs) have the most recruitment, the number of CIs per region ranges from with CRN: SWP having 48; this impacts not only on recruitment but also the ability to attract other funds including both the grant income and Trust RCF. This lack of CI s is likely to result in a year on year reduction in funding as whilst the region delivers multi-centre studies well, there is clear disadvantage in not having CI s in relation to being offered studies and the other infrastructure that is inherent in a CI rich environment. Lack of CIs remains a key concern of the network and whilst the funding of the LCRN cannot be used to increase the number of CIs, the network has highlighted this risk to other partners through the partnership group and to the SW AHSN. Within remit is ensuring sufficient resource is directed to support local CI s deliver their research and ensuring the region remains competitive to both commercial and non-commercial investigators and sponsors. Improving delivery to time and to target is also a key objective, improving this metric will increase performance funding, increase the capacity funds generated from commercial activity and will also give confidence to partners outside of the region that delivery performance is reliable in order to attract further studies to the region. Annual Funding The budget to support clinical research is determined by what has happened previously in relation to recruitment activity. Whilst information is available about open recruiting studies and potential pipeline, actual recruitment activity can deviate markedly as studies may open or close unexpectedly or are delayed by regulatory or other issues outside of the control of the local network. This budget has therefore been calculated taking in to account guiding principles as described in section 3. All allocations are based on the track record of the partner Page 5 of 6 NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans July 2017

6 organisations, activity will be actively monitored and where activity deviates from predicted activity, budget will be re-allocated as required. 6. Proposals Annual report The Board is asked to agree the annual report for 2015/16 appendix A as approved by the Partnership Group and National Coordinating centre. Annual Plan The Board is asked to consider and agree the annual plan for 2016/17 appendix B as approved by the Partnership Group and National Coordinating centre. Annual finance plans The Board is asked to approve the annual finance plan for delivery funding for (ratified by the Partnership Group and approved by the NIHR National Coordinating Centre) tables 1 and table 2. Table 1: Breakdown of pan regional funding 2,871 k k Host 123 Regional Genetics 35 Service Leadership & Management 575 Midwifery Champion 2 Core functions 403 Training and Education 20 Clinical Research Lead / Clinical 317 Non-pay 100 Research Speciality Lead Local Portfolio Management System 78 Contingency 50 Primary Care Service Support Costs / Research Site 453 Medic / Non-medic 60 Initiative / Sessions Fellows Clinical Support Team 487 DRIVE facilitators 85 Primary Care Pharmacy Champion 12 Rater Somerset 20 Vacancy factor -41 National Lead 51 Table 2: Breakdown of Partner Organisation allocations 7,684,000 k k CFT 174 RDE 1,688 DPT 282 SomPar 113 NDDH 350 SWASFT 41 PCH 47 TSDFT 728 PHNT 1,688 TSFT 983 RCHT 1070 YDH 520 Page 6 of 6 NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans July 2017

7 Appendix A Annual Report NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans

8 LCRN Annual Delivery Report 2016/17 Template Version 1.0 / 27 March 2017 Clinical Research Network South West Peninsula Annual Delivery Report 2016/17 Version: DRAFT V0.1 Document date: 11 th May

9 Clinical Research Network South West Peninsula Our wall of Fabulous Stuff Power of patient stories The CRN SWP partnered with Northern Devon Healthcare NHS Trust on a creative way of sharing a young patient s experience of taking part in renal research. Teenager Ryan Fryer from Bideford suggested a comic strip format for his research participation story in support of the NIHR CRN Our stories campaign and to celebrate International Clinical Trials Day Ryan has taken part in a drug clinical research study as part of his hospital treatment for a kidney condition called Nephrotic Syndrome. Simon Denegri, NIHR National Director for Patients and the Public in Research, said: The best ideas for communicating with patients often come from patients themselves. Ryan's comic strip telling of the way he has helped make a difference to clinical research is a perfect example and I am sure it will have an impact on those who read it. This year Somerset Partnership NHS Foundation Trust embarked on its first NIHR portfolio study as sponsor of the Patient-centred practice within physiotherapy? study. This qualitative research study is looking at what matters most to clients with a musculoskeletal problem or neurological condition during their physiotherapy consultations. More patients in Cornwall with neuro-degenerative conditions had the opportunity to take part in clinical research studies in Cornwall Partnership NHS Foundation Trust (CFT) recruited 62 people to Stroke, MS and Parkinson s Disease studies in collaboration with the acute Royal Cornwall Hospitals NHS Trust. CFT also enrolled almost 200 people to dementia research largely conducted in their own homes and the Trust achieved Recruitment to Time and Target for STEPWISE having successfully identified and screened patients with Psychosis or Schizophrenia. HLO1 24,838 research participants recruited into Portfolio studies this year Research impact Torbay & South Devon NHS Foundation Trust ran the cardiology RAPID-CTCA study, allowing the cardiology team the to provide early CTCA for patients randomised to receive this. As a result the service has been able to discharge some patients earlier from the admissions unit with confidence that acute coronary syndrome had been ruled out. This has resulted in shorter bed stays for randomised patients; with quality information being provided early allowing patients the confidence to resume activities without long out-patient waits. This has improved patient experience and improved patient flow reducing costs for the Trust. Jane Owen of Plymouth believes she wouldn t have survived Diabetes if it wasn t for treatment advances informed by clinical research. Having taken part in five research studies Jane says she can manage her health condition better and feels she is giving something back to the NHS which has looked after her so well. Global leader The South West Peninsula Prime Site is proud to be the top global recruiter of all Quintiles Prime Sites in One hundred and twenty nine people were recruited. This included a debut commercial study at the Beacon Medical Group GP practice in Devon who also achieved RTT. Collaboration between Quintiles and Torbay & South Devon NHS Foundation Trust piloted and evaluated innovative use of videos to support recruitment in the STRENGTH study which accelerated the recruitment of 18 patients. Quintiles was also the sponsor of the CRN SWP annual Research Network Forum awards for the above and beyond contribution of individual research professionals for creating participation opportunities, on time and target research delivery; and innovative patient & public involvement. I owe my life to diabetes research Diagnosed with Type 1 Diabetes when she was 11 years old, Jane was not expected to survive beyond 30. She has participated in five clinical research trials since her very first one in January 2011 and received the Nabarro Medal for exceeding 50 years living with diabetes. Jane said: I wouldn t still be here and leading an active life it is wasn t for health research. Education has proven to be effective and has empowered me to manage diabetes. This year Jane shared her research experience in the NIHR CRN Our Stories campaign and as a guest speaker when Head of the NIHR and Department of Health Chief Scientific Officer Prof Chris Whitty visited the CRN SWP. She also reviewed the first edition of INVOLVE, a pilot magazine produced for public supporters of research in the South West and presented a CRN SWP Annual Research Network Forum award.

10 A life changer DASHER was a cardiovascular study - home grown in the South West - sponsored by the Royal Devon & Exeter NHS Foundation Trust and University of Exeter Medical School. It successfully harnessed the research delivery skills of an acute NHS hospital trust, medical academia and GP community practices. We aim to show that an innovative treatment plan to reduce blood pressure quickly in newly-diagnosed patients with moderate-severe hypertension is safe and works well. We are also investigating the causes of treatment-resistance and hope that this will help blood pressure treatment to be tailored to individual patients needs in the future. Dr Andrew Jordan DASHER Principal Investigator & Clinical Research Fellow Exeter healthcare worker Julie Main (pictured) says her life has been positively transformed since she took part herself in a clinical research study into high blood pressure treatment which she was supporting patient recruitment to. As well as pro-actively identifying patients of St Thomas Health Centre who were eligible to take part in the DASHER clinical research study looking at effective treatment of high blood pressure, Health Care Assistant Julie has also discovered first-hand the benefits of taking part in this trial for her own health. Julie, aged 57, said: I cannot tell you how amazing this study has been for me. I have had the most thorough check-up which I would otherwise have not had and since I have received treatment as a participant of the DASHER study my blood pressure is now under control. Before I was treated for hypertension I was weary, irritable and felt uptight. I couldn t quite put my finger on why I felt unwell but it seemed to creep up on me over a period of time. From being on this study myself and supporting the delivery of this study at our GP surgery I have learnt so much about the importance of blood pressure to my health and wellbeing. I genuinely feel like a new person. This really has been a life changing experience. Research impact Cornwall Partnership NHS Foundation Trust ran the dementia VALID study which involved clinicians gaining new skills through innovative Occupational Therapy training developed in Holland. Patients have benefited from access to the innovative therapy not otherwise available through routine care. HLO2 67% of non-commercial & 79% of commercial Portfolio studies recruited to time & target Elena Lilley says taking part in a clinical trial of a new treatment in the South West for her rare kidney condition transformed the quality of her life. When Elena was 19 years old she faced the prospect of complete renal failure. Elena says she hasn t looked back since participation in a clinical research study: When I started the trial my kidney function was only five per cent. After six years of the new treatment the kidney function has improved to 20% which has made a massive difference to my quality of life. I am not connected to a machine anymore. Now a mum to two daughters, Elena works part time as a travel agent: I can live my life. I work and now have my own family. Taking part in this research trial has completely changed my life. I will always be grateful to research it has given me hope and a future and has helped to fuel my positive outlook on life. Elena shared her research experience through the NIHR CRN Our Stories campaign and as a speaker at the Royal Devon & Exeter NHS Foundation Trust research symposium. One millionth person recruited by GP This year 4,774 people have been recruited by South West GP practices to clinical research studies. One hundred and three GP practices contributed to research delivery in this region in through the CRN Research Support Initiative programme. CRN SWP Clinical Research Specialty Lead for primary care Dr Lisa Gibbons said: This achievement is testimony to the hard work and commitment of practice staff and the trust and goodwill from our patients who agree to take part in the research studies as part of their care and treatment. As part of the national CRN celebrations in March 2017 to mark the primary care recruitment of the one millionth person to take part in an NIHR portfolio specialty study, the CRN SWP generated positive coverage about the top recruiting practices in Devon, Cornwall and Somerset.

11 Praise for CRN SWP Clinical Support Team Dr Tim Bray of the Beacon Medical Group practice in Devon speaks highly of the CRN SWP Clinical Support Team saying: They have not only been a source of incredible knowledge around delivering clinical trials, but also have been fantastic colleagues to work with. We feel A life changer extremely grateful for all the support they have given us to build our confidence in delivering clinical research, and could not have developed our research portfolio without their high quality assistance. The CST helped the practice group secure its first large commercial trial guiding through the Site Selection Visit and the Site Initiation Visit to ensure the Beacon Medical Group was prepared and had the right equipment before the first patient was screened. A Devon man with a chronic health condition for which there is no cure has championed taking part in health research because he said there was nothing to lose and so much to gain by doing so. Howard Almond of Dawlish was diagnosed in 2015 with Idiopathic Pulmonary Fibrosis (IPF) which progressively scars the lung and affects breathing. When offered the opportunity to take part in a one year clinical trial evaluating the effectiveness of a specific drug treatment for IPF, Howard said: Why wouldn t you want to participate in this research? How else are we going to get a better understanding of IPF and how to treat it? I don t know whether I am receiving the actual drug being trialled or a placebo but it has been reassuring having the regular clinic appointments and check-ups. Howard added: IPF is a progressive condition which the medical profession cannot reverse but in the meantime I will do everything that I feel I can to maintain quality and longevity of my life. I hope research will improve the experience of people living with IPF in the future. His participation experience was publicised locally as part of the NIHR CRN Our Stories campaign and through national lung charities. Research impact Royal Cornwall Hospitals Trust ran the diabetes TODFU 2 Study. 29 patients were recruited all of whom had diabetic foot wounds which were expected to require months of treatment with the podiatry service. Participation in the study allowed access to a novel therapy at no cost to the Trust or CCG. Over the six month observation period, the wounds of 20 of the 29 patients healed, most within three months. The majority of patients reported good experience with the device easy to manage and with minimal disruption to their daily lives, in contrast to some of the traditional & costly alternatives. Research HLO6 100% Trusts recruited into non-commercial Portfolio studies 82% Trusts recruited into commercial Portfolio studies 63% General Medical Practices recruited into Portfolio studies Research impact Taunton & Somerset NHS Foundation Trust ran the breast cancer HeartSpare II study looking at reducing radiation damage to the heart during radiotherapy. The study led to The Royal College of Radiographers Breast Cancer Consensus Guidelines recommending the heart sparing technique for all appropriate patients. Taunton s involvement in the study prompted this new approach to be adopted locally; they are believed to be the first centre to do so nationally. Awards SW double cancer research surgery award success A specialist research team at the Royal Cornwall Hospitals NHS Trust has won a prestigious national award for Cancer Research Excellence in Surgical Trials (CREST). The surgical breast cancer research team at The Mermaid Centre in Treliske Hospital Truro achieved the CREST award recognition for their impressive recruitment of patients to a broad-ranging number of research studies. Professor Richard Shaw, the NIHR Clinical Research Network National Specialty Lead for Surgical Oncology, said out of the many CREST award nominations, they showed the greatest merit with the impressive recruitment, depth and breadth of the cancer studies portfolio and a clearly evident multi-disciplinary team approach. There was also cause for celebration in the South West when the NIHR Clinical Research Network for Cancer commended the Upper Gastro Intestinal (GI) Oesophago-gastric Cancer team in Plymouth, led by Mr Richard Berrisford. The commendation was in recognition of the leadership, impressive recruitment of patients to research studies, the depth and breadth of the team s research portfolio and the multi-disciplinary team approach. Cornwall GP Dr Nicholas Jacobsen was highly commended for a national award celebrating excellence and innovation in clinical research. The judges for the NIHR award, in partnership with the Royal College of General Practitioners, were impressed that Dr Jacobsen set up from scratch a research ready team at the Petroc Group practice in St Columb Major within 10 months. Between October 2015 and September 2016 the practice conducted six clinical research studies and recruited 90 patient participants, prepared with training and guidance from the local CRN.

12 Three of the 11 research teams shortlisted for the Health Service Journal Clinical Research Impact Award 2016 were from the South West The NIHR CRN sponsored award category applauds the NHS organisation that has gone the extra mile to embed clinical research as core business and harness the outcomes of clinical research to improve services and treatments for its patients. The South West award contenders were the Emergency Department at the RD&E hospital in Exeter; the Devon Dementia Collaboration (Royal Devon & Exeter NHS Foundation Trust & Devon Partnership NHS Trust) and South West Ambulance Service Foundation Trust. TRAILBLAZERS We were the top recruiting CRN in England of patients (599 enrolled) to Injuries & Emergencies specialty research studies in (adjusted for population). The Emergency Department at the Royal Devon & Exeter (Wonford) hospital was highly commended in the HSJ clinical research impact award category RD&E Consultant Emergency Physician Dr Andy Appelboam said: The development and expansion of emergency medicine research would not have been possible without the fantastic support of our local CRN and hospital trust. With this support we have significantly increased the number of participants in both emergency medicine research and in a number of allied specialty studies, therefore benefiting both emergency patients Research firsts and the wider health community. Plymouth Hospitals NHS Trust enrolled the first global patient to a commercial cancer Haematological study. The study is a Phase I/II, First in Human, Dose Escalation Trial of the Bruton s Tyrosine Kinase Inhibitor M7583 in Patients with Relapsed/Refractory B Cell Malignancies and Expansion Cohorts in Patients with Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma (ABC subtype) that have progressed after at least one but not more than three Prior Lines of Therapy. Professor Simon Rule is the PHNT PI. Royal Cornwall Hospital NHS Trust recruited the first global patient to a Phase III breast cancer study KEYNOTE-355. This is a commercial randomised double-blind study of Pembrolizumab (MK-3475) plus Chemotherapy vs Placebo plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer. The Cornwall PI is Dr Duncan Wheatley. Torbay & South Devon NHS Foundation Trust was the first to recruit a patient to an extension study of ARENA (APD ) for patients with moderately to severely active Ulcerative Colitis. This extension study is intended to help determine the long-term safety and tolerability of APD334 in patients with ulcerative colitis who have completed the 12-week phase 2 study, APD The PI in Torbay is Dr Richard Johnston. Northern Devon Healthcare NHS Trust recruited the first patient in the country to an NIHR-funded study using text messaging with the aim of reducing sexually transmitted infections in young people. It was also the first time ever the Northern Devon Healthcare Trust nursing and health adviser team had opened and conducted a clinical research trial and they enrolled the first participant within just four days of the study opening nationally. NDHT Lead Clinical Research Nurse Jen Morrison said: The practical support, training and encouragement provided by the local CRN was invaluable in preparing the team for their debut study. Oak Tree surgery in Cornwall achieved the first global patient recruitment to a cardiovascular commercial study called ORION-3. This is an open label, active comparator extension trial to assess the effect of long term dosing of inclisiran and evolocumab given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C. The PI for this GP practice within the Kernow Clinical Commissioning locality is Dr Rehan Symonds. Plymouth Hospitals NHS Trust recruited the first patient in the country to the PQUIP study. The Perioperative Quality Improvement Programme: Patient Study (PQUIP) is a UK-wide non-commercial epidemiology of surgery collation of detailed outcome data on 70,000 patients at 100 NHS hospitals over the next four years. The Principal Investigator (PI) for Plymouth Hospitals NHS Trust is Dr Gary Minto. This study is within the Anaesthesia, Peri-operative Medicine and Pain Management. Northern Devon Healthcare NHS Trust recruited eight patients within the first week of being the first site in the CRN South West region to open the bladder cancer study DETECT I. This research is investigating whether the test called UroMark can detect bladder cancer in patients who are being investigated for haematuria. UroMark is currently in development stage and early results indicate that it can detect bladder cancer with a high degree of certainty. The test detects changes in the DNA of cells present in urine. The local PI was Mr Eng Ong. Research impact Yeovil District Hospital ran the orthopaedic TRIO study where patients receive their knee replacement follow up appointment at 8 weeks rather than 12. Staff found the earlier follow up to be beneficial to patients and have continued this practice past the end of the trial period. HLO7 1,366 participants took part in DeNDRoN studies this year We were the 2 nd highest recruiter nationally for Stroke, Diabetes & Neurology studies (adjusted for population).

13 LCRN Annual Delivery Report 2016/17 Contents Glossary.. 3 Section 1 Compliance with the Department of Health / LCRN Host Organisation Agreement... 4 Section 2 Executive Summary... 5 Section 3 CRN High Level Objectives.. 8 Section 4 CRN Clinical Research Specialty Objectives. 21 Section 5 LCRN Development and Improvement Objectives 2016/17 54 Section 6 Operating Framework Compliance Indicators 56 Section 7 Host Organisation report on performance against the LCRN Host Performance Indicators.. 62 Section 8 NIHR CRN Priorities 2016/ Section 9 Other local innovation and initiatives Section 10 LCRN Host Organisation Approval.. 71 Appendices Appendices

14 LCRN Annual Delivery Report 2016/17 Glossary CFT CI CI CRL CRN SWP CRSL CPMS CRNCC DeNDRoN DPT DH HLO LCRN LSL MHRA CTA NIHR NDHT PHNT PI PO PPIE PRA RfPB RTT RCHT RDE SSNAP SomPar SWASFT TSDFT TSFT SSL Cornwall Foundation Trust Chief Investigator Continuous Improvement Clinical Research Lead Clinical Research Network South West Peninsula Clinical Research Specialty Lead Central Portfolio Management System Clinical Research Network Coordinating Centre Dementias and Neurodegeneration Devon Partnership Trust Department of Health High Level Objective Local Clinical Research Network Local Specialty Lead Medicines and Healthcare products Regulatory Agency Clinical Trial Authorisation National Institute of Health Research Northern Devon Healthcare NHS Trust Plymouth Hospitals NHS Trust Principal Investigator Partner Organisation Patient and Public Involvement and Engagement Patient Research Ambassador Research for Patient Benefit (NIHR funding stream) Recruitment to Time and to Target Royal Cornwall Hospitals NHS Trust Royal Devon and Exeter NHS Foundation Trust Sentinel Stroke National Audit Programme Somerset Partnership Trust South Western Ambulance NHS Foundation Trust Torbay & South Devon Foundation Trust Taunton & Somerset Foundation Trust Sub Specialty Lead 3

15 LCRN Annual Delivery Report 2016/17 Section 1. Compliance with the Department of Health / LCRN Host Organisation Agreement 1.1. Please confirm that the Host Organisation has delivered the LCRN in full compliance with the DH/LCRN Host Organisation Agreement Terms and Conditions in 2016/17: Yes 1.3. Please confirm that all LCRN Partner organisations operated in full compliance with the CRN Performance and Operating Framework 2016/17 Yes 4

16 LCRN Annual Delivery Report 2016/17 Section 2. Executive Summary Table 2.1. Executive Summary 1. Host Organisation 2. Governance and LCRN Management Arrangements 3. Business Development and Marketing 4. Information and Knowledge 5. Medical The Host Organisation continues to fulfil all contractual obligations and provides consistent and visible leadership to the Senior Network team and also by means of the Partnership Group. All governance groups are configured and convened regularly and governance and management arrangements are supported by appropriate systems and processes defined in standard operating procedures. Partner Organisations submit annual operational and finance plans to support performance management and support and have monthly meetings with locality RDMs, regular financial audit and an annual review with the senior network leadership team. The Peninsula Quintiles Prime Site was the top global recruiter of all Prime Sites in Collaboration between Quintiles, TSDFT and Health and Care videos to pilot and evaluate the use of videos to support recruitment with the STRENGTH study (17108) accelerated the Trusts recruitment to this complex study. 4/15 adjusted for commercial recruitment, 3 rd highest for GP commercial activity. SME med-tech pathway created to support early contact with SMEs enabling regional guidance on funding, local and national processes and support with protocol development, CE and MHRA approvals. LPMS EDGE is used for performance management (e.g. metrics) and performance support (e.g. study KPI page) in all acute and mental health trusts and is being rolled out in primary care. The BIU developed a LPMS/ODP App (migration of data) allowing for greater performance management of studies in real time ; it not only compares data between the two systems but also highlights data errors to support better data quality. Primary Care CRSL has supported development of bespoke IT solutions to support patient identification and pop-ups in general practice supported by CRN SWP IT solutions website. Regional Cancer Maps were developed mapping all active studies and are now available on the CRN SWP Dashboard; the tool is also publicly available. Bespoke disease infographics created for respiratory (asthma and COPD), cardiology (AF and heart failure), dementia, community pharmacy, smoking cessation and autism; supporting study feasibility, set up and delivery. 1/15 adjusted for population for recruitment to Injuries and Emergencies and Anaesthetics studies; 2/15 adjusted for Stroke, Diabetes and Neurology. Royal Cornwall Hospital Trust were awarded the Cancer Research Excellence in Surgical Trials (CREST) award at the NCRI 5

17 LCRN Annual Delivery Report 2016/17 6. Research delivery 7. Stakeholder Engagement and Communicatio ns 8. Workforce Learning and Organisational Development conference in November DeNDRoN recruitment rose from 750 to 1366 a 34% increase in activity supported by Dementia Leads in each county and collaborative models of delivery across acute and mental health providers. PHNT in haematology and RCHT in oncology achieved global firsts; Oak Tree surgery in Cornwall had global first in a cardiovascular study A study support service matrix of responsibilities was developed with CRN WE with clearly defined activities for members of the core CRN and devolved teams. The Early Contact service has supported Chief Investigators and works closely with the RDS, regional CTU s and HEIs. Regular meetings are held between the CTU and the CRN to support study level RTT. A costing and cost attribution SOP has been developed to support our devolved R&D teams with creating more robust processes for confirming cost attribution and signoff of HRA schedule of events. Training on AcoRD has been given to the University of Plymouth and University of Exeter Finance teams and an AcoRD Specialist has been identified in all R&D teams in the region. The CRN SWP have led regional telecons with Wessex/WoE/Thames Valley and South Midlands LCRNs to share good practices on study recommendations and were actively involved in supporting the changes to the national processes and the national study delivery assessment and the study recommendations. The Study Support Service Co-Ordinator regularly participates in the national teleconferences. The delivery of the Study Support Service is currently tracked on a local database and this is now transferring to the LPMS. A local Chief Investigator report allows for early identification of study delivery issues to support RTT. Established regional PPIE working group with all NIHR stakeholders met quarterly. The Patient Experience Questionnaire was completed by 1559 patients, 94% reported they felt valued and 87% would be happy to participate in another study. Patient walk-through s were piloted and evaluated and this important method for learning from patients rolled out across POs Contributed the highest number of patient participation case studies (8) for the NIHR CRN Our Stories campaign including first comic strip version. Generated positive media coverage including three CRN SWP research active organisations being shortlisted for HSJ Clinical Impact award 2016 and primary care contribution to recruitment success when one millionth national milestone achieved. Four CRN SWP funded staff completed the Advanced Leadership Programme The three DRIVE training modules were CPD accredited and delivered to >320 staff to date across the region. The training evaluation shows participants feel more confident in all aspects of supporting study delivery having completed the training package. The Enhancing Clinical Research Practice Module (facilitated by PHNT and the University of Plymouth) was undertaken by ten staff in 2016/17. 6

18 LCRN Annual Delivery Report 2016/17 9. National Contributions COO member of the CRN Funding and Financial Management Steering Group and provided interim COO cover for WoE CRN. Primary Care CRSL is supporting the national IT project for General Practices DCOO has been actively involved in developing improvements to the study support service study set up and specifically the study recommendations; actively contributed to the PPIE patient research experience survey working group and has worked with the CC Continuous Improvement lead as part of a smaller working group to support the improvement and innovation review. IOM member of NIHR Research Delivery Steering Group; active member of NIHR Commercial Operations Group and member of NIHR Business Intelligence Group contributing on data analytics, infographics, disease prevalence/incidence and deprivation data CRN SWP Communications Lead facilitated a media relations workshop for national CRN communications leads and has provided peer support on writing press releases and guidance on how to create patient stories. 7

19 LCRN Annual Delivery Report 2016/17 Section 3. CRN High Level Objectives Table 3.1. HLO performance HLOs 1. Increase the number of participants recruited into NIHR CRN Portfolio studies Measure: Number of participants recruited in a reporting year into NIHR CRN Portfolio studies. CRN National Target: 650,000 LCRN s planned contribution in 2016/17 Goal = Actual = Specific activities/initiatives in 2016/17 Develop collaborations between secondary care based clinicians and GP and other primary care sites and in our newly establish integrated care organisation (TSDFT) to work in hub and spoke models to deliver research, initially identifying networks for dementia, diabetes and cardiovascular. Performance against plan The Clinical Support Team identified areas of interest with all primary care research leads. This information is reviewed annually at practice visits and used to inform robust feasibility and enable targeted collaborations between secondary care based clinicians and their primary care colleagues. This information also enabled regional collaboration and engagement within the respiratory portfolio. The CRSL for primary care now attends the Diabetes Interest Group in Exeter, Mid and East Devon and presents a regular research agenda item. The dementia leads and primary care meeting was rescheduled for Q1 2017/18 following the recent appointment of 3 regional clinical sub-speciality leads (DENDRON). The RDM for primary care is also the link worker for the integrated care organisation (TSDFT) and meets regularly with the R&D director and lead nurse to identify opportunities for cross boundary collaboration. 8

20 LCRN Annual Delivery Report 2016/17 The RDM for primary care has also met with the Symphony project lead and the R&D manager at Yeovil District Hospital and will be working with them in 2017/18 to identify opportunities to support research growth in primary care and cross boundary working. Studies have become more complex, more studies have opened with less recruits per study, greater non-medic PI capacity is required to ensure the appropriate skill mix in this role and to ensure sufficient PI capacity. Work undertaken with Partner Organisations in 2015/16 identified a significant number of projects that could be led by non-medic PI s, agreement has therefore been reached to increase the number of non-medic PIs across the region in 2016/17 supported with mentorship and additional training where required. In consultation with Directors of Nursing set up a non-medic PI buddy system for all nurse specialists and MDT professionals. This will encourage nurse specialists to recruit to studies and embed research into the clinical service aiding recruitment at the point of care. Increasing medical capacity - Joint infrastructure funding for Clinical Research Fellows will be developed with Partner Organisations to increase medical capacity to support and enhance delivery with the anticipation being that two posts will be established across the region. The appointment of two junior doctors to support research growth in one of our POs through a business case on projected growth for commercial research will be shared with all POs to help negotiate similar appointments in other organisations. POs agreed to support an increase of 1 or 5% (whichever higher) there were 47 non-medic PIs in Jan 2016, by the end of the FY there were 91. This work is still ongoing. Progress has been made with increasing the number of CNS s who take on PI role, notably with the Parkinson s Disease Nurse Consultant for Cornwall being PI for a commercial CTIMP. Funding was reserved for three fellows and was awarded to: support Anaesthetics at PHNT and across the region with a contribution to the SWARM fellow. This has supported recruitment of 1027 at PHNT; the fellow also supported work across the region with total recruitment of 2071 for this specialty; Gastroenterology at RDE where the post supported recruitment of 392 patients and Respiratory and Primary Care at RDE and GP sites where the current fellow has been supporting studies in the respiratory department, ED and at two general practices, this way of working as well as 9

21 LCRN Annual Delivery Report 2016/17 supporting delivery has helped foster collaborations across providers and embed a research ethos Complete the follow up activity project to support better workforce planning and capacity assessments to support more robust feasibility and delivery. How to capture follow up activity and then how to use this data was discussed both by the regional funding model review group to ascertain how this might support funding allocations and also the Lead Nurse/Practitioner group to support workforce deployment. In the first instance a snap shot survey was completed and initial regional findings show in follow-up for non-commercial studies were 653 patients in large scale; in observational; 3351 in interventional active treatment and 4165 in interventional non treatment follow-up. For commercial studies there are 540 in observational; 515 in active treatment and 267 in non-active treatment. The findings will be reviewed at the regional lead nurse meeting to review robustness of data. The regional capacity planning tool developed through the DRIVE project is now being used to support managing the follow up activity. 2A. Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time Measure: Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites. CRN National Target: 80% LCRN s planned contribution in 2016/17 Specific activities/initiatives in 2016/17 Performance against plan Goal = 55% CI studies (60% PI studies at site) Activities and initiatives to support HLO2 were for both A & B and are therefore reported under section 2A. Actual = CI= 67% (2/3) (PI = 69% 101/146 all Plan Key actions for improving Time to Target (T2T) - build on the development of the DRIVE training modules from last year ( This year will focus on the In this year 146 studies have closed compared to 153 in 2015/16 and RTT has improved by 18% overall. The improvement at sites excluding primary care is marked with 10

22 LCRN Annual Delivery Report 2016/17 sites PI = 75% 83/110 excluding primary care sites) implementation of the training modules to all delivery staff to support good feasibility, better recruitment planning, open study delivery, and back on track processes to support early identification of problems with clear escalation routes. Revised training modules will be developed for use with PIs and piloted with CRSLs. Also see Section 4 RTT of 75% for 2016/17 compared to 55% for 2015/16 with a similar number of studies closing. This has been achieved with enhanced performance management processes underpinned by training and education and investment in change facilitators embedded in all Trusts and in primary care. In addition to DRIVE, a root cause analysis was established in Q1 for closed studies (in FY). Template devised for RCA outlining reasons why RTT not met; allows for a meaningful narrative on causes of study not met RTT and encouraging reflective practice on learning, actions, sharing of practice and mitigation. Dedicated RTT reports created from Q1-4 to highlight RTT metrics across POs to enable data cleansing and greater understanding of key metrics. Supporting a similar improvement at primary care sites is proving more challenging. The DRIVE programme is being delivered in primary care but at a slower pace due to the number of sites. Network sites are also now attending as many SSVs as possible to support more realistic feasibility. DRIVE has been added to the regional Induction Manual. Facilitator training was rolled out and training has to date been delivered to over 320 research delivery staff in acute and mental health Trusts and in primary care. Additional data was circulated to RDMs highlighting commercial studies, to support delivery. Bespoke modelling of tools continues in line with DRIVE to support delivery. Revised modules for PIs will be developed in 2017/18 following evaluation of the current modules in March

23 LCRN Annual Delivery Report 2016/17 Initial analysis shows staff reported greater confidence in all aspects of study delivery from feasibility to problem solving studies which are off-track. Performance management processes will be enhanced through the Study Support Service national study delivery assessments which will be implemented locally with clearly defined processes focused on working with CTUs/CIs and sponsors to support changes to recruitment strategies where feasible and where required. A pilot involving lay members in study walk-throughs to identify potential barriers or difficulties with study recruitment at an early stage has been conducted - learning will be shared with a view to implementing across acute and mental health Trusts. Approximately 40 early engagement meetings have been held with researchers. All studies that required a national study delivery assessment have been completed. The new study recommendations and NSDA have been completed on five studies to date. The Chief Investigator report which is RAG rated allows the RDM to review study level performance to trigger performance management support meetings with the sponsor/ci/ctu where appropriate. Walk-throughs are where research staff work through protocol requirements for visits with a patient or lay volunteer including the start of the patient s physical journey from arriving at the site. The pilot was completed and a report with recommendations from the feedback was ratified by OMG August 2016 and disseminated to POs. Examples of value from walk-throughs were shared in CRN e-mag (Q1 & Q3) and in the pilot first edition INVOLVE e- magazine for public supporters of research. The PEQ this year has led to useful feedback to support the use of walk throughs in 2017/18 so further evidence of impact will be collected through case studies 2B. Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time Measure: Proportion of non-commercial studies achieving or surpassing their recruitment target during their planned recruitment period. CRN National Target: 80% 12

24 LCRN Annual Delivery Report 2016/17 LCRN s planned contribution in 2016/17 65% CI (58% PI studies at sites) Actual = CI = 79% 15/19 (PI = 72% 146/203) Specific activities/initiatives in 2016/17 See Above Performance against plan Particular progress has been made at study sites for noncommercial studies. In 2015/16 RTT was at 49% (68/140) compared to 72% this year with an increase in the volume of studies closing 203 compared to A. Increase the number of commercial contract studies delivered through the NIHR CRN Measure: Number of new commercial contract studies entering the NIHR CRN Portfolio. CRN National Target: 650 LCRN s planned contribution in 2016/17 Specific activities/initiatives in 2016/17 Performance against plan N/A See Appendix 5. 3B. Increase the number of commercial contract studies delivered through the NIHR CRN Measure: Number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II IV studies. CRN National Target: 75% LCRN s planned contribution in 2016/17 Specific activities/initiatives in 2016/17 Performance against plan N/A See Appendix Reduce the time taken for eligible studies to achieve set up in the NHS Measure: Proportion of eligible studies achieving NHS set up at all sites within 40 calendar days (from Date Site Selected to Date Site Confirmed ). CRN National Target: 80% 13

25 LCRN Annual Delivery Report 2016/17 LCRN s planned contribution in 2016/17 80% Actual = 78% (7/9) Specific activities/initiatives in 2016/17 Further develop the work with the CCGs on agreement of ETCs. A standardised application process was developed in the last financial year and proposed pooled budget recommended as best practice, CRN SWP will continue to negotiate for this in 2016/17. Establish working group with CIs/Local authorities and CCGs to establish processes for the payment of ETCs for public health studies. Provide framework tool for the principles for assessing capacity and capability to POs to ensure they are able to easily integrate into current processes. Progress against plan A revised application form was developed and meetings with CCGs took place to ensure processes were place. Top tips for completing the application forms have been developed for dissemination in 2017/18 to improve the processes for the CCGs. A paper has been prepared proposing a pooled risk arrangement and this is being taken forward by the Host Medical Director to a joint CCG meeting ETC remains a serious risk to study start up with Kernow CCG not approving any ETC in Q4. A workgroup was not established but contact was made with public health departments to get named contacts studies that may require ETCs approval. New Devon CCG have a representative from public health on their panel who contributes to reviews of studies. Public health ETCs remain a serious risk to growing interventional research in this area. A recent HTA study has managed to secure central PHE funding for the ETCs and commitment from one local authority. A framework was provided based on the CRN local assessment of capacity and capability (ACC). This has led to the POs sharing best practices and the development of a regional tool that all organisations have access to. This is being further developed in the next financial year so that when AAC activities have been conducted in an organisation the tool will be shared through the hub for other sites to access. 14

26 LCRN Annual Delivery Report 2016/17 Collect new performance data points within the LPMS to support performance management of study set up and to support the identification of continuous improvement projects Also see appendix 2. Develop a Project funding/study support service conditions of funding SOP to embed the SSS in POs with clearly defined activities that need to be supported through the service. Develop training modules to support implementation of the SSS and support for Chief Investigators to ensure standard service across the region Further develop the early contact service with HEIs, sponsors and researchers and refine the service following a mid-year evaluation Implement the national study delivery assessment for all CI studies and continue to support CIs through the CI study performance report. All organisations are entering HLO4 data points and data quality issues are resolved through running reports from the LPMS. A regional report is produced on the metrics to ensure that the metric is being met, to date the median for HL04 data at a site level is 35 days. Implementation paper completed and responsibility matrix developed for single, multi-centred and commercial studies to ensure responsibilities are clearly defined to avoid duplication of effort and stream line processes. An SOP has been written to support the devolved activities on cost attribution and to support with the completion of the Schedule of Events (SoE) and statement of activities (SoA) for HRA submission.. Training has been given to RDMs on the national study delivery assessment and further training on the new processes was completed by the Study Support Service Coordinator. An evaluation of the service has been completed and there was positive feedback regarding early contact, signposting and promptness of service. Constructive feedback regarding communicating the service offer and will help support improvements for 2017/18 National study delivery assessments are being completed. CRN SWP were actively involved in developing the new study recommendations. Review training requirements for HRA assessment with all POs on quarterly basis to ensure early identification of training requirements to support implementation of the HRA assessment. The HRA was a regular agenda item at the regional R&D Managers meeting and processes for escalation of issues with HRA are in place. The HRA have attended two events in the region to update staff on processes. There is a continued need to support organisations with the completion of the 15

27 LCRN Annual Delivery Report 2016/17 Schedule of Events (SoE) and this is a priority for next year, a recent SOP has been completed to ensure that R&D departments support this activity. Develop and pilot the use a pharmacy tracker with RD&E, one of the POs to disseminate to teams to track progress of studies that require pharmacy support Regional pharmacy meeting has taken place and set up times for HRA assessment were discussed. A tracker has been devised and currently under pilot. 5A. Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies Measure: Proportion of commercial contract studies achieving first participant recruited within 30 days at confirmed Network sites (from Date Site Confirmed to Date First Participant Recruited ) CRN National Target: 80% LCRN s planned contribution in 2016/17 Specific activities/initiatives in 2016/17 Progress against plan 74% Activities and initiatives to support HLO2 were for both A & B and are therefore reported under section 2A. Also see section 8. Key objectives for improvement in the First Patient First Visit metric are included in the implementation of the DRIVE initiative training package and tools to support an improvement in delivery ( Study level data is not available; site level is 60% (18/30). Facilitator training has been rolled out and training is being delivered at all POs supported by DRIVE tools. 5B. Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies Measure: Proportion of non-commercial contract studies achieving first participant recruited within 30 days at confirmed Network sites (from Date Site Confirmed to Date First Participant Recruited ). CRN National Target: 80% LCRN s planned contribution in 2016/17 Specific activities/initiatives in 2016/17 Progress against plan 55% See above Study level data is not available; site level is 67% (71/106). 16

28 LCRN Annual Delivery Report 2016/17 6A. Increase NHS participation in NIHR CRN Portfolio studies Measure: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies CRN National Target: 99% LCRN s planned contribution in 2016/17 100% Actual = 100% (11/11 trusts) Specific activities/initiatives in 2016/17 There are open and recruiting studies at all NHS Trusts and it is therefore expected that 100% of Trusts will recruit in 2016/17. Funding will be provided to all NHS Trusts who are currently research active and continued funding will be provided to non NHS providers to support research activity (e.g. Virgin Healthcare opened their first study in 2015/16). Performance against plan 100% NHS Trusts recruited as well as other NHS providers including Virgin Healthcare and Livewell Southwest. Recruitment was in the NHS Trusts compared to in 2015/16 a 5% increase in activity. 6B. Increase NHS participation in NIHR CRN Portfolio studies Measure: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies CRN National Target: 70% LCRN s planned contribution in 2016/17 73% Actual = 82% (9/11 trusts) Specific activities/initiatives in 2016/17 LCRN to insert from 2016/17 Annual Plan In 2015/16 69% of Trusts had open commercial studies 82% of Trusts were engaged with commercial activity, as CFT and DPT worked with acute providers as one team to deliver dementia studies contracts were held by the acute Trusts which reduced the overall reporting of activity. Collaborative working is a model that will be supported in 2016/17 to ensure all Trusts can engage. There is also an aim to open at least one Mental Health commercial study in at least one of the MH providers in 2016/17. Performance against plan Commercial recruitment was 1898 compared to 1704 in 2015/16 an increase of 10% making the network 4/15 adjusted for commercial recruitment. New commercial studies have been opened in Mental Health with CFT exceeding RTT in DEME3921 Exelon; CFT also opened the Janssen depression intervention study in CFT are currently in set up for a second commercial trial, DEME30373, with MERCK and anticipate this opening Q1 2017/18 (sponsor delay). DPT have also been selected, and are awaiting a start date 17

29 LCRN Annual Delivery Report 2016/17 Also see Life Sciences Plan Appendix 5. for the DEME30373 MERCK dementia trial and under the DDC umbrella have opened the Daybreak study Quintiles/Janssen. Both DPT and CFT have submitted EOIs to Boehringer-Ingelheim for a phase III trial in schizophrenia and are awaiting selection. 6C. Increase NHS participation in NIHR CRN Portfolio studies Measure: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies CRN National Target: 35% LCRN s planned contribution in 2016/17 40% Actual = 53% Specific activities/initiatives in 2016/17 In 2016/17 CRN SWP will continue to run the RSI scheme and also provide a Clinical Support Team to facilitate research delivery in primary care with a view to achieving 40% of practices in the region delivering NIHR recruitment (reduced from 2015/16 as million women study closes). Also see Primary Care in section 8. Performance against plan The RSI scheme was run again in 2016/17 with 41 practices receiving level 1 and 2 funding and 12 sessional practices. Each RSI practice had support from a designated member of the networks Clinical Support Team (CST). During the year 50 affiliated practices also recruited to 24 studies. CST research nurses supported 30 studies at 51 sites and recruited 1294 patients. 7. Increase the number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio Measure: Number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio CRN National Target: 20,000 LCRN s planned contribution in 2016/ Actual = 1366 Specific activities/initiatives in 2016/17 Increase clinical leadership in Dementia research across the region by appointing specialty leads in each county with a spread across Acute and Mental health providers as opposed to one Dementia speciality lead in FY 15/16. Performance against plan Dementia Sub-Specialty Leads were appointed and commenced their NIHR role for all three Counties. This has facilitated the Devon Dementia Collaboration Model being replicated in Somerset and Cornwall. SomPar have a 18

30 LCRN Annual Delivery Report 2016/17 182% of goal and a 34% increase in activity research meeting arranged for the 1st of June and are in the process of setting up an interventional non-commercial study Evaluating the effects of novel GPL1 Analogue, Liraglutide in patients with Alzheimer s (ELAD). Two strategic meetings with the clinical leadership group have now been held, one including Primary Care and Re-Cognition to discuss the regional strategy for delivering HLO7. Ensure a minimum of one DeNDRoN study is open as a collaborative model at the following sites: CFT - RCHT, SDHT - DPT, RD&E - DPT and SomPar - YDH - TSFT. Continue with JDR user webinar training twice per year - ensuring every trust has at least one member of staff trained to utilise the JDR system and extract matched recruits for studies. CFT and RCHT opened PD Safe and successfully recruited 52 against a target of 20. SDHT and DPT opened and recruited to DEME 4398, Radar, AD Genetics and MERCK AD utilising the collaborative model for delivery. SomPar, YDH and TSFT opened PD STAT with TSFT and YDH utilising SomPar staff for cognitive ratings scales. PD Comm is open at 3 sites TSDFT, TSFT and RDEFT. Q1: JDR training provided via two webinars and two face to face sessions. Six attendees trained from Re:Cognition Plymouth and Livewell SW. Q2: JDR training provided via two webinars and one face to face session. Five attendees trained from Re:Cognition, DPT and Primary Care. Q3: JDR training via three webinars. Four attendees trained from RDEFT & TSDFT. Q4: JDR training via two webinars. Four attendees trained from PHNT & SOMPAR. Total number of JDR trained research staff is 44, based at all Trusts where JDR appropriate studies take place. 19

31 LCRN Annual Delivery Report 2016/17 Identify at least one GP hub/practice with a specialist interest in Dementia to collaborate with the Devon Dementia Collaboration and either work as a PIC or partner on a Dementia study. Included in the Primary Care project plan for Primary Care C.V s. Multiple practices expressed interest in supporting the Devon Dementia Collaboration. Practices have displayed posters and leaflets for the VALID study and 6 practices acted as PIC sites for the ASC study. A meeting has been scheduled for Q1 2017/18 following the recent appointment of three regional dementia leads to include all regional primary care and private providers to discuss a strategy and develop a plan to work together. Maximise use of JDR feasibility tools as a possible mechanism of identifying patients in primary care who would be eligible for DeNDRoN portfolio studies. CST provide ongoing support in primary care to maximise opportunities. 3,000 JDR leaflets ordered in year and distributed between primary care (via CST & events) and members of the public. Guidance for ordering free top-up materials shared directly with GP Practices & Memory Cafes directly via e-bulletins and local events. Q1: JDR stand & materials at UoP BRACE event. Q2: One practice ran a JDR month using their TV screens in the waiting room. Q3: 3 Memory Cafe events (Cornwall, Devon & Somerset) organised to engage with Memory Cafe coordinators throughout the SW and specifically target early onset group to match local study focus. 63 attended. Q4: JDR stand at RSI/Primary Care event. CRN SWP Communications actioned six requests from practices for JDR stock to be replenished). Guidance published in CRN SWP e- bulletin for primary care on how to re-order materials. 20

32 LCRN Annual Delivery Report 2016/17 Section 4. CRN Clinical Research Specialty Objectives Table 4.1. Contribution to 2016/17 Clinical Research Specialty Objectives # Specialty Objective Measure Target LCRN actions to achieve objective Performance against plan 1 Ageing Proportion of Ageing-led studies on the NIHR CRN Portfolio which are multicentre studies is maintained at 50% or above 2 Anaesthesia, Perioperative Medicine and Pain Management Establish links with the Royal College of Anaesthetists Specialist Registrar networks to support recruitment into NIHR CRN Portfolio studies Proportion of Ageing-led studies which are multicentre studies Number of LCRNs where Specialist Registrar networks are recruiting into NIHR CRN Portfolio studies 50% The goal is to increase recruiting studies in the SWP from three to five and maintain >50% of studies to be open at multiple sites. 8 (of 15) The established links with the South West Anaesthetics Research Matrix continue to support recruitment in to NIHR Portfolio studies. A Research fellow is funded for one year and led recruitment into the CUPPA study, recruiting at six CRN SWP sites until September, During 2016/17 there were no new Ageing studies to offer PO s. Recruitment continued in the two open studies and Recruitment currently at 23 for 2016/17 Recruitment to CUPPA completed 30/09/2016 at 6/7 CRN SWP sites. All sites recruited to time and target patients in total. The SWARM group were named Anaesthetic team of the year at the 2016 BMJ awards. The first anaesthetic collaborative to win this award. Establish links with the Severn Trainee Anaesthetic Research Network (STAR) to enable YDH to participate in future SWARM studies. CRSL and RDM in contact with the STAR (Southern Trainee Anaesthetic Research) Network chair to ensure that YDH can participate in future SWARM projects. CRSL is happy that the site is linked to a trainee network and is able to participate in current portfolio studies via STAR. 21

33 LCRN Annual Delivery Report 2016/17 In 2016/17, the CRN SWP will support the Research Fellow in post to open a further three Local Chief Investigator studies at CRN SWP sites to include CADET - a complex pre-operative assessment study at PHNT, OPTIMISE 2 - a fluid balance study and a Peri-operative Quality Improvement project of post-operative outcomes. CADET study (Coronary Anatomy and Dynamic Exercise Testing) opened in June 2016 at PHNT. Single centre study with CRSL as Chief Investigator. Recruiting to time and target (223) with closing date Q The PQIP study (Perioperative Quality Improvement Programme) began recruitment in Q3 and is open at five sites, PHNT recruited the first patient nationally and to date 91 patients have been enrolled. 3 Cancer Deliver a portfolio of studies including challenging trials in support of national priorities Number of LCRNs achieving recruitment to NIHR CRN Portfolio studies in 4 challenging areas which is either improved from 2015/16 or exceeds the following national targets: a) Cancer Surgery: 4 recruits per 100,000 population served 15 (of 15) a) Minimum of 88 patients to be recruited into surgical studies. Four surgical studies currently open (IMPACT, RADICALS, CALIBER & UK Genetic Cancer Prostate study) and aim to open a further six surgical studies throughout 2016/17. Studies currently in pipeline include GROINS-V-II, SHAPE, STATEC, Pathos and Beyond TME, additionally local Chief OPTIMISE II study did not submit to HRA in 2016/17. The RDM has been in contact with the CI and the study was link sent to all acute sites for early expressions of interest in September The study is now expected to open Q /8. CRN SWP have 33 open and recruiting studies in the cancer surgical portfolio for 16/17 and have recruited 494 patients to this portfolio. SHAPE opened at 1 SWP site and Groins opened at 2 SWP sites. STATEC, BEYOND TME and 22

34 LCRN Annual Delivery Report 2016/17 b) Radiotherapy: 6 recruits per 100,000 population served c) Rare Cancers (ASR <6): 12 recruits per 100,000 population served d) CYP: 3 children per 100,000 population served,* and all LCRNs to record the number of year olds participating in cancer studies *LCRNs which do not include a PTC to provide evidence of referral pathways to access research Investigator led study TIC-TOC (Gynae- Oncology Surgery) is due to start recruitment in Q3. b) Minimum of 132 patients to be recruited into radiotherapy trials by the end of Q4. 15 radiotherapy studies are currently open in SWP. Our aim is to open a further six radiotherapy trials throughout 2016/17. INTERLACE gynae- oncology trial is currently open at two sites in the SWP and looking to open at a further two sites. Appoint Radiotherapy Sub-Specialty Lead by the end of Q2 to help facilitate objective b and work to unblock access issues for SABR trials. PATHOS did not open, however overall recruitment to surgical trials exceeded target by 561%. Additionally, local CI study TIC TOC opened in Q3 and recruitment commenced in Q4. Royal Cornwall Hospital Trust were awarded the Cancer Research Excellence in Surgical Trials (CREST) award at the NCRI conference in November 2016, The award went to the breast cancer surgical trials team for their collaborative approach and excellent MDT working. Additionally Plymouth Hospitals Trust Upper GI surgical team, were highly commended. CRN SWP have 24 open and recruiting studies in the cancer radiotherapy portfolio and have recruited 196 patients to this portfolio exceeding target. Interlace opened at 3 SWP sites with recruitment occurring at all 3 sites The Division 1 CRL and radiotherapy sub-specialty lead worked to resolve issues across the SWP and TSFT are now able to access SABR and deliver SABR trials. c) Minimum of 264 patients will be recruited CRN SWP has 43 open and 23

35 LCRN Annual Delivery Report 2016/17 into rare cancer trials by the end of Q4. 39 rare cancer studies are currently open in the SWP. Our aim is to open a further ten rare cancer studies throughout 2016/1 recruiting studies in the rare cancer portfolio and have recruited 345 patients to this portfolio exceeding target by 130%. The ISKS study, currently in set up, will open by the end of Q2 aiming to recruit 50 patients a year. Study specific guides to aid recruitment into rare cancer genetics studies will be in place by the end of Q2 to aid clinicians and genetic counsellors in the identification of patients suitable for participation in rare cancer genetic research. ISKS opened at PHNT in Q1, Recruitment commenced in June 16 and current recruitment is 29 for 16/17. 2 Cancer Research Nurses undertook training in the taking of genetic pedigree information from patients and although this was completed in Q1 it took the team longer than anticipated to feel competent and confident. Recruitment is now on track These have been developed by the regional genetics service and are being used by clinicians in satellite clinics across the SWP. The CRN SWP is working towards strategically improving an intra-network referral process supported by all sevens R&D departments in the SWP. This will go some way to helping achieve objective a,b & c and HLO 1. Agreement on this will be finalised by the end of Q1. Workshop facilitated by deputy COO on 8/7/16 to discuss strategy with R&D Managers. The workshop led to specific input to the cancer portfolio maps clarifying the difference between clinical referral and PIC activity. This was followed by a further workshop on collaborative working across specialties which has led to specific actions for specialities 24

36 Develop regional cancer maps to facilitate improved intra network referrals, this will be piloted in the Breast and Haematology portfolio during Q1 and will be extended to all tumour sites by the end of Q4. CRN SWP RDM to work in collaboration with CRN WoE RDM in order to share Oncology / Haematology educational events, symposiums and tumour specific study days. This collaboration will improve communication and encourage further crossnetwork referral helping both Networks to achieve all cancer objectives for 16/17. LCRN Annual Delivery Report 2016/17 e.g. cancer to create collaborative agreements between small and large acute sites; promoting the use of primary care PICs to support dementia and respiratory Regional ETC applications are now being coordinated by the Division 1 RDM where specialist commissioning from NHS England is required. Regional Cancer Maps were developed for all active portfolios and are available on the CRN SWP Dashboard. The tool is publicly available and link has been circulated to MDT leads, SSL s R&D managers and lead research nurses. This tool will be evaluated in 2016/17 to test use of the tool and whether this supports cross referral to other sites. Collaboration with WoE Network is ongoing with a number of study days and networking opportunities shared and attended. Collaboration and communication links remain strong, the RDM for division 1 has been asked to mentor the new West of England RDM for division 1 who come into post in Q1. d) The CRN SWP operates a very effective The shared care arrangement with 25

37 LCRN Annual Delivery Report 2016/17 shared care arrangement with UH Bristol Children s Hospital where children are offered participation into available clinical trials. UH Bristol was reviewed, updated and circulated to all 7 shared care sites across SWP and WoE Network with agreement achieved in Q Children & Young People have been recruited into trials across both Networks, exceeding target 137% RDM to review all TYA diagnosed with Cancer in the SWP from age and determine percentage who entered clinical trials in order to benchmark activity by end of Q2. Once achieved, referral pathways for this group of patients will be defined collaboratively between the paediatric and adult oncologists with improved access to clinical trials by end of Q4. This will be done in collaboration with CRN WoE CRN SWP recruitment to cancer trials in the age range was 7 patients which equals 8% of our estimated incidence. To note there is no children's hospital in the region and shared care arrangements will mean it is likely a number of teenagers in this age range will have been recruited at UH Bristol. Work on the referral pathway is ongoing with the TYA Lead for the South West (which includes SWP and WoE) and both RDM s. This work was delayed slightly due to the time taken completing work on the collaborative agreement, but will be starting with the Germ Cell Cancer pathway in 17/18. 4 Cardiovascular Disease Increase NHS participation in Cardiovascular Disease studies on Number of sites recruiting to Congenital & PAH, Surgery and CV Prevention studies 5% increas e EMMACE4 - ensure six of six sites participate in the follow-on study once released. All 6 SWP sites conducting the EMMACE study achieved recruitment goals. Now awaiting sponsor to progress with the set-up 26

38 LCRN Annual Delivery Report 2016/17 the NIHR CRN Portfolio in challenging and priority areas Identify at least four primary care practices with a specialist interest in cardiovascular to act as a PIC, supporting recruitment specifically for STRENGTH & THEMIS studies. Develop individual study videos in collaboration with Quintiles and TSDFT to promote cardiovascular studies in the region. CRSL is leading on this with Priority given to Quintiles studies STRENGTH & THEMIS which are challenging to recruit to. Support SWP CI device study with Plessey funded by the small business research initiative (SBRI) to roll out to 15 GP practices with a recruitment target of 1500 (device designed to screen for AF). Not all SWP CRN acute Trusts offer services within subspecialties. Surgery PHNT (ETTAA) TSFT (ETTAA) & RCHT (e- Ultimaster) The only cardiovascular of the sub study EMMACE 4. Four practices were set up as PIC sites in Torbay to support the STRENGTH and THEMIS studies. All 3 sites conducting THEMIS have closed green 1 met target, 2 exceeded target. STRENGTH has exceeded target at TSDFT with 18 patients recruited against a target of 10. The healthcare videos have been developed and evaluated in use for the STRENGTH study. The evaluation report will be completed shortly with initial findings showing positive effects on recruitment, staff and patients. Plessey (SME Sponsor) have now appointed a study coordinator during Q3 and changed the original scope of the project. At end of year the study coordinator was still awaiting confirmation of funding for the study from Plessey. The study now plans to recruit 400 pts within out-patient stroke clinics at RD&E. Recruitment to cardiovascular studies totals 874 for 2016/17, with recruitment into every sub specialty and increased recruitment into the 27

39 5 Children Increase NHS participation in Children's studies on the NIHR CRN Portfolio Proportion of NHS Trusts recruiting into Children s studies on the NIHR CRN portfolio surgery site we have in the SWP is PHNT it is therefore only possible to include other sites if the study requires follow up postsurgery which is how TSFT & RCHT gained studies last year. There is not currently a study in the pipeline for FY16/17 which would allow this. 90% Establish a paediatric trainee-led audit and research collaborative (similar to the SWARM group) with the objective of submitting one draft research funding proposal and develop plan for supporting for research delivery Work with CRN West of England Paediatric research teams in order to secure vaccine studies with the objective of increasing our overall recruitment to studies LCRN Annual Delivery Report 2016/17 high importance subspecialties: Cardiac Surgery 81 (23% increase) Cardiovascular Prevention 54 (64 % increase) with an increase in the number of sites from 2 to 3. Congenital Heart Disease 16 (300% increase). The CONNECT event took place in Q3. The objective to raise the profile with paediatric trainees was met and the meeting was used to launch the PenTrain research collaborative. The network is not yet at a level of maturity to have submitted proposals. CRN WE Paediatric teams were invited to the CONNECT event again this year and a number attended. A teleconference was held with RDMs, COOs, CRSLs and WE CD in Q4. Advice was given about further potential general research collaborations which the CRSL will follow up. The region is the only LCRN that does not have a Children s Hospital; this will limit the studies it is possible to engage with. 6 Critical Care Increase intensive Proportion of intensive 80% To increase the number of commercial Two commercial studies were open 28

40 LCRN Annual Delivery Report 2016/17 7 Dementias and neurodegeneration care units participation in NIHR CRN Portfolio studies Optimise the use of Join Dementia Research to support recruitment into Dementia studies on the NIHR CRN Portfolio care units recruiting into studies on the NIHR CRN Portfolio The proportion of people recruited to Dementia studies on the NIHR CRN Portfolio who were identified via Join Dementia Research studies open within the specialty from one to two, by close collaboration between the IOM, CRSL, RDM and industry partners to identify suitable sites to host studies. To formalise the Critical Care Trust leads meeting to occur on a quarterly/bi-annual basis, led by the RDM & CRSL. Identify research champions within the neurology and cardiac intensive care units at PHNT to support opening studies within these areas. 6% To better support SWP Trusts and optimise the use of JDR to support recruitment, there will be a drive to target participants who are diagnosed with Dementia at the point of enrolment to JDR. This targeted approach will be directed to Memory Cafes n=92 in the SWP. According to the AHSN SW report Nov 2015 Mapping of Dementia Services a mean of 17 Dementia patients attend the 92 memory at PHNT the ART 123 trial and CRIT The Clinical Research Specialty lead is working with COMBACTE (Combatting Antibiotic Resistance in Europe) Group to identify studies. A critical care leads contacts list was completed which enabled the first meeting to be held on 12/10/2016. A face to face meeting was then held in Exeter on 01/02/2017 with representation from clinicians and/or research nurses from all CRN SWP acute Trusts. Future meetings will continue with 2 teleconferences and 1 face to face meeting per year. Research nurse identified. No new studies have been opened this year due to lack of pipeline. Current ratio of participants diagnosed with Dementia in the SWP enrolled onto JDR is up 2% from 13% in FY 15/16 to 15% in FY 16/17. Q3 JDR Memory Cafe events in Somerset, Cornwall and Devon were well attended and received. Coordinators deployed to raise awareness and encourage sign up 29

41 LCRN Annual Delivery Report 2016/17 cafes each month. to JDR by people with dementia and their families. Attendance numbers; Somerset 21; Cornwall 22; Devon 20 Enrol JDR Champions in six Memory cafes (two in each county). Provide training, education and access to promotional materials on JDR to these champions. A bespoke newsletter was issued to Memory Cafe leads and attendees in Q4 with an end of year roundup of JDR success in SW. Memory Cafe champions have been confirmed in each County. Further JDR materials and presentation slides/packs distributed. At a National level only 16% of participants recruited to JDR have a diagnosis of Dementia. Current recruitment activity to JDR in the SWP runs at 13% diagnosed with Dementia at the point of recruitment. Aim is to achieve a 16% target of JDR recruitment being Dementia diagnosed in the SWP in order to better support pipeline of Dementia studies as opposed to healthy volunteers trials. As of 31/03/2017 ratio of participants diagnosed with Dementia in the SWP enrolled onto JDR is 15% up from 13% in Q4 FY 15/16. CRN hosted specific events for each county in Q3 to brief and enlist Memory Cafe co-ordinators to increase number of people with dementia and caregivers signing up to JDR. Publicity generated on JDR website, local print media and social media. Also published on Healthwatch sites. Short films with dementia study participants produced by CRN SWP Comms Lead to promote JDR Q3 for 30

42 LCRN Annual Delivery Report 2016/17 Target SWP sites to achieve 15% of Dementia trials recruitment direct from JDR. Link into LCRN PPIE and Communications cross-cutting teams to promote JDR across the network at all opportunities throughout the year. website and talks at events. Recruitment to the DeNDRoN portfolio exceeded the target of 750 with 1366 patients recruited. 652 were recruited into the dementia sub-specialty of which 12% were recruited directly from JDR. This dropped from 14% at Q3 due to dementia recruits identified not using JDR. To note MCI is not a JDR field and this is an impotent part of the DeNDRoN portfolio. Recruits from JDR increased from 39 in FY to 76 during FY Regular updates were sent to all JDR trained staff where relevant to their studies. Staff have been offered updated webinar training on JDR alongside the training of new staff. All trusts participating in the International Clinical Trials Day had a supply of JDR promotional materials. The network had a JDR stand at the University of Exeter Dementia event in Q1. JDR materials were distributed to GP practices Q2. PP slides promoting JDR supplied to practices & partner trusts for clinic info screens Q3. Q3: 3 Memory Cafe events 31

43 LCRN Annual Delivery Report 2016/17 (Cornwall, Devon & Somerset) organised to engage with Memory Cafe coordinators throughout the SW and specifically target early onset group to match local study focus. 63 attended. Q4: JDR stand at RSI/Primary Care event, attendees invited to order top up materials during the day. JDR focused media releases issued in April, August and September Three short films with dementia study participants sharing why they support research was produced by the Communications Lead for the HSJ award shortlisting of Devon Dementia Collaboration and the national JDR website in Q4. JDR regular updates featured in CRN SWP e-magazine and primary care e-bulletin. Magazine feature published in West Devon Moorland magazine and run as guest blogs on Healthwatch websites. Working at the study feasibility and preapproval stage with local Chief/Principal Investigators to promote the use of JDR and assist with target setting and submission of site intelligence. RDM met with local CIs who incorporated JDR in their recruitment strategies. The anticipated overall recruitment is > Dermatology Increase NHS participation in Number of sites recruiting into Dermatology studies 160 Identify all primary care providers with a research lead interested in supporting the Primary care providers were identified. Research Associates have 32

44 LCRN Annual Delivery Report 2016/17 Dermatology studies on the NIHR CRN Portfolio dermatology portfolio. Establish a working group from secondary, primary, and community care including community pharmacists and nursing home providers to develop a strategy for growing and delivering the portfolio. Link with the tissue viability team from Peninsula Community Health to establish the potential for non-medic principal investigators. continued to highlight opportunities for engagement within this portfolio. In 2015/ practices recruited to 1 commercial interventional study, in 2016/ practices recruited to 1 commercial interventional study and practices within New Devon CCG have acted as PIC sites for the ALPHA study. Interested practitioners from primary care, secondary care and non-nhs providers have been identified. A working group has not been convened within year due to limited availability for studies to be placed outside of secondary care. Links were established with the Tissue Viability Nurse Consultant based at Cornwall Partnership Trust. Support and advice was given on potential research opportunities and training. 9 Diabetes Increase participation in studies relating to areas defined to be of national priority for Government agencies and Research Funders A: Number of LCRNs recruiting and/or referring into immunotherapy studies for recent onset T1 diabetes. B: Number of sites participating in studies relating to the prevention of diabetes A. 15 (of 15) B. 5% Support recruitment to recent onset T1 diabetes supporting the seven acute Trusts to continue to recruit to ADDRESS 2. Support the opening of the Chief Investigator TriMaster study at all Peninsula acute sites All acute sites recruited, with 71 patients entered into the ADDRESS 2 study. The study was delayed by sponsor and eventually opened Q4 in 3 acute Trusts (all on target currently). NDHT did not proceed; 33

45 LCRN Annual Delivery Report 2016/17 and its complications. the remaining acute Trusts are in set-up. PIC sites were organised in primary care. recently awarded grant (Clinical Fellowship) for a podiatry study Podiatry study preventing complications of diabetes - Reducing Foot Plantar Pressure (ReFPPres) in people with diabetes using an instant insole solution: a mixed methods feasibility study will be opened in Q3 Develop close regional collaborations (GPs with specialist interests) between GPs and acute Trusts to ensure a broad spectrum of patients can be identified across the clinical pathway The CI is still completing the protocol and the study will now open in 2017/18. RCHT recruited 29 to the TODFU 2 all of whom had diabetic foot wounds which were expected to require months of treatment with the podiatry service. Participation in the study allowed access to a novel therapy at no cost to the Trust or CCG. Over the six month observation period, the wounds of 20 of the 29 patients healed, most within three months. Div 5 RDM has produced document to identify GPs with a special interest in Diabetes; a meeting was held with the Director of non-nhs provider Sentinel to discuss the diabetes patient pathway, a potential future chief investigator study has been identified. The clinical support team have identified those RSI practices with an interest in undertaking diabetes studies. 13 RSI practices have supported recruitment to diabetes 34

46 LCRN Annual Delivery Report 2016/17 10 Ear, nose and throat Increase NHS participation in Ear, Nose and Throat studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting into ENT studies on the NIHR CRN Portfolio 40% Identify studies that can be opened in CRN SWP sites with the objective of submitting at least one EOI from four Trusts and opening two studies. studies, 3 commercial interventional and 2 noncommercial observational. Currently 3 studies are in set up in primary care. The RDM for primary care attended a meeting with Sentinel Healthcare South West Community Interest Company and has received an invitation to attend and present research opportunities to primary care healthcare practitioners at the quarterly Type 2 education meetings, this will commence in Q /18. Whilst the NATTINA study has opened at PHNT there are issues with recruitment which the ENT CRSL is addressing by linking in with the primary care CRSL to review the patient pathway to try to recruit patients earlier. The recruitment period has been extended by the Sponsor. CRSL reporting very few sites have ENT surgeons willing to take on research. A regional research meeting has been organised for 3rd July 2017 which will be supported by the SWARM lead and RDS. 35

47 LCRN Annual Delivery Report 2016/17 The rhinitis (Dymista) interventional community pharmacy study is in setup. Establish a local multi-disciplinary writing group for ENT research grants to increase the number of local Chief Investigators, with the objective of submitting at least one application for research funding for an NIHR study A collaborative project with Exeter and Truro Speech and Language Departments is now progressing with a grant application. SSS, RDS and PHNT grant writing support has been accessed. 11 Gastroenterology Increase NHS Proportion of acute NHS participation in Trusts recruiting into Gastroenterology Gastroenterology studies studies on the NIHR on the NIHR CRN Portfolio CRN Portfolio 90% Increase the number of sites participating in commercial research from two to four sites in 2016/17. There have been positive EOIs from a new PI at T&S, and YDH plan to open a commercial, observational ulcerative colitis study in Four sites delivered commercial research. GAST 4560 (Ulcerative Colitis) opened at YDH and has recruited 12 patients to date and MOGIC recruited 27. Three commercial studies opened at RDEFT and two at PHNT. GAST 4643 and its extension study open at TSDFT. GAST 5487 (Gastro-oesophageal reflux disease) opened at Beacon Medical Practice in Q3 supported by the network Clinical Support Team. FPFV was achieved and 3 patients have been recruited to date against 36

48 LCRN Annual Delivery Report 2016/17 a target of 2. Whilst not in the prime site relationship, TSFT were recommended to Quintiles for a Crohn s disease study STARDUST and were selected then recruited the 1st global patient. Identify a named member of the clinical Research team to act as research champion who will meet with the RDM and CRSL at each acute Trust and facilitate MDT attendance. Arrange a regional event with a training and education component to improve clinical engagement and collaboration. Meeting in North Devon with CRSL 5/10/16, gastroenterologists and R&D team. The team will now reconsider participation in the IBD Bio-resource study. This is planned to open in Q2 2017/18. CRSL to meet with new clinicians at PHNT in early 2017, date to be confirmed by the clinical team. The planned half day Regional Gastroenterology Research meeting took place in Exeter on 23/11/2016. There was representation from all acute Trust sites (except NDHT) including clinicians, Research nurses and Clinical Nurse specialists. This meeting will continue on an annual basis. Currently, 100% of acute NHS Trusts within CRN SWP have at 37

49 LCRN Annual Delivery Report 2016/17 least one NIHR portfolio study open. Beacon Medical Centre have one portfolio study open. 12 Genetics Full geographic access for patients with rare diseases to participate in Genetics studies is maintained on the NIHR CRN Portfolio Number of LCRNs recruiting into multi-centre Genetics studies through the NIHR UK Rare Genetic Disease Research Consortium 14 (of 15) 100% of Trusts in the SWP have access to the support of the regional genetics clinicians and counsellors. This service enables Trusts to access research approved under the principles of the musketeers memorandum. By the end of Q2 The regional genetics service in conjunction with the CRN SWP will produce study specific guides to recruitment for all open studies to aid clinicians and genetic counsellors in the identification of patients suitable for participation in research. Cancer and Non-Cancer Study guides to recruitment have been developed, Cluster 1 RDM and administrator to support Regional Genetics Service in continuing to update guides. 13 Haematology Increase trainee involvement in supporting recruitment to Haematology studies on the NIHR CRN Portfolio Number of LCRNs with a named Haematology Trainee 15 (of 15) Specialist Research Registrar for Haematology to be appointed by the end of Q2. Regular research activities to include attendance at Quarterly Blood Club meetings, attendance at annual haematology study day and regular review of both current and pipeline haematology studies with RDM & CRSL. Dr David Tucker was appointed as Specialist haematology research Registrar for CRN SWP and receives 1 PA to support his activity. Activities have included the championing of non-malignant haematology trials across the region with fellow Spr s and attendance at relevant training days and meetings. Dr Tucker also presented several case studies at the annual SWP haematology study day. 38

50 LCRN Annual Delivery Report 2016/17 A group of registrars are in the early stages of developing an ITP registry trial looking at a number of outcomes. This work is to be carried forward into 17/18. Subject to availability on the portfolio, the appointed SpR will take on principal investigator responsibilities for at least one portfolio adopted study during 2016/17. There we no suitable studies for a Registrar to be PI for in year. CRSL to speak to all SpRs working in haematology regarding non-malignant Haematology trials portfolio at scheduled training days from Q1 onwards. The RDM for cluster 1 and CRSL attend Spr training days, when appropriate, to promote the research activity of the CRN and studies available. 14 Health Services Research Develop research infrastructure (including staff capacity) in the NHS to support clinical research Number of LCRNs with a lead for HSDR 15 (of 15) The appointment of a Health Services and Delivery Research lead working within the clinical service. The Division 5 CRL approached several potential CRSL s within the region in 2016/17 and previously including the PenCLAHRC - all declined to undertake role. The network will continue to seek a lead. HSR is supported by other network leaders and is currently 5/15 adjusted for population for recruitment to HSR studies. 15 Hepatology Increase access for patients to Hepatology studies Number of LCRNs recruiting into a multicentre study in all of the 15 (of 15) To increase the number of acute sites participating in commercial studies from one HEPA 5441 will no longer open in the UK. 39

51 LCRN Annual Delivery Report 2016/17 on the NIHR CRN Portfolio major Hepatology disease areas: Viral Hepatitis, NAFLD and alcohol, Autoimmune Liver Diseases including (AIH, PBC and PSC) to two, with the RD&E and PHNT opening HEPA The specialty will broaden its scope by opening UK-AIH at two more CRN SWP sites (currently open at RCHT), and become part of the HCC UK group. The REGENERATE study has opened at 3 sites - PHNT, RDEFT and RCHT. Positive EOI received from the RD&E November, 201 for the UK- AIH study. Awaiting set-up at site anticipated to open Q /18. Study also opened at PHNT Q3. All seven CRN SWP acute Trusts have at least one multi-centre hepatology study open in all of the major disease areas - Viral hepatitis, NAFLD, Auto-immune and metabolic disease. However, due to the small patient populations in some areas, and a very small pipeline of noncommercial studies, recruitment can be a challenge. Recruitment is most successful at PHNT where the South West Liver Unit is situated. The team have recruited 79 patients into 6 non-commercial and 6 commercial studies. RCHT have also recruited into both commercial and noncommercial studies. 16 Infection Increase access for patients to Infection studies on NIHR Increase the number of Infection commercial studies on the NIHR CRN 10% increas e Support sites to submit EOIs for at least one infection commercial study. Site IDs were submitted for 2 studies from 3 sites and 1 GP collaborative group, no studies were awarded. 40

52 LCRN Annual Delivery Report 2016/17 17 Injuries and Emergencies CRN Portfolio Portfolio Open Safetxt study in at least two GUM provider organisations with the objective of recruiting 80 patients. Increase NHS emergency departments participation in NIHR CRN Portfolio studies Proportion of acute NHS Trusts recruiting into Injuries and Emergencies studies on the NIHR CRN Portfolio 50% To support the opening of the RfPB study of Tranexamic acid for epistaxis in all CRN SWP sites (as well as three national sites). This will represent a further new Chief Investigator study within the specialty. SWASFT - Research staff will continue to be funded to support research project delivery and paramedic research training. Identified and circulated two studies, including Safetxt which opened at five sites including NDHT who recruited the 1st global patient; 343 recruited to date. RDM attends the regular trial management group meetings and the study is progressing with a planned opening date of May /7 SWP sites selected. 2 sites declined due to capacity issues (RCHT & TSDFT). Funding continues as per plan. The Trust supports the successful recruitment of patients to the AIRWAYS II which continues to recruit to time and target both locally and nationally. This study is open at all 7/7 acute SWP sites. Q2 publicised growth of SWASFT research activity with CRN league tables PR and the Health Service Journal Clinical Impact award, 2016 shortlisting in Q3.Featured in CRN e- mag, local print media and social media. The region enjoys excellent engagement with ED clinicians (7/7 Trusts currently recruiting to I&E studies) with the Chief Investigator 41

53 LCRN Annual Delivery Report 2016/17 pipeline an opportunity. 18 Mental Health Increase participation in Mental Health studies involving children and young people Number of LCRNs with Child and Adolescent Mental Health Service (CAMHS) champions 15 (of 15) Appoint a Mental Health CAMHS research champion to work alongside MH CRSL. This post will be placed within the CAMHS service in order to offer expertise and promote engagement in this specialty. Jerry Fox has been appointed to the role of CAMHS research champion. Jerry is employed by both Exeter University and Virgin Health Care and his team at Exeter University have agreed to support him in this role and provide links with PenCLARHC. Have one MH study involving children and young people in three of three MH providers. Genetic Research into Childhood Psychosis (CPMS18812) study has opened in DPT, CFT and SOMPAR. Run a second SWP PI training day (START - ST4-6 Applied Research Training) for MH clinicians specifically targeting CAMHS clinicians In collaboration with the Royal College of Psychiatrists SW branch, a PI training day was held in Q4. Twenty Psychiatrists attended the course ranging from Psychiatry associates to Consultant. The event included the WoE region with equal participation from each network. Achieve at least one new PI in MH studies involving children and young people. The event included GCP training enabling all attendees to return to their PO s research ready. Feedback was positive with 80% stating they would seek to be research active following this training. A new PI has been appointed to the Genetic Research into Childhood Psychosis study. This is Dr Tim Hawkins which is his first research 42

54 LCRN Annual Delivery Report 2016/17 19 Metabolic and Endocrine Disorders 20 Musculoskeletal disorders Increase the number of participants recruited to rare disease studies in Metabolic and Endocrine Disorders on the NIHR CRN Portfolio Increase NHS participation in Musculoskeletal studies on the NIHR CRN Portfolio Number of participants recruited into studies of rare diseases on the NIHR CRN Portfolio Number of sites recruiting into Musculoskeletal studies on the NIHR CRN Portfolio 10% increas e national ly Building on the database identification processes from last year, develop one database source for all rare metabolic and endocrine patients and complete a permission to contact process to enable all patients to be contacted for all studies 350 All acute Trusts are active in musculoskeletal research. CRSL to develop regional educational meeting to support greater collaboration between sites for studies with small numbers. Identify specialist nurses in acute, primary and community care settings to support the growth in musculoskeletal studies Work with Livewell SouthWest and other providers of musculoskeletal services to ensure that at least one study is opened in a new provider organisation trial at CFT. On review with the CRSL, the database was deemed unsuitable. The CRSL is now liaising with the regional Genetics lead to ensure rare metabolic disease patients are highlighted. All acute Trusts, and 1 non-nhs provider and 34 primary care sites have recruited to the MSK portfolio an increase from 2015/16. Quarterly regional Webinars are being supported and well attended. A regional educational event was held in Q.3. Specialist nurses from acute, primary and community care settings attended the regional educational event. Examples of best practice were shared. To date there have been no suitable studies to support. The Mocam study was opened at Sentinel South West Community Interest Company, 15 patients have been recruited to date. 21 Neurological Disorders Increase clinical leadership capacity Number of LCRNs with named local clinical leads 15 (of 15) Neurology CNSs will be identified in each specialty area, events/workshops will be CRSL spoke at the regional nurse specialist network meeting in Q2. 43

55 LCRN Annual Delivery Report 2016/17 22 and engagement in in MS; Epilepsy and each of the main Infections disease areas in the Neurological Disorders (MS; Epilepsy and Infections) Specialty Ophthalmology Increase NHS participation in Ophthalmology studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts that provide eye services recruiting into Ophthalmology studies on the NIHR CRN Portfolio arranged in at least three locations regionally to promote the portfolio and highlight the support available to enable clinicians to engage with research. A CNS will be appointed to support the CRL with the MS and epilepsy portfolios. 80% Identify studies that can be opened in CRN SWP sites with the objective of submitting at least one EOI from four Trusts and opening two studies. University of Plymouth researchers will be supported with set up and delivery through the Study Support Service for the biomarker for accelerated ageing in glaucomatous optic neuropathy study with potential for recruitment of 120 over the next 24 months at one site. The following personnel have agreed to assist the CRN in an informal manner but have not committed to a formal designation due to time constraints: CNS Mary Parrett Epilepsy (RCHT) and CNS Julie Collingbourne - MS (RCHT). Recruitment performance has been strong with SWP 2nd adjusted for recruitment (N=520). TSFT opening OPHT5713 in Sept. Target 10 over 18 months. 4 new studies opened in 3 sites. 4 commercial Site ID calls have gone out resulting in 3 positive responses, 1 of which has been selected. Study open and recruiting in Plymouth. Prof Paul Artes has just been awarded a "fight for sight" sponsored study which should be eligible for portfolio support. 'Improving visual field tests for moderate and advanced glaucoma'. Likely number of recruits and the planned timescale: 75 patients, 3 years. 3 sites (PHNT, RD&E, Cheltenham & Gloucester) 44

56 LCRN Annual Delivery Report 2016/17 Consolidate links with the regional ophthalmology trainee network with the aim of establishing a trainee-led audit and research collaborative with the objective of submitting one research funding proposal. The South West Ophthalmology Research Matrix (SWORM) is now set up for collaborative trainee led research. SWORM have developed a web-site, established a committee and have completed a small trainee led proof of concept audit. A "Dragons Den" meeting was recently held to determine the next trainee led research project in the South West -- this is due to start in August. 23 Oral and dental health Increase access for patients and practitioners to Oral and Dental studies on the NIHR CRN Portfolio Proportion of participants recruited from a primary care setting into Oral and Dental studies on the NIHR CRN Portfolio 30% Identify all oral and dental studies open to new site recruitment, aim to submit at least one EOI for each study identified. No commercial EOIs have been received within year. One noncommercial study - Development of oral health initiatives to improve glycaemic control was identified within the diabetes portfolio. 27 primary care sites participated and the region recruited 133 of the 312 UK target. Work with the SWAHSN, the Industry Operations Manager and CRSL to initiate a meeting with Wrigley's with a view to undertaking a commercial/investigator initiated trial or dental research. IOM made contact with Polly Garland, Wrigley Oral Healthcare Programme and Webers Handwick who act as a CRO to discuss possible research collaborations. IOM discussed with SWAHSN to seek any possible collaboration. (July 16). As yet, no opportunities have arisen via SWAHSN; this continues to be followed up. 45

57 LCRN Annual Delivery Report 2016/17 24 Primary care Increase access for patients to NIHR CRN Portfolio studies in a primary care setting Proportion of NIHR CRN Portfolio studies delivered in primary care settings 15% Develop CVs for primary care sites including clinical areas of expertise and interest to allow for targeted Expressions of Interest and collaboration with research leads in the acute trusts. Map primary care provision within North Devon and aim to engage a minimum of three new affiliate sites within that area. Develop a commercial research training programme for Level Two practices with the objective of delivering to a minimum of ten practices. The aim of this training will be to increase the number of commercial expressions of interest submitted by 10% within this RSI level. Site CV s developed and piloted, being used by the CST at site visits. Initial contact made with Lisa Pyrke from Symphony Integrated Healthcare and Glen Price from South Devon and Torbay Resilience group. Invitation extended from R&D manager at Yeovil Hospital to attend joint meeting with Symphony Integrated Healthcare in Q practices now engaged, 9 of which are already in the 2016/17 RSI scheme, the CST will make contact with the remaining nine GP sites and support those that wish to become research active in Q /18. Mapping exercise complete. BIU providing additional data to support CVs and info-graphics. The Clinical Support Team are currently supporting three new affiliate practices within North Devon. Commercial research training programme written and delivered to 13 commercially research naive practices to date. Beacon Medical Practice has successfully submitted 2 commercial EOI s following training. All practices receiving this training 46

58 Identify three research leads from CRN SWP sessional practices, one from each county, to provide timely pre-feasibility data to Quintiles to ensure the appropriate placement of studies within the primary care community. Aim to open 100% of Quintiles studies offered to primary care sites. Pilot the design of pre-set searches to enable standardisation of study feasibility for three studies. Pilot the development of real time prompts (pop ups) for three Chief Investigator studies, to enable early identification and referral to the research teams within participating sites. LCRN Annual Delivery Report 2016/17 also received DRIVE training. Three research leads were identified, all of whom have undertaken pre-feasibility work for Quintiles. IOM and RDM members of the Quintiles Operations Group. IOM and RDM have escalated to Quintiles Prime Site Lead, the need to be included in all feasibility and engagement in order to understand pipeline and ensure quality of feasibilities submitted. All studies offered to primary care have opened at a minimum of one site. Pre-set searches developed and piloted for the Strength study. Work being undertaken to develop pre-set searches for the All-Heart study. Evaluation of this work is ongoing and will be completed 2017/2018. Real time prompts and user guides developed for; Dasher, Garfield HEAT, All Heart and Fluenz The pops have been developed and are currently being evaluated, early feedback is showing positive effect but the completed evaluation will assess impact on RTT/rate of recruitment 47

59 25 Public health Increase the number of Public health studies on the NIHR CRN Portfolio 26 Renal Disorders Increase research capacity within the field of commercial renal disorders research Number of new PH studies entering the CRN (England led) Portfolio Number of renal units recruiting into commercial contract studies 15 There are currently two PH studies open in the region. There have been portfolio potentially eligible studies led by the regional higher education providers which have not been adopted. Two workshops will be held with HEIs in 2016/17 to promote the network to ensure any potential public health protocols are considered for inclusion in the NIHR CRN portfolio. 39 Support our three renal units to submit EOIs for commercial trials with the objective of opening one new commercial study each site Open adult renal patient arm of RADAR in all three renal units with the objective of recruiting 30. LCRN Annual Delivery Report 2016/17 Two regional higher education events have been facilitated to increase awareness and ensure all eligible studies are considered for inclusion in the NIHR portfolio. RADAR having now transferred from the Children s to the Renal portfolio is being actively supported by Plymouth, Cornwall, Exeter and Taunton with 581 recruits within 16/ Reproductive Health and Childbirth Establish a national network of sites supporting reproductive medicine studies Number of LCRNs recruiting into reproductive medicine studies on the NIHR CRN Portfolio 15 (of 15) Develop reproductive medicines CV to ensure studies are effectively targeted to support the national network. There are only two IVF centres in SWP - Exeter and Plymouth. Plymouth uses Truro as a satellite centre and Exeter has Taunton. Further work will be needed to ensure accurate mapping of disease interest to ensure the right studies are supported. Open HTA funded IVF studies HABS Select, Efreeze and Scratch in 4/7 NHS Trusts in the SWP. SCRATCH, HubSelect, and E_Freeze did not proceed at either of the fertility centres as the clinical teams did not feel that they had clinical equipoise when looking at 48

60 LCRN Annual Delivery Report 2016/17 Support NHS Trusts to identify studies suitable for midwives and other non-medics to take on the PI role with the objective of opening at least one non-medic PI led study in three Trusts. the treatment plans of the protocol. ALife 2 has opened in Plymouth. Target is 1 and the team have identified three suitable participants who will be approached. The midwifery champion is actively contacting sites to provide support. It has been identified that a lack of dedicated research midwives may be mitigating against opening obstetric studies and supporting an improvement in this will be prioritised. The regular SWP webinar with teams to compare recruitment across sites and encourage positive recruitment strategies to be adopted have continued. 28 Respiratory Disorders Increase access for patients to Respiratory Disorders studies on the NIHR CRN Portfolio Number of LCRNs recruiting participants into NIHR CRN Portfolio studies in two of the main respiratory disease areas: asthma; COPD; bronchiecstasis; rare diseases 15 (of 15) Region currently has respiratory studies open in six of the acute trusts and three studies in 16 primary care sites. Increase the number of primary care representatives engaging with the respiratory webinars by four sites. RD&E and TST Respiratory Collaboration with an industry partner to provide harmonised commercial delivery to a complex ILD patient population across the East Devon and North Somerset region; enabling patients access and ensuring right studies placed at the right site. Bespoke infographic working with regional respiratory physician and industry partner (Chiesi) to visually 49

61 LCRN Annual Delivery Report 2016/17 show asthma prevalence and community prescribing with a view to build upon access to medication and future collaboration. Recruitment has risen from 210 in 2015/16 to 281, (including at primary care sites from 33 to 64). Working with the Clinical Support Team, six new sites have been identified (Axbridge and Wedmore, Rame Group, Compass House Medical Centre, Rolle Medical Practice, Raleigh Surgery and Stennack Surgery) all were represented at quarterly teleconferences. Identify all primary care sites with an interest in participating in respiratory research, specifically asthma and COPD. RDM s for Clusters 5 and 6 working together to scope practices. Respiratory collaborative meeting with RDM s, IOM, CST representatives and respiratory and primary care CRSL s in place to discuss progressing this work. Complete the mapping process to identify all respiratory CNS s in the region. With the aim of supporting further recruitment. Completed. Contacts list of respiratory CNS s is accessible on the HUB. 29 Stroke Across all LCRNs, % of SSNAP-recorded 6% (1% Within CRN SWP SSNAP recorded There are 972 recruits to Stroke 50

62 average RCT recruitment should be at least 6% of SSNAP-recorded hospital admissions, balanced across the hyper acute, acute, rehabilitation and prevention stroke care pathway, each domain contributing at least 1%. 30 Surgery Increase patient access to Surgery research studies across the breadth of the surgical admissions recruited into RCTs across the entire stroke pathway (hyper acute, acute, prevention, rehabilitation) on the NIHR CRN Portfolio. Number of LCRNs recruiting into at least 11 of the following 15 subspecialties: breast, cardiac, colorectal, per domain ) calculat ed at national level 15 (of 15) admissions for the period Oct 14-Sept 15 (latest available data) is That would give a 6% target of 249 patients recruited into stroke RCTs. Currently the region is achieving overall recruitment of 7% of this (n=293). Known pipeline in the following domains Acute Care, Prevention and Rehabilitation predicts recruitment of >1% however there are no Hyper Acute site within SWP so it is not possible to deliver this target at present. Stroke recruitment goal for FY16/17 is 1350; the known available pipeline for each sector projects recruitment of >6% for RCT. All Trusts providing acute care are recruiting into NIHR stroke studies and we expect to maintain this activity in with the Headpost and Taste studies. Appoint subspecialty leads to facilitate improved identification and promotion of studies. LCRN Annual Delivery Report 2016/17 within CRN SWP for 2016/17. This is 23% of SSNAP recorded admissions; however, the largest recruiting study (PROMOTE 452 recruits) was conducted in TIA patients who were not counted in SSNAP admissions. With PROMOTE recruitment removed SWP CRN achieved a 12% recruitment against SSNAP admissions. Each subspecialty (Hyperacute, acute, prevention and rehabilitation) have all recruited > 1% of SSNAP admissions. The PROMOTE study closed on time and target with over 2400 recruits and was the 2nd highest recruiting study on the Stroke portfolio in the last 2 years. The CRN team worked closely with the local CI and study manager to ensure its successful delivery. All acute trusts are recruiting into NIHR stroke studies. Currently, six subspecialty leads appointed in General, Colorectal, Orthopaedics, Vascular, Plastics and urology. Following discussion with 51

63 LCRN Annual Delivery Report 2016/17 subspecialties endocrine, general, head & neck, hepatobiliary, neurosurgery, orthopaedics, plastics and hand, transplant, trauma, upper GI, urology, vascular Open five studies in 15 of the subspecialty groups. the Clinical Specialty Lead, we decided to focus upon the areas of most potential initially and this was reflected in our appointments. Completed. Studies open include; HEALTH, INFORm and UK FROST in Orthopaedics. The OPEN Trial in Urology. RESCUE-ADSH and Dex-CSDH in Neurology. FIAT in colorectal. BASIL-2 and EVRA in vascular. Each acute Trust to participate in at least one NIHR Portfolio surgical study in 2016/17. Complete. 7/7 acute Trusts are participating in at least 1 NIHR portfolio study in 2016/ Please provide a brief summary of overall performance against the Clinical Research Specialty Objectives. Commentary should focus on key achievements, impacts and key challenges and how the challenges have been mitigated/progress against mitigation activities. The majority of objectives set by the network in order to contribute to the specialties nationally were achieved; commentary above highlights key achievements, impacts and mitigations. With the exception of ENT, there was activity in all specialty areas, with the majority of specialties increasing their activity. Commercial research was delivered in 19 specialty areas and recruitment increased by 10% making the network 4/15 adjusted for commercial recruitment. As previously reported the region has significantly fewer Chief Investigators than other LCRN s and in most cases specialty objectives have been impeded by lack of access to studies rather than lack of interest or engagement with clinical teams. Where the network has CIs there has been excellent performance with the network 1/15 adjusted for population for recruitment to Injuries and Emergencies and Anaesthetics studies; 2/15 adjusted for Stroke, Diabetes and Neurology. Operational difficulties have affected the ability of staff to participate and work has been ongoing to ensure the workforce becomes more flexible and that organisations are supported to form collaborations that span the healthcare community, despite this recruitment rose by 5%. DeNDRoN recruitment rose to 52

64 LCRN Annual Delivery Report 2016/ a 34% increase on 2015/16; this activity was supported by Dementia Leads in each county and collaborative models of delivery across acute and mental health providers. For key achievements also see wall of fabulous stuff Please highlight any Specialties that have been the particular focus of investment locally in 2016/17 and comment on the return on this investment. Funding was reserved for three fellows and was awarded to: support Anaesthetics at PHNT and across the region with a contribution to the SWARM fellow. This has supported recruitment of 1027 at PHNT; the fellow also supported work across the region with total recruitment of 2097 for this specialty; Gastroenterology at RDE where the post supported recruitment of 392 patients and Respiratory and Primary Care at RDE and GP sites where in addition to the acute site, two practices were also supported with Candid and Early Arthritis. Funding for the mental health Trusts was maintained (despite the decrease in the network s overall allocation); important collaborations were formed and strengthened during the year and at year end the network was 5 th adjusted for recruitment to the MH specialty. Lack of studies being offered to the region and the paucity of commercial trials remains a key challenge. Funding was provided for dementia leads in each of the three counties and a rater for Somerset. This investment supported a rise (34% from 2015/16) in recruitment to DeNDRoN studies achieved for the third year and Mental Health recruitment rising from 718 in 2015/16 to Primary Care investment has ensured 53% of practices have recruited to studies which account for 20% of all recruitment. The RSI scheme supported 41 practices receiving level 1 and 2 funding and 12 sessional practices. Each RSI practice had support from a designated member of the networks Clinical Support Team (CST). During the year 50 affiliated practices also recruited to 24 studies. The networks Clinical Support Team research nurses and other staff supported 30 studies at 51 sites and recruited 1294 patients. Funding was also made available for change facilitators embedded in all Trusts and also supporting Primary care sites to make an improvement in RTT by embedding a new approach to study delivery. Significant improvements have been achieved with site level commercial RTT rising from 48% in 2015/16 to 69% (excluding primary care sites acute and mental health providers achieved 75%). For non-commercial study level RTT was 79%, up from 70% in 2015/16 and at site level RTT improved from 49% last FY to 72%. 53

65 LCRN Annual Delivery Report 2016/17 Section 5. LCRN Development and Improvement Objectives 2016/ Please describe your activities and impact against the following objective: a) promote equality of access, ensuring that wherever possible, patients have parity of opportunity to participate in research As previously highlighted, CRN SWP has the least number of CIs and therefore in relation to equality of access and parity of opportunity it is likely that this lack of CIs impacts on whether questions of particular relevance to the region s population are being addressed as well as there being less opportunity for the population to participate compared to other regions. Areas of success are being built on, of note is the SWARM trainees group who were successful in their grant application and delivered their first clinical trial. The ENT specialty lead has also established a research group to collate ideas and consider grant applications. Collaborative delivery models, as previously described and notably in dementia, have ensured new research opportunities can be provided. CFT and RCHT have also collaborated to deliver stroke and Parkinson s and other rehabilitation studies. CFT have focussed on speaking at as many staff events as possible to promote research and encouraging clinicians to speak to their patients about research, the benefit of this raised awareness has been seen in their increased recruitment this year and in particular a primary care dementia practitioner has referred 90% of their caseload which has been added to the growing database of research interested clients. Cancer portfolio maps were developed in 2016/17 to support the promotion of studies for different diseases and disease stages amongst clinicians and patients to support collaborative working and cross referral. These will be evaluated in 2017/18 to assess the impact on referral rates across sites. Maps are also being developed for other speciality areas in 2017/18. The Patient Experience Questionnaire 2016/17 raised interesting findings with regard to promotion of research in speciality areas, patients reported being expected to be asked about research in dementia but less likely in other areas including primary care. An action plan for 2017/18 to promote research in a targeted manner in some speciality areas will be completed. Patient Ambassadors will be identified to support this work. The LPMS was used to look at the reasons why patients did not participate in studies and this demonstrated that not all Trusts entered this data so a pilot will be conducted in 2017/18 to investigate the collection of this data to explore the barriers to participation in more depth. TSFT held a Research Patient Focus Group for cancer research participants. This was to gain an understanding of the participants experience from study approach to study completion. The feedback will be used to inform TSFT of any future continuous improvement projects and act as a mechanism to inform and increase patients, participants, and public involvement and engagement in research. At RCHT the annual Let s talk research, information event was attended by 50 delegates who were made aware of research happening within the trust and given the opportunity to discuss opportunities available to them with relevant staff. PHNT and Livewell SW staff took the teddy bear s trial to Plymouth city centre where teddy bears were weighed and measured to establish the most popular teddy bear design. Whilst the children were involved in this parents were signed up to the research database. 54

66 LCRN Annual Delivery Report 2016/ Please describe your activities and impact against the following objective: b) demonstrate a one-network approach to delivery supported by engagement with and implementation of the Study Support Service The CRN SWP worked collaboratively with WoE, Wessex, and Thames Valley and South Midlands to develop the study support service. Resources were shared and a revised study recommendations was shared nationally. A matrix of responsibility framework was developed by SWP and refined and adopted by the CRN WoE. The national SOPs have been developed into flow charts for ease of use to ensure a consistent study support service in line with national processes. RDMs have attended national meetings to discuss study delivery and have promoted the use of the EDGE KPI pages to support local study delivery learning from others experience as well as facilitating regional and national TCs to support study delivery. 55

67 LCRN Annual Delivery Report 2016/17 Section 6. Operating Framework Compliance Indicators Please complete Table 6.1 with details of compliance with the 2016/17 Operating Framework Compliance Indicators as requested below. Table 6.1: Compliance with Operating Framework Indicators 2016/17 Operating Framework Compliance Indicators 1A Domain: LCRN Management Arrangements Objective: LCRN leadership and management teams are in place as approved by CRNCC Please describe your management arrangements in 2016/17 and comment on the effectiveness of these: 1B CD, COO and DCOO in post as well as an IOM and full or part time RDMs for each Division. The network also has a dedicated Communications Lead. The network was green against the HLO objectives and the majority of specialty and other objectives were achieved indicating the management infrastructure was effective in order to achieve this delivery. Domain: LCRN Management Arrangements Objective: LCRN leadership and management groups (LCRN Partnership Group, LCRN Executive Group, Clinical Research Leadership Group and Operational Management Group) are fully operational Please comment on the effectiveness of operation of each of the Groups, highlighting any issues encountered in their operation: Partnership Group: The Partnership Group meeting was held four times in the year. Achieving above quorate has been difficult despite excellent support from the Chair. The meeting is held by telecom to facilitate participation; it is generally considered that the meeting would benefit from better attendance from PO CEOs whose expertise would be welcome in addressing the region's research ambition. Executive Group: The Executive group has met monthly and has effectively supported the delivery of the networks annual plan. Clinical Leadership Group: This group met monthly including two joint meetings with the OMG and a 56

68 LCRN Annual Delivery Report 2016/17 meeting with the PO R&D Directors. This group is comprised of the CD, COO, six CRLs (one for each division) and also benefits from membership of two Lead Research Nurses/Practitioners on a rotational basis from the partner organisations. This group has effectively contributed to the strategic clinical work of the network. Operational Management Group: This group has met monthly and is chaired by the COO, DCOO, all RDMs and the Communications Lead form the membership which also benefits from membership of two PO R&D Managers on a rotational basis. OMG has also had two additional meetings during the year including all Trust Lead Research Nurse/Practitioners and R&D Managers. 2A Domain: Research Delivery Objective: LCRN Partner organisations adhere to specified national systems, and Standard Operating Procedures and LCRN guidance in respect of research delivery Please comment on progress and achievements against this objective focussing on delivery of the CRN Study Support Service according to national SOPs and guidance for both commercial and noncommercial studies: See appendix 2. Please comment on use of CPMS/LPMS data to support operational delivery processes: Please highlight any aspects of the implementation of the national systems and standard operating procedures where you feel further support is required: LPMS has been rolled out and is used on all acute and mental health trusts. The system is used to both manage (e.g. use of metrics) and support (e.g. use of KPI page) performance. The LPMS is being rolled out in Primary Care this has been prioritised to sessional and practices with higher volume activity initially. Further support re the approach in primary care is welcome. Uptake to the initial practices and satisfaction with the product has been good. However, there are multiple practices with small volumes of activity and there is a potential issue in that using the system infrequently causes issues with training and uptake. The network wishes to avoid a work around and is working to achieve uptake at all practices, further support would be appreciated 57

69 LCRN Annual Delivery Report 2016/17 2B Domain: Research Delivery Objective: Support to NHS organisations for activities relating to assessment, arrangement and confirmation of local capacity and capability, or if applicable, timely processing of study wide and local reviews within the CSP process Please comment on progress and achievements against this objective focussing on provision of support for LCRN Host and Partner organisations to apply the principles outlined by the CRNCC for assessing, arrangement and confirmation of local capacity and capability for studies submitting for HRA Approval or delivery of support for study-wide and local governance review in accordance with the CSP Operating Manual where applicable to the study, which includes the collection and recording of the associated NIHR minimum data points for site set-up: The principles for assessing capacity and capability were developed into a framework which has been implemented across the region. A refined framework is currently being developed for GPs to support the AAC activities. Inflight studies were continually monitored throughout the year to ensure that approval was given where appropriate. A study set up report is produced monthly to support R&D departments and RDMs review all studies in set up across the region. All POs are entering data points for HL04 into the local LPMS, regular monthly reviews of data highlight data quality errors. 2C Domain: Research Delivery Objective: Support the delivery of the Government Research Priority of Dementia Please insert commentary on performance and achievements against this objective not already covered in Table 3.1: See table 3.1 3A Domain: Stakeholder engagement and communications Objective: Promote research opportunities in line with the NHS Constitution for England, including informing patients about research conducted within the LCRN and improving patient experience of research through actively involving and engaging patients, carers and the public in research delivery LCRN to insert commentary on performance and achievements against this objective in 2016/17: See appendix 4. 58

70 LCRN Annual Delivery Report 2016/17 3B Domain: Stakeholder engagement and communications Objective: LCRN communications function and delivery plans in place, and budget line identified LCRN to insert commentary on performance and achievements in 2016/17 against this objective including a figure for total non-staff expenditure on communications: 3C Domain: Stakeholder engagement and communications Objective: LCRN contribution evident in national NIHR/NIHR CRN campaigns LCRN to insert commentary on their performance and achievements in 2016/17 including patient and staff stories collated and media coverage achieved: See appendix 3. A Communications Lead (0.8 WTE) planned and implemented the communications and engagement plan with support from partner organisations communications leads and research delivery teams. The total non-staff expenditure for this activity was 9,888 including required replacement of promotional materials with the new NIHR CRN branding. Investment in professional photography has paid dividends. Much of our photographic material has been used for national CRN communications campaign materials. See appendix 3. All POF requirements regarding patient & staff stories, media coverage and contribution to the national campaigns were exceeded. The CRN SWP communications achievements have been shared as best practice at national communications leads meetings and the communications lead has provided peer support for other CRN leads including writing press releases, how to get media buy-in and templates for branded e-bulletins, newsletters and patient stories guidance. 4 Domain: Continuous Improvement Objective: Promote and sustain a culture of innovation and continuous improvement across all areas of LCRN activity to optimise performance LCRN to insert commentary on activities undertaken to achieve this and their impact. Where activities are outlined in other sections of this report please include the identifier (I&I) to highlight these. There are numerous examples throughout the report that demonstrate improvements- these include business process improvements - funding working group; management of commercial EOIs; AAC activities; PEQ; BIU reporting and infographics; study support service. Core team administrators have standardised processes to support the RDMs and Senior Management and have been using the hub to support these activities The DRIVE service improvement project has also led to a training package that has been evaluated; the appointment of DRIVE Champions who have been responsible for changing the way in which research was delivered within Partner Organisations; IT solutions to support patient identification in 59

71 LCRN Annual Delivery Report 2016/17 primary care; cancer portfolio maps; healthcare videos. The impact of the improvements is captured through formal evaluation for some specific projects, some of the evaluation is ongoing and some have demonstrated impact on improved delivery performance. 5 Domain: Workforce, Learning and Organisational Development Objective: Implementation of LCRN Workforce development plan in partnership with relevant stakeholders and other local learning providers LCRN to insert commentary on performance and achievements against this objective in 2016/17: See Appendix 6. 6A Domain: Financial Management Objective: LCRN Host Organisation and LCRN Partner organisation meet minimum control standards, as specified by the National CRN Coordinating Centre LCRN to insert commentary on their performance and achievements in 2016/17 and any issues encountered: A balanced budget was achieved and the organisation was compliant with the minimum controls standards (as evidenced by the external audit). 6B Domain: Financial Management Objective: LCRN Host Organisation meet minimum requirements for the scope of internal audit work, as specified by the National CRN Coordinating Centre LCRN to insert commentary on their performance and achievements in 2016/17 and any issues encountered: Partner organisations were audited by the Host Management Accountant during the year as well as the Host being audited. 7A Domain: Information Systems Objective: LCRN Host Organisation and LCRN Partner organisation have access to the required information systems and services 60

72 LCRN Annual Delivery Report 2016/17 For each system identified in the table to the right please indicate whether the LCRN Host Organisation and all LCRN Category A Partner organisations have access. If you have responded No, please provide an explanation for each system or service which has not been accessible in 2016/17. CRN national systems Yes No NIHR Hub Yes NIHR CRN Open Data Platform Yes NIHR CRN Central Portfolio Management System (CPMS) Yes 7B Domain: Information Systems Objective: LCRN Host Organisation and LCRN Partner organisation have a Local Portfolio Management System(s) (LPMS) live and in operational use by LCRN funded staff Please describe how you are using your LCRN Hosted Local Portfolio Management System to support the management of your portfolio across your LCRN Partner organisations The LPMS EDGE is embedded in all acute and mental health Trusts and is being rolled out in Primary Care sites. The LPMS is used to produce performance reports, including an EDGE vs ODP recruitment report, and HLO data at site and study level. The other functionality of the system is also promoted during training and in the DRIVE package including the study KPI function and the use of the tool to support financial management. 8 Domain: Information Governance Objective: LCRN Host Organisation and LCRN Partner organisation comply with CRN information governance requirements Already addressed in Section 1 61

73 LCRN Annual Delivery Report 2016/17 Section 7. Host Organisation report on performance against the LCRN Host Performance Indicators Table 7.1. LCRN Host Performance Indicators 2016/17 LCRN Host Performance Indicators 1 Domain: LCRN Leadership and Management Objective: Deliver effective leadership and management of the LCRN Host Organisation actions/approaches and any issues encountered in meeting/delivering against the objective in 2016/17: 2 All Leadership and Management posts were appointed and supported by the Host Executive Lead who Chairs the Executive Group. Issues encountered in relation to delivery are outlined in appendix x risks and issues log and were discussed and actions agreed at the Executive and Partnership groups informed by the Operational Management and Clinical leadership groups. Domain: LCRN Research Delivery Infrastructure Objective: Deliver a responsive and flexible NHS support service that meets the needs of Customers (researchers, non-commercial funders and industry) Host Organisation actions/approaches and any issues encountered in meeting/delivering against the objective in 2016/17: 3 Domain: Financial Management Objective: Deliver robust financial management using appropriate tools and guidance Host Organisation actions/approaches and any issues encountered in meeting/delivering against the objective in 2016/17: The Study Support Service approach is described in appendix 2. Issues encountered in relation to delivery are outlined in appendix 9 risks and issues log and were discussed and actions agreed at the Executive and Partnership groups informed by the Operational Management and Clinical leadership groups. All POs provided returns in a timely fashion and were supported by the Host finance function to achieve robust and accurate return data. The on-site audit process was also used by the Host Management Accountant to discuss 62

74 LCRN Annual Delivery Report 2016/17 finance management and to provide further support as required. The Host Management Accountant was a member of the regional funding model review group and provided analysis of use of funds and ROI to this and other meetings. 4 Domain: Allocation of LCRN funding Objective: Distribute LCRN funding equitably on the basis of NHS support requirements Please provide a clear description of the funding allocation method in 2016/17 as requested in the reporting guidance: See appendix 7. 5 Domain: LCRN Governance (Host Board) Objective: Ensure that the LCRN Host Organisation board has visibility of LCRN business and fulfils its agreed assurance role CRNCC will need to have a copy of the relevant minutes from each Host Organisation board meeting in 2016/17 when LCRN contract compliance was discussed, and will check to see if the LCRN has already provided them. If these have not already been supplied, please send them to lcrn.support@nihr.ac.uk Minutes previously provided. 6 Domain: LCRN Governance (Partner Engagement) Objective: Ensure all LCRN Partners are engaged in the work of the Partnership Group Please complete the table to the right, confirming the number of Partnership Group meetings held within the 2016/17 operational year and representation at the meetings. Please also comment on the effectiveness of operation of the Group and any issues encountered, and actions taken to ensure the Group is engaged with primary care, mental health and community sectors. Meeting date No. of attendees Of these the no. of lay attendees 11/04/ /07/ /10/

75 LCRN Annual Delivery Report 2016/17 09/01/17 6 The attendees at the meeting have provided good oversight and strategic advice to support the achievement of the networks objectives including the Chair highlighting issues of concern in communication to PO CEOs, in particular in relation to HLO2. The agenda reflects the need to consider the needs of patients across the healthcare community and membership is drawn from acute, mental health and community partners. Achieving attendance from all Partner Organisations remains challenging. ToRs were refreshed in 2016/17, the meetings are held by telecom to facilitate attendance and R&D Managers and Lead Nurses/Practitioners have been asked to highlight the meeting to their Trusts group member and provide an update and points to raise prior to meetings. The Partnership Group does not currently have lay members. There is a lay Executive group comprised of three lay members the CD and DCOO who meet quarterly and who review network delivery plans and performance and make recommendations in relation to these. 7 Domain: Management of Risk Objective: Establish and maintain an assurance framework and risk management system for the LCRN, including an escalation process Host Organisation actions/approaches and any issues encountered in meeting/delivering against the objective in 2016/17: A network risks and issues log is maintained and an escalation process is in place. Whilst at year end all network HLO goals have been achieved, during year issues were raised which are highlighted in appendix 9. 8 Domain: Management of LCRN Performance Objective: Ensure delivery of LCRN performance against the LCRN Annual Plan 64

76 LCRN Annual Delivery Report 2016/17 Host Organisation actions/approaches and any issues encountered in meeting/delivering against the objective in 2016/17: At year end all CRN SWP HLO objectives have been achieved. Issues encountered are highlighted in appendix 9. 9 Domain: Host Corporate Support Services Objective: Deliver high quality Corporate Support Services as specified in the Performance and Operating Framework Host Organisation actions/approaches and any issues encountered in meeting/delivering against the objective in 2016/17: Corporate support services have been delivered in accordance with POF. 65

77 LCRN Annual Delivery Report 2016/17 Section 8. NIHR CRN Priorities 2016/17 Delivery of NIHR CRN Portfolio studies to time and target (HLO 2) with a specific focus on commercial contract research (HLO 2A) The DRIVE initiative The DRIVE initiative (Delivery of Research ImproVEments) was conceived by the NIHR Clinical Research Network: South West Peninsula to provide a platform for the healthcare community in the region to work collaboratively to understand differences in working practices and identifying ways to reduce variation. Experience of what worked, opinion and an overview was sought by surveys, focus groups, observations of practice and content analysis of existing tools. This led to the development of various tools to support research delivery and a training package to support research delivery staff to achieve better delivery performance. The DRIVE website ( provides an overview of the project and provides a document repository for downloadable tools including Top Tips for Site Initiation Visits and achieving First Patient First Visit metrics, a recruitment planning and capacity and capability assessment tools. There are also two interactive tools on the site Are you ready to assess if teams have considered everything that needs to be done before a study opens and Back on Track to help teams identify why studies are not achieving milestones and what they might do to support better delivery. Underpinning these tools is the DRIVE training package which consists of three modules, Can you do it a module which aims to support staff to undertake evidence based feasibility, Are you ready which aims to ensure a study does not open until all approvals, training etc is complete and Back on Track which supports staff to understand why a study is missing milestones and what they can do to enable better delivery. The package has to date been delivered by trained facilitators to over 320 research staff, facilitators support participants to explore all aspects of study delivery drawing on their own and others experience and being shown how to practically use tools to support delivery including the DRIVE and other tools e.g. ODP. All facilitators will have completed facilitation training prior to completing training in how to deliver DRIVE modules. Website was maintained and promoted during DRIVE training and via the CRN SWP e-magazine. The training package was delivered to >300 staff, an evaluation was undertaken in March 2017 and will support course revision. Course evaluation was collated on an ongoing basis and reviewed quarterly. The course was very well evaluated by participants and the before and after course questionnaire showed participants had greater confidence in their ability to delivery studies following participation. The course wasn t adapted for medical delivery staff in 2016/17 this will be an activity for 2017/18. A Top tips for site selection visits was produced. A staff capacity assessment tool was developed by the CRN SWP BIU to support workforce delivery and management in the delivery of studies. DRIVE initiatives which have improved delivery practice were shared in the CRN SWP magazine and on the DRIVE website as case studies. The CRN SWP Research Network Forum annual event (Q4) included DRIVE Champions presenting examples of success. A bespoke poster was presented to the 66

78 RD&E renal dialysis service for effectively applying DRIVE principles to the set up and delivery of a debut research study. LCRN Annual Delivery Report 2016/17 A significant improvement in RTT was achieved for both commercial and non-commercial studies and at site level. HLO 2a = 67% study level and 69% at sites (75% for acute and mental health trusts). HLO 2b = 79% at study level and 72% at sites. Delivery against the NIHR CRN Strategies Strategy Initiative Progress Communications Communications plan Appendix 3. See Communications plan Appendix 3. NHS Engagement See communications plan Appendix 3 Section 5 for identified See Communications plan Appendix 3. stakeholders and Section 7 for communications framework and methods. Continue to deliver the what s my tribe workshop to all CRN funded staff through the established communities of practices to develop consistent identity with the CRN The Communications Lead facilitated a bespoke workshop for research professionals within three speciality forums to encourage teams to pro-actively share their good news and contribute to awareness raising at local level about research Evaluate study support service early contact service and implement findings into further refining the service. Deliver two joint events with the RDS/CTU/CLAHRC to universities in the region to describe NIHR infrastructure and added value of CRN. participation opportunities for patients. An evaluation conducted at the end of Q4 had positive feedback in relation to the prompt support, costing attribution and support in navigating the processes. The survey was only completed by a small number of CIs and will be amended next year to reflect feedback at different points in the service. The feedback demonstrates a need to clearly define the service and support investigators find sites for their studies. An evaluation conducted at the end of Q4 had positive feedback in relation to the prompt support, costing attribution and support in navigating the processes. The survey was only completed by a small number of CIs and will be amended next year to reflect feedback at different points in the service. The feedback demonstrates a need to clearly define the service and support investigators find sites for their studies. 67

79 LCRN Annual Delivery Report 2016/17 PPIE PPIE plan Appendix 4. See PPIE plan Appendix 4. Working with the life Life Sciences plan Appendix 5. See Life Sciences Plan Appendix 5. sciences industry Business Continue to promote the added value of CRN professional services See Life Sciences Appendix Plan, Appendix 5 development and marketing and signpost where appropriate to support research delivery in the region; attend regional meetings for life sciences partners to promote regional and national opportunities. CV of CRN SWP capacity and capability for research delivery to See Life Sciences Appendix Plan, Appendix 5 continue to be updated to support business growth and conversion of commercial site identifications In collaboration with other NIHR infrastructure and AHSN develop clear signposting to support the set-up of IIT studies, SME supported research and SBRI funded studies See Life Sciences Appendix Plan, Appendix 5 Delivery against the NIHR CRN Goals - see appendix 8. 68

80 LCRN Annual Delivery Report 2016/17 Section 9. Other local innovation and initiatives Initiative Progress Study set up improvement project following HRA processes - a joint project will be identified at the R&D Managers regional meeting to streamline set up processes once the HRA assessment has been embedded in local processes The AAC tool has been developed as a best practice tool to support study set up. This is being further developed next year to provide a summary which can be shared by organisations working on the same study. The CRN SWP staff review the portfolio and identify growth opportunities across all speciality areas this process will be reviewed to ensure better uptake of non-commercial EOIs Study support service improvement project - an evaluation of the service given to Chief Investigators will be conducted in Quarter 2 and improvements made to the service thereafter The primary care service support cost payment processes will be further streamlined to avoid duplication and ensure robust governance processes The Senior Nurse and RDM for Division 5 will identify a CI project to improve delivery in community and primary care settings A standardised tracking process has been developed so that all cluster non-commercial EOIs are tracked. It is too early at this point to look at conversion rates as improvements are being made to the tracker. The service was not evaluated until quarter 4 as there were a number of changes being made to the service and national SOPs. The survey has been sent to CIs in quarter 4 and from the initial evaluation there is positive feedback with regard to promptness of service, cost attribution advice and navigating processes. Improvements for next year will involve a communication s plan to describe the service more effectively and refine the advice and support given. The Financial Accountant has refined the spreadsheets for collating the service support cost payments and an audit SOP has been developed to support better governance. Study pop-ups, standardised clinical coding and processes for sharing information on studies have been developed. The evaluation is ongoing but initial feedback from investigators 69

81 LCRN Annual Delivery Report 2016/17 supports this new processes. The evaluation will determine effect on RTT and other outcomes. A model for funding this in the longer term will be assessed as part of the evaluation. The Administrator forum will build on the projects they have undertaken this year and identify a continuous improvement project to streamline the administrative processes and avoid duplication. An SOP on minute taking was developed. 70

82 LCRN Annual Delivery Report 2016/17 Section 10. LCRN Host Organisation Approval Please confirm that this Annual Report has been, or is scheduled to be, approved by the LCRN Host Organisation board: Signature: Name and position of signatory: Date of signature: Date of LCRN Host Organisation board approval: 71

83 LCRN Annual Delivery Report 2016/17 Appendix 1. LCRN Fact Sheet 2016/17 CRN SWP Fact Sheet Table 1. Key Personnel Host Organisation Royal Devon and Exeter NHS Foundation Trust Host Organisation Chief Executive Officer Suzanne Tracey Host Nominated Executive Director Dr Adrian Harris CRN SWP CD Professor Tony Woolf April 2014 CRN SWP COO Helen Quinn April 2014 CRN SWP Deputy COO Dr Pauline McGlone April 2014 Table 2. LCRN Key Information LCRN Population: Number of NHS Provider Trusts: Number of Category A Providers: Number of GP Practices: Recruitment per 1000 population: 2,249,

84 LCRN Annual Delivery Report 2016/17 Table 3. Local Specialty Leads Ageing A Hemsley April LCRNfunded? Yes Anaesthesia, Perioperative Medicine and Pain Management G Minto April LCRNfunded? Yes Cancer Duncan Wheatley April LCRNfunded? Yes Cancer Subspecialty Lead (Brain) Vacant With effect from: 0 LCRNfunded? Yes Cancer Subspecialty Lead (Breast) Cancer Subspecialty Lead (Colorectal) Cancer Subspecialty Lead (Children and Young People) Cancer Subspecialty Lead (Gynae) Cancer Subspecialty Lead (Head & Neck) Cancer Subspecialty Lead (Haematology) Cancer Subspecialty Lead (Lung) Duncan Wheatley April LCRNfunded? Yes Nader Francis Dec LCRNfunded? Yes Shama Goyal TBC 0 LCRNfunded? No Jenny Forrest TBC 0 LCRNfunded? No David Hwang TBC 0 LCRNfunded? No Paul Kerr TBC 0.5 LCRNfunded? Yes Petra Jankowska TBC 0.5 LCRNfunded? Yes 73

85 LCRN Annual Delivery Report 2016/17 Cancer Subspecialty Lead (Sarcoma) Cancer Subspecialty Lead (Skin) Cancer Subspecialty Lead (Supportive and Palliative Care and Psychosocial Oncology) Cancer Subspecialty Lead (Upper GI) Cancer Subspecialty Lead (Urology) Rory Rickard TBC 0 LCRNfunded? No Toby Talbot TBC 0 LCRNfunded? No Kate Shorthose TBC 0 LCRNfunded? /No Emma Cattell TBC 0 LCRNfunded? No Mohini Varughese Dec LCRNfunded? Yes Cardiovascular Disease Vacant from 01/04/17 With effect from: 1 LCRNfunded? Yes/No Children Dermot Dalton April LCRNfunded? Yes Critical Care Richard Innes April LCRNfunded? Yes Dementias and neurodegeneration Ray Sheridan April LCRNfunded? Yes Dermatology Rachel Wachsmuth June LCRNfunded? Yes Diabetes Duncan Browne July LCRNfunded? Yes 74

86 LCRN Annual Delivery Report 2016/17 Ear, nose and throat Hisham Khalil With effect from: 0.25 LCRNfunded? Yes Gastroenterology Tariq Ahmad April LCRNfunded? Yes Genetics Carole Brewer With effect from: 0.25 LCRNfunded? Yes Haematology Desmond Creagh April LCRNfunded? Yes Health Services Research Vacant With effect from: No of PAs: LCRNfunded? Yes/No Hepatology Matthew Cramp April LCRNfunded? Yes/No Infection Robert Tilley April LCRNfunded? Yes/No Injuries and Emergencies Andy Appelboam April LCRNfunded? Yes/No Mental Health Richard Laugharne April LCRNfunded? Yes/No Metabolic and Endocrine Disorders Bijay Vaidya July LCRNfunded? Yes/No Musculoskeletal disorders Kirsten McKay June LCRNfunded? Yes Neurological Disorders Brendan McLean April LCRNfunded? Yes 75

87 LCRN Annual Delivery Report 2016/17 Ophthalmology Phillip Buckhurst January LCRNfunded? Yes Oral and dental health David Moles April LCRNfunded? Yes Primary care Paul McEleny Lisa Gibbons Dec LCRNfunded? Yes Public health Vacant With effect from: No of PAs: LCRNfunded? Yes/No Renal Disorders Coralie Bingham April LCRNfunded? Yes Reproductive Health and Childbirth Robert Freeman April LCRNfunded? Yes Respiratory Disorders Michael Gibbons April LCRNfunded? Yes Stroke Martin James April LCRNfunded? Yes Surgery Nader Francis April LCRNfunded? Yes 76

88 LCRN Annual Delivery Report 2016/17 Table 4. LCRN Funding Allocations Year Allocation 1 Underspends 2014/15 12,359, /16 11,618, /17 11,171, Core funding excluding top-sliced. Table 5. Sector Spend Year Acute Ambulance Care / Mental Health Primary care Other Total 2014/15* 9,751,289 37, , , ,111, /16* 8,816,697 55, , ,273 54,608 10,223, /17* , ,290 1,046,895 55,965 8,872,813 *does not include cross cutting support or support across sectors 77

89 LCRN Annual Delivery Report 2016/17 Table 6. LCRN Cost Per Weighted Recruit by Financial Year 2 / Sector Year Acute Ambulance Care / Mental Health Primary care Other Total 2014/ / / Excludes participants recruited to commercial studies. Spend excludes top-sliced funding Table 7. Audits undertaken in 2016/17 Organisation Brief summary All Acute Trusts and MH Trusts CRN: SWP Host Risk based audit of controls with substantive testing found that Partner Organisations have effective controls in place to safeguard NIHR funded activities, with just one reporting issue related to one PO that their quarterly financial returns were based on AFP rather than the General Ledger. This issue has now been corrected. Audit South West audited the Host for the Design of Controls and Operation of Controls of the LCRN Core Function. The audit result was green (low risk). 78

90 LCRN Annual Delivery Report 2016/17 Table 8. Category A Providers Cornwall Foundation Trust Devon Partnership Trust Northern Devon healthcare NHS Trust Plymouth Hospitals NHS Trust Royal Cornwall Hospitals NHS Trust Royal Devon and Exeter NHS Foundation Trust Somerset Partnership NHS Foundation Trust South Western Ambulance NHS Foundation Trust Taunton District Hospitals NHS Trust Torbay and South Devon NHS Foundation Trust Yeovil District Hospitals 79

91 LCRN Annual Delivery Report 2016/17 Table 9. HLO Performance HLO / / /17 HLO 1 21,814 23,229 24,838 HLO 2a 43% 25% 67% HLO 2b 72% 79% 79% HLO 4 4 XX% XX% 78% HLO 5a 4 XX% XX% *60% HLO 5b 4 XX% XX% *67% HLO 6a 100% 100% 100% HLO 6b 75% 72% 82% HLO 6c 67% 53% 53% HLO Excludes HLO /15 and 2015/16 data greyed out as the measures for these objectives have changed in 2016/17 and are not comparable with previous years *not a Lead LCRN 80

92 LCRN Annual Delivery Report 2016/17 Table 10. Study Data Year Total Commercial Non-commercial Interventional Observational Total Interventional Observational Total 2014/ / /

93 Appendix 2 CRN: SWP Study Support Service quarterly progress updates Quarter Progress update 1 Processes have been established to ensure early contact, support study set up and ensure national study delivery assessment. A paper is being drafted to set out the components of the SSS which will be delivered central through the Study Support Services Co-ordinator and what will be delivered through the Trusts. A face to face session is being organised with the RDMs to review the involvement from study idea to study closure to provide greater clarity. A survey is in development to evaluate the service and to refine its delivery. 2 The service is evolving as national SOPs are changed. A framework has been developed and RDMs are undertaking the National Study Delivery Assessments as required. A new Study Support Service Co-Ordinator will be appointed and the service will then be evaluated 3 A new matrix of responsibilities has been developed for multi-centred, single site and commercial studies. The lead for the Study Support Services has been working with 3 other LCRNs on the development of a new study recommendations which is now under review nationally. The responsibilities of R&D departments is defined within the matrix to ensure that the study support service is embedded within R&D offices. A new matrix of responsibilities is being developed for commercial and single site studies 4 An evaluation survey has been disseminated and early feedback is showing that the service provides prompt feedback, good advice on cost attribution and signposting. There are improvements to be made on defining the service, communicating the service offer and ensuring consistency. The recently revised study recommendations and NSDA have been completed on 5 studies. The service has had early contact with 30 Chief investigators and this will allow for more feedback next year and a continued refinement of the service

94 Appendix 3 EVALUATION To ensure the implementation of this plan is effective and communications are improving as a result, bi-annual reviews will be carried out by the Communications Lead with the COO. The COO will in 1:1 reviews with the Communications Lead measure performance against the communications work plan as a service review and as the appraisal of the Communications Lead performance. Work plans for external & internal communications 2016/17 Strategic objective Increase the number of participants recruited into NIHR CRN portfolio studies. i)promote benefits of participation Specific local CRN activity Promote positive benefits of research participation for patients & the public at a SW regional locality level. Contribute to NIHR Our Stories campaign & meet national set communications targets. Measure of success Promote at least one patient story per calendar month via CRN communications channels, general media & partner organisation channels. Progress Exceeded national PoF target of 3 for year. By end of Q4 eight patient stories promoted plus 2 PPI case studies. Q3 Contributed case studies for PRAI web pages & national posters. Promote patient experience testimonials by social media. Raise awareness of research success in the SW to promote opportunities for patient/public participation. Tweet at least one patient story per calendar month & direct to full story in CRN e-mag on website resource page Publicise 10 research success stories via CRN communications, general media & specialist press & online/social media. Pilot e-mag specifically for Every CRN SWP e- mag patient front cover & story inside. Exceeded target. 10 patient testimonial image quotes & 6 researcher testimonial quotes tweeted by end of Q4 Exceeded target. By end of Q4 issued 31 press releases to local media & external POs. Achieved. Issued bespoke

95 Support NIHR communications campaigns. public readership about PPIE supporting research. International Clinical Trials Day League Tables HSJ Awards Join Dementia Research INVOLVE e-magazine pilot edition for public Dec Intend to develop with PPI. Achieved. Launched first cartoon patient story in North Devon. Media coverage in Yeovil and Torbay. Good engagement by POs with activities & public events. Achieved. Positive coverage of SW ambulance service top recruiter in local media & emergency medicine press. Achieved. Positive coverage of shortlisted in 2 print media, 2-page mag spread, online news & Healthwatch Devon & Cornwall newsletter & websites. Article in EMed Journal about RD&E ED. Achieved. Q2 Healthwtch Devon promo JDR website/ newsletter Q3 Hosted research three county events for Memory Cafe leads to deploy as JDR champions in their community. Q3 Produced 3 short films for JDR website

96 with study participants One millionth primary care recruited person Q4 Local promotion of JDR Clinic Support Cards national materials to primary care, acute & community memory clinics. Q4 PR set up with three press releases to focus on highest recruiting practice in each county with images & social media tweet material. ii) Grow the number of primary care professionals aware of and engaged with the research agenda. Dispel common myths associated with research to overcome barriers to participation. Promote research activity, success and patient benefits direct to primary care community. Communications Lead to produce a film dispelling 10 research myths for use on Network organisation websites and for talks/presentations for patient/public audiences. Create a communications & engagement plan for primary care. Distribute CRN SWP summary booklet of clinical research for primary care. Provided 3 case studies for Patient Research Ambassadors Initiative for new NIHR CRN web & posters. Q3 Produced 10 myths pop up banner. Film deferred to next year pending PO evaluation of pilot in Torbay to adopt best practice. Achieved Q2 Developed with Cluster 5 CRSL & CRN CST. Achieved Q4 summary booklet reviewed & updated for primary care event.

97 Implement primary care communications plan. Achieved Q3 Publicised 3 GP research stories in local media & 2 PPIE case studies. Monthly GP E-bulletin for research news. Q3 Produced & distributed branded PP slides for waiting room screens to all 152 practices. iii) Increase relationships with charities to foster collaboration for mutually beneficial communications. Promote research success & patient stories targeting relevant health specialty charities. Share 8 positive stories or research updates with relevant health condition charities for onward promotion. Q3 Offered GPs professional review of practice website profile of research & info. This has been taken up by 9 practices and is ongoing. Achieved In all patient story promotion we have provided the words and picture case studies to national health specialty charities including Diabetes, Cystic Fibrosis, Renal and Respiratory to use on their own websites and in newsletters for supporters. Strategic attendance & involvement at charity partner events/forums to raise awareness of research. CRN SWP CRSL for dementia presented a talk at Plymouth Dementia Conference attended by 200 professionals and patients/carers of

98 iv)make it easier for patients/public to access information about studies they can participate in. Improve the quality of research information & signposting on Network organisations public websites. CRN SWP to identify partner events & host memory cafe coordinator events to promote JDR. Communications Lead to support research active organisations to improve research content on websites. Link to UK clinical trials gateway. people with this condition. Promoted JDR and 60 sign up leaflets taken by delegates. Q3 Hosted three events in each county in SW for Memory Café coordinators with sponsorship from dementia care providers. Attended by 58 co-ordinators who returned to their localities with JDR promotional materials. Somerset Care largest dementia nursing care provider in county ran a JDR article in magazine. Passed on Memory Café leads to the national JDR marketing team for ongoing engagement. Promoted JDR Memory Café initiative on local Healthwatch websites. Provided advice to all acute and mental health trusts to improve research info on their sites. Mapped all 112 GP practice leads to update surgery websites and waiting room screens. Provided all practices with generic slides for screens.

99 Provided all GP practices with 10 best practice principles to improve research web content. Communications Advice clinic at CRN SWP event in March Nine practices requested support. Increase the proportion of studies in NIHR CRN Portfolio delivering recruitment on time and to target. Raise awareness of Time to Target (T2T) across the SW network. Provide updates about initiatives, support services & achievements related to T2T delivery via CRN SWP and PO communications channels for staff. Supplied PR story pictures and words to practices including PPIE and ICT Day for practice newsletters & open days. Launched CRN SWP DRIVE internal branded campaign. The campaign activity included best practice examples in the CRN SWP e-magazine and on the DRIVE website. Q2 Produced bespoke posters congratulating the RTT success of debut research team across RD&EFT renal service to build on engagement. Q3 CRN hosted DRIVE workshop - how to maintain engagement with RTT goals in their own trusts. Q4 DRIVE success was showcased at the CRN

100 Pro-actively support (advise practical recommendations) Chief Investigators to plan & implement effective communications/ engagement & recruitment for studies. Pro-actively raise awareness across the Network about the CRN support available to help them deliver T2T. Emphasis on how T2T success achieved for shared learning. Provide effective operational communications to support delivery performances across the Network. Share best practice & delivery success across the Network & promote CRN support services & added value. Establish a process to trigger contact by Communications Lead with CIs. Evidence recommendations to CIs & evaluate with survey of CIs. Promote T2T and research delivery success at Network events & via CRN e- magazine. Share PR materials with POs for onward promotion internally & externally. Produce bi-weekly Core Team news bulletins to ensure timely relevant updates. Produce monthly e-magazine for the SW Network to share best practice, highlight delivery success & promote events, training and support services. SWP annual Research Network Forum event. Q2 Local Study Support Service letter to CIs included new content related to effective communications for recruitment and signposted to CRN SWP Communications Lead. Achieved Regular articles in CRN SWP monthly e- magazine about research delivery achievements. Articles shared for us in partner organisation communications channels including intranet & newsletters. Achieved Q2 Reviewed content and format following a communications workshop for the core team so that e-bulletin is useful and relevant to operational delivery. Achieved Other LCRN communications leads have requested copies of CRN SWP e- magazine to adopt the format for their own use. Patient participant on every front cover and story inside.

101 Support NIHR Communications Strategy objectives The CRN SWP will support, participate & share best practice to develop the Network communications function & effectiveness. Participate in design & delivery of NIHR communications campaigns & planning. Achieved Consistently contributed to campaign coverage & development of the national CRN communications function. Shared Our stories practice as highest LCRN contributor to this campaign. The Communications Lead will contribute to the activity & professional development of the CRN Communications Leads network. Protect Network reputation by adhering to brand identity guidance, Q2 CRN SWP Communications Lead on recruitment panel for West of England CRN to appoint Comms Lead. Q3 CRN SWP Communications Lead assisted with guidance for other leads on how to identify and create patient stories for media use. Q3 Provided peer support to other LCRNs on writing media releases. Q1-4 Contributed to national comms leads quarterly meeting & teleconferences. Supported migration to new CRN pages on NIHR website. Achieved Q2 Started to phase in new brand identity across Network and

102 One NIHR and communications policies & procedures. Inform the Coordinating Centre of planned communications activity & manage any risks. Regular contact with central communications link officer for CRN SWP. promoted one NIHR at partner organisation events. Q3 Compliant on all new materials across the Network. Continue to provide brand identity guidance as required. Achieved Fortnightly forward plan teleconference with CRN central communications link. Escalated issues or PR concerns in timely way through central link.

103 Appendix 4 CRN: SWP PPIE Plan Objective Actions Performance against plan Talk about research in the NHS - We will help See Communications plan appendix 3. raise awareness Identify and train research Communication s Lead worked with Patients and of research by improving the ambassadors/research friends members of the public on the INVOLVE e availability, variety to support awareness raising magazine. This was successfully disseminated to and usefulness of accessible information campaigns. 261 patients and members of the public. This is being reviewed for 2017/18 Make it easy for people to participate - we will work in partnership with patients, carers and the public to reduce barriers Identify members of the public/patients to support the communication lead in developing useful and accessible information Develop a plan with the Communications Lead. This will be used for the utilisation of digital platforms for promoting research opportunities to clinicians and patients. Further work is being done on the patient ambassador initiative for next year. In Q4, patients have been involved in the network induction to support staff in POs to involve patients. The patient stories campaign has been very successful in the region (please see communications appendix). Communication s Lead has supported individual PPIE forums and produced bespoke newsletter for GP practice PPG events. A pop up banner dispelling myths (identified at PPIE meeting in Q2) has been produced & approved by CRN national communications. PPIE representatives and research staff at a CRN facilitated workshop identified the myths. Cancer maps have been developed to support greater awareness of research opportunities in the cancer portfolio and assist clinicians to improve access for patients to available studies. These are being developed for other specialities for next year. Over 120 GP practices have received PP slides for their waiting room information screens with key messages promoting research and CRN initiatives including Join Dementia Research. Three participants (patients and healthy volunteers) have been filmed about their research participation experience for use in talks to public audiences. The films have been on the national JDR website (Q4). Review the findings of the The Communications Lead has advised nine GP practices at their request on the research content on their websites and provided wording and logo artwork to enhance the profile of research on their sites. (Q3) This activity will be ongoing. The findings of the PEQ in were reviewed

104 2015/16 Patient Experience Questionnaire (PEQ). Work with the Trust PPIE research leads to identify areas of poorer experience and implement a plan to mitigate these. With PPIE members and Partner Organisations (PO) design and undertake a PEQ in 2016/17 and review dissemination strategies. This will potentially focus on an end of study PEQ. Work with the regional Clinical Commissioning Groups (CCGs) and POs to identify barriers to research. This work will include integrating questions on research participation into the general patient surveys. A pilot will be undertaken and report completed. and this has led to further work on the barriers to research participation Workshop was held with POs, patients and members of the public and a new PEQ was disseminated for 2016/17. The focus this year was on increasing the responses in speciality areas as a proportion of recruitment activity. The approach take in primary care and mental health aimed to support higher levels of feedback Agreement has been given by Torbay CCG to include some questions but due to CCG priorities these were not implemented. Reach out - we will ensure greater diversity by engaging communities so that a wider range of people get more opportunities to participate and to be involved Use data from these surveys to identify and mitigate barriers at CCG and PO level. Also see Communications plan appendix 3. Lay Executive advisory panel to meet three times per year to review and discuss with key CRN: SWP personnel the annual plan, finance plan and the strategic direction of the network. Each PO to continue to bring a patient ambassador/research friend or equivalent to regional link worker meetings Re-establish joint working group with South West Academic Health Science Network (AHSN), Collaboration in Leadership in Applied Health Research and Care (CLAHRC), Research Design Service (RDS), NIHR Clinical Research Facility and other potential partners to support patient and public A paper was completed and discussed at the PPIE Leads meeting. There is a wide evidence base on barriers to research and this was collated in the paper. It was agreed that data be extracted from the LPMS (EDGE) to explore barriers to research participation. The data was not consistently completed to draw conclusions so in 2017/18 there will be a pilot of using the LPMS to collect this information The Lay Executive met three times in the financial year 2016/17. One member of the Lay Executive participated in the funding model group. There have been 10 patients/members of the public who attended the regional link worker meetings. The plan for 2017/18 is to bring together the Patient Ambassadors at these events. The first PPIE joint meeting was held in February and ToR have been developed with further meetings planned for 2017/18.

105 involvement. This will be across the research pathway, avoid duplication and promote greater involvement opportunities. Work with above working group to identify community based organisations e.g. University of the 3 rd Age, charities/women s Institutes /Colleges and develop promotional materials to support the development of a research ready population Develop DRIVE (joint AHSN and CRN initiative on delivering research improvements) training package to highlight conscious and unconscious bias in relation to Black and Minority Ethnic Groups (BME) and difficult to reach groups. This will provide an opportunity to discuss ways to include all patients accessing the regional healthcare research services. Increase access to learning and development resources to support involvement by promoting Massive Open Online Course (MOOC) (elearning). Building Research Partnerships in collaboration with CLAHRC/RDS (with an aim to train 20 members of the public or patients and 4 facilitators). Develop CRN: SWP induction pack for involvement (with an aim to train 10 people). Develop an action plan for use of POs/primary care PPIE involvement database and disseminate and promote its use to NIHR stakeholders. Establish working group with The joint working group above will be reviewing the promotional materials used across the NIHR and how all groups work with community organisations to avoid duplication. There DRIVE module included information in conscious and unconscious bias and this will be explored further for the next financial year. The BIU will be analysing population level data for next year to demonstrate research access against health care burden. The MOOC learning was disseminated at the link worker meetings and induction being planned for different levels of involvement. An induction leaflet has been developed which will be reviewed at the joint NIHR meetings The MOOC has been promoted through the CRN SWP e-magazine, Core Team news bulletins and social media. The first Building Research Partnership workshop was held and evaluation has been completed and the decision was to not run a second one until after the one NIHR meeting where al training and development will be reviewed. A leaflet has been developed with members of the public and patients. This will be reviewed at the one NIHR meeting A review of the databases has been conducted and new drop box cards created. A process map has been completed demonstrating how patients can support research delivery to ensure that POs are working with patients/members of the public. The data collected on the involvement databases is being reviewed for 2017/18 to support better targeting of opportunities. The CLAHRC and the RDS regularly send requests for identification of patients through the databases, more robust data will be collected on this next year. All Trusts were supported by the Comms Lead to

106 Connect with the public, healthcare professionals and partners - we will increase engagement to improve connectivity and will be innovative in the way we communicate e.g. by the use of digital and social media patient and public involvement for International Clinical Trials day utilising the myths work undertaken by the Communication s Lead Disseminate the work on the research active Patient Participation Groups (PPG) s and develop action plan for challenging CCGs and other PPGs to promote research more effectively. Also see Communications plan appendix 3. Communication s Lead to work with patients/members of the public and Quintiles Prime Site Manager to review how digital and social media strategies can support effective recruitment strategies and support CIs to implement into study design through the Study Support Service early contact. Evaluate the clinical trial video project developed through the Quintiles prime site initiative with Torbay and South Devon NHS Foundation Trust and pilot in primary care to support better clinical trials promotion use patients in planning for ICTD The PPIE Officer and clinical support team have attended 6 PPGs this year where research has been promoted. A patient Ambassador for primary care in each CCG area will continue to support this work in 2017/18. A paper on use of digital technologies has been completed to support study support service early contact service. The CRN SWP have also supported the national CC to undertake a focus group with patients on the use of digital, findings from this will be used locally to support further work on how this can be supported. Further work with Quintiles will be undertaken in 2017/18 to explore how the experience of using social media in industry can be integrated into local CI studies. The evaluation is ongoing but early findings are showing positive effects on RTT and the use of the videos for staff and patient benefits. The project was presented at the Accelerated Digital showcase in Birmingham. The use of the videos is also being explored across the clinical trials pathway and within training. Support and value patient public involvement and engagement - we will strengthen partnerships making involvement a meaningful and effective part of continuous improvement Information Technology Lead to develop minimum Information Systems specification for POs. This will be used to support the use of social media/nihr hub for recruitment of patients into studies and facilitate involvement POs are currently piloting the impact of patient and public involvement in study walk through s prior to studies commencing recruitment. Pilot to be completed written up and presented at Lead Nurse group meeting(s) to encourage this practice across the region. DRIVE training package promotes patient and public involvement in research delivery across all three modules evaluation after each module asks how practitioners will now include patients, for this information to be evaluated and good The minimum specification includes IS support for social media and this has been shared with all R&D Managers to take forward within their organisations. Findings of pilot walk throughs collated and shared with POs. Publicised through CRN SWP e-mag and national CRN INSIGHT online with examples of added value to study set up and delivery. It was also publicised in the first pilot edition INVOLVE for patient/public supporters of research in the SW. The evaluation was completed and examples of how patients can support study delivery was discussed and shared with the DRIVE trainers. The PPIE presentation at staff induction has been amended to support wider dissemination of the good practice and to provide clearer differentiation between engagement and involvement.

107 practice disseminated. Collect at least three case studies on impact of patient and public involvement on study set up and delivery. Share in CRN SWP newsletter. Evaluate the impact of being involved for patients and members of the public by collating at least one case study from each PO. Develop and implement a framework to measure the impact of involvement in research delivery. Participation in regional volunteer co-ordinator meetings so that research is embedded into the usual volunteer activities within POs Two case studies of impact of involvement have featured in CRN SWP e-mag. A third was delayed because of patient illness but will be published in Q1 of next year. Material also used by national CRN comms for PPIE promotion purposes. This has not been achieved as the focus has been on getting the POs to involve patients more this will be taken forward next year. Not being completed as too ambitious - case studies collected and new tool being developed to collect information for next year. PPIE Officer has attended 2 regional patient experience meetings and promoted research involvement. These meetings are not always attended by all POs representatives, the use of attending these meetings are currently being reviewed.

108 Appendix 5 CRN: SWP Life Sciences Plan 2016/17 Goal Objective Activity Progress Investigate root 1.1 Undertake a root cause analysis for each study causes for lack of where the study closes not having achieved projected predictability and recruitment goal and share this learning across the reliability in research region. delivery across the NIHR CRN and explore how data can play a part in resolving this Deliver research with quality, predictability and reliability, benchmarked against global best performance 1.2 Roll out of DRIVE training package and tools to support research delivery (see Workforce development plan and Template devised for RCA outlining reasons why studies failed to meet RTT. Records actions, sharing of practice and mitigation; allowing for a meaningful narrative on causes and encouraging reflective practice on learning. Completed as an initial exercise in Q2. On-going for all closed studies closing in FY. DRIVE training facilitators trained at all sites and >320 staff trained to date. Understand and implement systems and plans to better use data to deliver robust services 1.3 Continue to roll out LPMS (EDGE) to Level 2 practices to support the management and development of the commercial portfolio in primary care. 1.4 Promote use of the SWP page on ODP to enable teams to monitor their sites performance against other sites and facilitate shared learning across sites via established communities of practice. Training completed in Q1-2. CRN SWP BIU and CST led on the training, continued support and mechanisms to ensure data is captured accurately. On-going - bespoke training continues to be offered across the region. SWP ODP App ensures appropriate data is shared and enables greater data cleansing. CRN SWP BIU have (and continue) to share/support LCRNs nationally and supporting the collaborative working with the SW Regional BI Collaboration.

109 1.5 Continue distribution of RAG report on studies due to close in six months to enhance visibility and identify areas requiring additional support. IOM & CRN SWP BIU reviewed process in Q1; commercial analysis report circulated monthly. In addition, RTT report circulated monthly to DRIVE Champions/Lead Research Nurses for analysis/actions. CRN SWP BIU/IOM continue review of data quality and escalating errors in order to ensure correct data reported. Provide services and capabilities that embrace and are adaptable to new technologies and Describe CRN s role in ensuring quality in research delivery Define and develop training on new technologies/ methodologies with Workforce Development 1.6 As a Quintiles Prime Site the region is provided with quality metrics on a monthly basis; IOM to work with Quintiles Prime Site Manager to identify if/where quality metrics are not being achieved and to target further intervention to these areas. 1.7 Work across the region to ensure robust data quality is maintained, working also with industry to understand specific quality issues. 2.1 The workforce development group will complete a review of skills required to deliver the existing and projected portfolio which will consider the needs of the life sciences industry; information from the national work addressing this issue will be disseminated to the group. IOM met bi-weekly with QPSM and attended Operational Meetings. IOM requested in Q2 data points from Quintiles (yet to receive). Improved communication on feasibility requests to IOM has enabled greater flow of local knowledge and placing of the right studies at the right sites. Successful promotion of sites outside the Prime Site - Musgrove Park Hospital - awarded first commercial gastro (Quintiles) study, with new PI. EDGE sprint undertaken in Q3, by CRN SWP BIU to reduce the number of data queries prioritising data queries (from Oct 16 to year end) resulting in improved data (local and ODP). Continued dialogue across the region with POs; bespoke training and support given to all POs. Commercial data check on EDGE/NIHR data (from June 16) raising data errors nationally to ensure robust ODP data.. RTT report distributed regionally and data cleansing across POs improving quality with EDGE/DRIVE Champions. SOP/Escalation written. The WFD Group was disbanded in FY - IOM linked directly with WFD Lead and LRN/P Group to address this issue which is ongoing.

110 methodologies Recognised globally as a valuable assets to UK and international customers, providing a gateway to Europe and the rest of the world Continue to improve and sustain research delivery performance through key performance indicators 2.2 Collaborating with WFD Lead and LRN/P Group in identifying actual and potential training needs of the future workforce to deliver NIHR commercial portfolio studies. Providing information on industry changes in study development and pipeline. 3.1 Implementation of the DRIVE project training package and dissemination of tools to support a sustained improvement in delivery performance (see Workforce development plan and Incorporate industry specific information into the minimum IT specification being developed as part of the IT strategic workgroup to ensure all POs are able to support new technologies. 3.3 In collaboration with the SW AHSN support the development of an IS Platform to facilitate access to data to support new research methodologies and robust feasibility. On-going - working with WFD lead, IOM contributing to proposed Life Sciences current/future requirements; IOM sought industry (3 sponsors) on initial opinion of expected workforce; feedback to WFD Lead to assess impact on workforce regionally - to progress in 17/18 FY. Training package delivered to >300 staff; positive impact observed in metrics along with a greater understanding of how the metrics are calculated. Completed minimum IT document (IOM) and shared with POs and IT Strategic workgroup along with OMG. IOM and SWAHSN collaborated on ideas to create an IS platform; aim is to utilise data sources and access to data-sets whilst raising profile of the SWP. CRN SWP BIU contributed to forthcoming event for Regional Intelligence Analysts Network Launch event (taken place on 27th April 2017). A forum for the CRN SWP to influence, contribute and lead on key BI and data analytics. Work with Business Development, Communications and NOCRI to present a cohesive, value add research delivery service to all 3.4 Undertake a Sponsor feedback survey to ascertain level of satisfaction with local network support and delivery. 3.5 Attend Quintiles Prime Site Executive and Operational meetings and work with the Quintiles team to improve delivery performance and trial new ways of working. Completed 19/1/17 and circulated and shared with CC. IOM attended meetings. IOM requested, via QPSM for access to detailed metrics. IOM contributed to QuintilesIMS Strategy.

111 sectors of the life sciences industry across the NIHR Use stakeholder map to strengthen strategic and operational relationships with key stakeholders around research delivery opportunities locally and nationally 3.6 Continue to work with industry to develop the SWP as new preferred site status; identifying local portfolio needs and ensuring a pipeline for the region (GSK, AstraZeneca, Pfizer Inspire, Novo Nordisk, Intercept, Chiesi etc.). 3.7 Continue to develop a strategic vision to collaborate with external organisations such as Wellcome Syncoma, Bloomsbury Innovation Group, Medpreneur and Crick Industry Route Partnership to expand our existing growth by promoting and fostering interaction and future collaboration on new research studies. 3.8 Work with partner organisations to better understand the non-nihr life sciences portfolio in the region. 3.9 Maintain, analyse and utilise a key contacts list for all regional life sciences partners to include medical/bio-technology companies, local Chambers of Commerce, Universities and MediLink SW Develop collaborations with Medilink South West and the Institute of bio-sensing technology to ensure early identification of companies that can be supported to carry out research with the NHS 3.11 Establish links with local Vanguard sites (South Somerset Symphony Partnership and South Devon and Torbay Resilience Group) to consider local commercial opportunities and to develop evolving collaborations with a view to further research initiatives Undertake a wider stakeholder mapping exercise to inform our commercial growth strategy and enabling links to develop new Chief Investigators (identifying stakeholder needs, expectations and portfolio gaps in disease areas). On-going. IOM working with AZ/Chiesi/Pfizer/ GSK/Novartis/Intercept/ Sandoz/Novo Nordisk and engagement with SMEs re pipeline and promotion of SWP and raised profile to SMEs and bio-similar companies. Continuing into 17/18 FY. IOM spoken with Professor Mythen (UCL/H) in Q2 & 3 to link up possible collaboration.. On-going. IOM regularly met with Lead Research Nurses/Teams/PIs/CRSLs/RDMs to understand the wider portfolio and to inform on pipelines/delivery and feedback from industry. Continuing. Quarterly review of sponsors is undertaken. Mapped local SMEs and aligned to SWP. IOM member of Medilink SW (now Business South West - Europe Enterprise Network) and given summary/profile of the region to support engagement. Initiated with South Devon, planned for Q1 2017/18 with Somerset. Strategy completed in Q2. Facilitated links with Cluster 5 CRL and Attomarker (SME), Cluster 3 CRSL for Renal, Cluster 6 Hepatology & Respiratory CRSLs with Chiesi for pipeline plans for SW. Intercept for hepatology, Becton

112 Develop network expertise and cross stakeholder working within these new stakeholders 4.4 Work with the SW AHSN on the development of their SME innovation pathway to ensure the network describes the service the LCRN can provide with effective signposting. 4.5 Develop a top tips for site selection to support partners to achieve an increase in commercial research business. 4.6 Create a local SWP guide for med/bio tech companies, explaining how to navigate NIHR research pathways to facilitate growth in these areas within the region. 4.7 Continue to work with SWP Community Pharmacy Lead to engage and develop commercial CI/PI roles, support delivery of current and emerging portfolio and utilising pharmacy data for robust expression of interest submissions. Dickinson for infection and Boehringer & QuintilesIMS for new models of working in respiratory between TST and RD&E. IOM reviewed and commented (Q2). Continue to support SW AHSN and established links with SBRI (SW). Completed Q4. Pathway completed. Linking with NENC in terms of collaboration and information to develop formal guidance documents/web tool. IOM met bi-monthly with Pharmacy Lead -. Introduced to Attomarker & Plessey and targeted promotion of region to Pfizer (following on from 15/16). Q2 - Q4 - infographic template, including information on Site IDs and raising profile locally and nationally. Action plan for pharmacy support on primary care studies, commercial approach agreed and this will commence in 17/18 FY.

113 Appendix 6 CRN: SWP Workforce Development Plan 2016/17 Goal Objective Activity Progress 1. Establish flexible 1.1 Actively engage with national workforce workforce models that development team and contribute to national support research delivery initiatives sharing evidence of flexible workforce across organisational and models. divisional boundaries Deliver a responsive and agile research delivery workforce Increase capacity and capability to undertake research in primary care and community settings and ensure patients have the opportunity to participate in research closer to home 1.2 Facilitate regular meetings for Acute and Mental Health Trust Lead Research Nurses/Practitioners (6 weekly) with the opportunity provided to network, provide peer support and share good practice. 1.3 Promote Devon Dementia Collaboration model of joint study delivery across the region and nationally (e.g. poster presentation at R&D Forum conference in May 2016). 1.4 Undertake mapping exercise to identify the capacity and capability of the non-nihr funded research workforce in primary care. 1.5 Adapt the regional research Induction handbook for research practitioners undertaking research in primary care and community settings. 1.6 Establish a contacts list of primary care providers involved with research and disseminate training opportunities (including for example hospices and nursing homes). 1.7 Continue to provide funding for the annual regional primary care event for researchers, clinicians, and research practitioners from primary and secondary care with the aim of highlighting opportunities to support chief investigator studies, research funded by the life-science industry and research collaborations between primary and secondary care. Complete. Attendance at national meetings and monthly telecons. Complete. Six weekly meetings have occurred. Complete. Dr. Ruth Newman attended conference facilitated Q&A session and presented the collaboration poster. Complete for RSI practices. Practice progress forms identify all Research active staff. Complete. Induction handbook updated. Complete. Training opportunities disseminated through e-bulletin. Complete. Event held 21/02/17 at Exeter racecourse with over 100 attendees.

114 Match skills availability to NIHR CRN Portfolio delivery 1.8 Complete an ongoing project to review the skills required to deliver the regional portfolio currently and the skills it is anticipated will be required in the next 3-5 years. Skills mapping completed by WFD group. Further work needed to make this meaningful for future workforce planning. Workshop held with LRN/P group Q4. Provide clearly communicated career opportunities in clinical research Increase research awareness in the NHS workforce 1.9 Undertake a review of research competencies for specific clinical research environments pilot work to be undertaken in the cancer speciality with the aim of facilitating an evaluation of required knowledge and training Undertake a project to identify Domains of Practice within the research nurse/practitioner workforce, this data will contribute to the workforce skills mapping project Continue to support the Research Practice Module (facilitated by PHNT and the University of Plymouth) 2.1 Support the WFD group to map a potential career pathway for non-registered staff from band 2 to band Liaise with higher education providers to maximise the opportunity to deliver research focused sessions for nursing students. Delivery to be undertaken by CRN funded lead research nurses/practitioners. 2.3 Support the lead research nurse/practitioner group to deliver local trust research days to highlight the opportunity to engage in research. Complete. Div 1 RDM and Primary Care lead nurse have reviewed competencies with a view to adapting for specific environments. Decision taken that core research competencies do not need adapting. This work has been superseded by the national Integrated Workforce Model. Complete. Course on-going and funding identified to support facilitator and student fees 2016/2017. This work has been ongoing. Workforce planning meeting held in Q4 provided a preliminary schema which is being reviewed by COO/Lead for Nursing. Complete. Research nurses/practitioners CRN funded staff engaging with the delivery of research modules. Complete. LCRN presence at PHNT research day June 2016 & RD&E Research Day November Enable participation and connection through communities of practice 3.1 Support regional pharmacy group to enable practitioners from across the region to share good practice. 3.2 All RDMs to ensure each specialty group has an established mechanism to enable specialty specific Research Network Induction days completed in all 3 counties. Complete. Regional Pharmacy meeting with hub page set up. Ongoing work needed to encourage sharing, Complete. All clusters have established T/C s. Community annual event & RNF

115 A highly engaged CRN funded workforce Embed learning and skills development in practice Increase capacity and capability of Principal Investigator community Establish core competency framework for research delivery professionals Enable efficiency and productivity of the workforce through high performance Engage and connect our clinical communities exchange of ideas and support. 4.1 All Trusts have committed to increase the number of non-medic PIs in year. Baseline assessment has been undertaken and there are currently 55 aim to increase to Across the region the RCN research nurse competency framework has been implemented with an adapted framework for research delivery staff who are not registered nurses. Information about the international competency framework will be disseminated to Lead Research Nurse/Practitioner group (when available from CRN CC) with a view to reaching consensus as to the adoption of this model. 5.1 Delivery of the DRIVE training modules to support an improvement in delivery metrics by training facilitators in all regional trusts to deliver the three modules: Can you do it? Are you ready? And Back on track 5.2 Monitor the delivery of the 3 modules regionally to ensure standardisation and quality of delivery, review evaluation forms to assess acceptability and efficacy. 5.3 Also evaluate the impact of the training modules through Time to target metrics. 5.4 Deliver the CC Continuous improvement workshop modules across the region to the identified CI leads in the partner organisations. 6.1 Continue to deliver the annual regional Research Network Forum maximising attendance from across the region and professions and evaluating feedback to identify future provide a forum for networking. Increased number of non-medic PIs in region from 47 to 91. In collaboration with the Royal College of Psychiatrists a PI training day was held in Q4. Twenty Psychiatrists enrolled onto the course ranging from Psychiatry associates to Consultant. Complete. International competency framework reviewed by Lead Research Nurse/Practitioner group. Ongoing commitment within region to use competency framework adapted from RCN competencies and used with Enhancing Clinical Research Practice Module. Complete. DRIVE facilitator training complete at all trusts and for the CST. All trusts are delivering DRIVE modules (NDHT accessing training via RD&E). Mental Health trusts accessing training within the acute trust locality. Complete. Delivery of the DRIVE modules at RDEFT, RCHT, PHNT and CST has been monitored. Training review meeting held with facilitators from each PO held March 17. Complete. RTT monitored monthly, positive impact on metric has been observed. Awaiting national sign-off for modules. DRIVE champions have been acting as CI leads within partner organisations. This could be further developed in 2017/18. Complete. Event held 16/03/16 at Exeter Racecourse.

116 environments forums/communities of practice. Provide relevant learning and development in practice settings Also see Regional workforce development group to discuss training needs and develop bespoke training packages where required. Complete. On-going Commercial training package developed for previously commercially research naive practices in primary care. Parkinson s rater training workshop hosted at PSP. Utilised 4 SWP PD clinicians to deliver a bespoke training day. Total of 22 attendees from across the region trained in key research rating scales to support HLO7 Ensure patients and public contribute to learning and workforce development initiatives Develop our clinical leaders The experience and knowledge of patients and the public is valued and heard within a developmental environment 7.2 Senior community research nurse (SCRN) to conduct a training needs analysis for community research nurses and implement a training package as required. 7.3 Signpost available training opportunities (e.g. those provided by CRN Learn and MOOC) via the CRN: SWP newsletter and other means. 8.1 Support the national team to develop the band 6/7 leadership training package by attendance at national meetings. 8.2 Identify the network leadership development needs of the CRLs and CRSLs and provide leadership support and development as required. 9.1 Evaluate of the Building Research Partnerships training and delivery of one further module this year 9.2 Development of induction modules for different levels of patient and public involvement with CRN: SWP activities. 9.3 Promotion of MOOC to support a better understanding of research also see 7.3 Network Induction Day Programme delivered by the LRN/P group. Work commenced Q.1. Reviewed competency document with WFD lead and decision made not to adapt competency document further. Complete. Link to CRN Learn Promoted in CTN bulletin and E-mag. Complete. Advanced Leadership Programme commenced. 4 SWP CRN research staff undertaking training programme in Q.3 Two development meetings were held focussing on network leadership, evolving new models of care and common delivery issues. Complete. Training delivered June Evaluation to be reviewed. Complete. Induction pack developed. Complete. Q2 Press release & social media promoting learning for Patients & public

117 Ensure that our workforce has the skills to contribute to the growth agenda The research workforce has the capacity and capability to deliver research funded by the Life sciences industry The Research Induction Course completed the pilot phase Q4 2015/2016; a review date has been scheduled prior to regional launch. The Regional Induction Handbook to be updated to signpost training opportunities via CRN Learn and MOOC. Continue to support regional GCP training ensuring there is a minimum of one GCP facilitator in each acute trust and actively promote CRN Learn to enable on-line GCP training. Following the Pilot of the DRIVE training modules facilitators will be trained to deliver the course to the research workforce to support an improvement in delivery metrics see Develop an information pack to support R&D teams to open device studies. Map availability of and access to PI training and mentoring ensure promotion of support via CRN: SWP newsletter. Promote via PO PPIE Leads communications tools Q3 Comms lead Pilot Lay e- magazine - promote learning opportunities Complete Complete Complete. GCP facilitators in place, training new facilitators where needed. Complete. Facilitator training complete. Ongoing - DCOO and IOM meeting to review draft; will release in Q1 2017/18. National PI training has been developed recently. GCP lead will attend national teleconference and create roll out plan for region.

118 Appendix 7 Clinical Research Network: South West Peninsula Funding 2016/17 1. Background 1.1 Funding is allocated to the 15 Local Clinical Research Networks (LCRNs) from the NIHR Clinical Research Network national Co-ordinating Centre (CRN CC) to support activities described in the LCRN contract which includes the Performance and Operating Framework (POF). 1.2 Whilst activity forms an element of the model, LCRN budgets are not derived by means of a pass through model. LCRNs are awarded a proportion of a fixed allocation; it is therefore possible for activity to increase with no corresponding increase in allocation if activity in other LCRNs is proportionally higher. Funding is allocated to support all activities outlined in the POF which include research set up and delivery, Patient and Public Involvement and Engagement, Workforce development and continuous improvement in research delivery. 1.3 The national modelling principles used to determine local budget for the 2016/7 budget are: LCRN Leadership and Management for posts defined in the NIHR contract Top slice - National Chairs of specialty groups, a Radiotherapy Trials Quality Assurance service (RTTQA), Paediatric Pharmacy and Formulations Funding, Chemotherapy and Pharmacy Advisory Service (CPAS) A per capita element, approximately 14.8% of the national allocation Project-based funding, that is the number of studies a Trust has opened requiring management (and is not the number of recruits), this includes study-wide and local activities as well as NIHR CRN Study Support Service activities, 6% of national allocation Performance based element to recognise and incentivise high performance in study delivery allocated based on commercial global first patients and time to target performance Recruitment related funding (known as activity based funding (ABF)), approximately 72% of the funding using recruitment over the past two years as a surrogate for all study activity, including for example consent and follow-up. The activity based funding year runs from 1 st October to 30 th September. A simple complexity ratio was used with studies recruiting > attracting 1 point, observational studies 3 and interventional studies 14; it is expected that for data from 1 st April 2015 that the following rations will apply: studies recruiting > attracting 1 point, observational studies 3.5 and interventional studies 11. A Market Forces Factor was applied The final LCRN allocation was then subject to a Cap and Collar i.e. an allocation plus or minus 5% of the previous year s allocation. 1.4 Nationally this is a model predicated on what has happened previously using recruitment activity only as the surrogate for predicting future activity and funding requirement. No national contingency is held and LCRNs are expected to achieve POF objectives within their fixed allocation. This includes funding the Host function; Core Leadership team; Study Support Service; clinical sessions for all professions and other service support costs; Patient and Public Involvement and Engagement; Training and Education and Continuous Improvement in research delivery. 1.5 The delivery allocation made to the Clinical Research Network: South West Peninsula (CRN: SWP) for 2016/17 is 11.2m. There is no additional network Research Capability Funding. 2. Local allocation model for 2016/ The local allocation is not a pass through model and it is necessary therefore to take account of local knowledge including local and national priorities, to resource flexibly to support continued activity as well as to support an increase in activity. Strategically allocations need to be 'necessary and sufficient' addressing capacity, capability and sustainability, whilst managing a decrease in funds. 2.2 The following guiding principles were considered for this allocation: To maintain capacity, capability and stability to protect performance, a funding decrease of no more than 10% with no increase was used (cap based on initial allocations as outlined in finance schedule 1 delivery funds only) Page 1 of 3

119 NIHR CRN High Level Objectives for 2016/17 including the following revised goals: o an increased goal for the number of new commercial studies from 600 to 650 nationally; o an increase in the number of research active GP practices from 25% to 35% nationally o an increase in the number of patient s recruited to DeNDRoN (neurodegenerative studies) from to nationally The key specialty objectives including goals relating to increasing commercial activity, identifying research champions and having specified percentages of certain units e.g. renal units being research active In line with the Government s priority, the HLO7 goal and the regions high dementia incidence (0.74% regionally compared to 0.57% nationally), the LCRN have prioritised dementia research with the budget of the Mental Health Trusts capped at the 2015/16 allocation The potential for organisations to generate other sources of income e.g. commercial Investment in innovative roles and initiatives that will support delivery of the High Level Objectives That Partner organisations will submit a plan outlining proposed use of funds. 2.3 As with previous years the overall budget has first been subject to a top- slice for the following: Host costs: Within the contract and to fulfil contractual obligations, funding for this function is set at 2% or 400k, in SWP this contract is being managed with (1.3% of overall budget), 66% of permitted funds LCRN Leadership and Management: Within this contract and to fulfil contractual obligations the permitted funding for this function is set at , in SWP the senior leadership team budget is managed at % of permitted budget (4.7% of overall budget) Ambulance Trust Research Facilitator: The Trust are successfully delivering an HTA grant; this post is considered the minimum requirement to support ongoing activity with additional service support costs to be paid from the primary care SSC reserved funds Contingency: A small contingency will be held for Trusts to bid against for unexpected service support costs. This is being kept at a minimal level based on experience in the 2014/15 and 15/16 financial years where the call for additional funds has been low with Trust managing the majority of their activity with the initial allocation Roles which provide a service across the region: staff are hosted by partner organisations working across primary care as well as multiple Trusts, there is also a contractual obligation to undertake Patient and Public involvement and engagement activities, training and education and continuous improvement activities Primary Care: Research Facilitator and Research Lead for Live well South West with the same funding as 2015/16; 200k for support service support costs (for the ambulance trust and primary care providers); community research nurses/research officers; research site initiative; General practice clinical sessional support for 12 sessional practices Mental Health providers: Mental Health Trusts funding to be allocated at the 2015/16 baseline level LCRNs are expected to support initiatives to improve feasibility and capacity, within CRN: SWP there is also a concerted effort required to improve time to target delivery. In support of this requirement a proportion of the LCRN performance allocation will fund 2.0 wte band 7 funding will be distributed across Trusts to support an improvement in commercial study delivery using DRIVE principles (allocation of this wte will be determined by the Lead Research Nurse/Practitioner group) and two research fellows at 0.5 wte with matched funds. 2.4 Pass through funding for national Primary Care Lead (hosted in region and nationally determined 58470). 3.1 The remaining delivery funds are allocated to the Acute Trusts with funds for each Trust weighted for activity (ratio of 1:3:14 for 2014/15 and 1:3.5:11 for 2015/16) and capped +0/-10% (with data from the 2014/15 ABF year and from 1 st April to 8 th March for the 2015/16 year). Once the complexity model was applied to data, where there would have been a funding increase, 0% increase applied; 0-10% decrease = 5% decrease applied; 11-20% decrease = 7.5% decrease applied; 21% decrease = 10% decrease. Page 2 of 3

120 4.1 Flow through funding is also included the amount for each Trust will be notified on receipt of guidance from NIHR CRN CC in relation to use of funds. Funds will be released following review and agreement of proposed use of funds which must be decided in consultation with the PI who generated the funds. 3. Allocations Budget of Table 1: Breakdown of pan regional funding Host Training & Education LCRN Leadership Local Portfolio Management System Communications function Midwifery Champion (based at PHNT) 2272 Study Support Service Function Research Nurse regional genetics service (Based at RDE) PPIE Rater band 4 (based at SomPar for Somerset) Business Intelligence function wte band 7 RN delivery improvement Life Sciences Support service National Primary Care Lead Administrative support x 0.5 wte Community RN (based at NDDH & YDH) Clinical Support Team (Primary Care) Community Pharmacy Champion Non-pay (inc meetings, travel, RSI & Sessional Practices materials) Clinical Research Specialty Leads Primary Care Service Support Costs Practice Educator 0.2 wte B7 (based at Contingency PHNT) 2 x 0.5 Research Fellows Table 2: Breakdown of Partner Organisation allocations % change %change CFT RDE DPT SomPar NDDH SWASFT PCH TSDFT PHNT TSFT RCHT YDH There is also additional performance funding to be notified to relevant PI s with the finance guidance from NIHR CRN CC Page 3 of 3

121 Appendix 8 Delivery against the NIHR CRN Goals "It is in everyone s interest to support and achieve advances in health care" 1. Increase the opportunities for all people across England to participate in Health Research 2. Provide researchers with the practical support they need to make clinical research studies happen in the NHS 3. Work as a single network to improve the efficient delivery of high quality clinical research 4. Increase national and international clinical research investment to support the country s growth 5. Provide a co-ordinated and innovative approach to national research priorities Roll out the Devon Dementia Collaboration model of working Achieved and ongoing supported DeNDRoN recruitment of Identify GP practices with a specialty interest to expand communities of practice G.P practices identified with specialist interest including dementia, diabetes, cardiovascular and respiratory disorders. Complete roll-out of EDGE and further develop SWP page on ODP to provide stakeholders with the data they want to improve delivery EDGE rolled out in Acute and Mental Health Trusts and 55 General Practices to date. Grow commercial activity working with partners to maximise the potential of being one of only three UK Quintiles Prime Sites and growing other preferred site relationships Peninsula top recruiting prime site globally in 2016; SWP increased recruitment from 1704 to th adjusted for commercial recruitment overall. Implement DRIVE training, tools and targeted expert support to improve research delivery Training delivered to >300 staff; RTT improved Increase the number of non-medic PI's increased from 47 to 91 Embed the patient contribution to research delivery A pilot of study walk-throughs was completed demonstrating positive impacts on study delivery. The PEQ was completed and data shared to support better involvement; a process map of how patients can contribute to study delivery was shared with the PPIE leads; the Patient Ambassador initiative was implemented. Workforce skills fit for now and fit for the future with career progression for all staff CPD accredited DRIVE training modules delivered to >300 staff. Enhancing Clinical Research in Practice Module facilitated by the University of Plymouth supporting SRN SWP staff to gain a 40 credit degree level module award. Lead Research Nurse / Practitioner in post in all partner organisations ensuring development of the workforce. Skills and career mapping exercise completed by the Lead Research Nurse /Practitioner group. Communications functions support from protocol development to study closure Communications initiatives embedded in Study Support Service Support other trainee networks to adopt the SWARM way of working Three to date: Children s (PenTRAIN); Ophthalmology (SWPRM) and Reproductive Health A growth in CIs achieved with commercial, NIHR and HEI partners underpinned by a Study Support Service effective across the region. The study support service matrix of responsibilities was developed to support a consistent service in the region. Engagement events were held at HEIs; Support clinical trial film project and other digital initiatives to increase awareness raising and recruitment Film project was supported with interim analysis showing a positive effect on recruitment. Linking data from across the region to support feasibility and set up and delivery; used data analytics including disease prevalence/incidence and deprivation linked to disease/demographics and infographics with Life Science and non-commercial CIs; highlighted clinical priorities and population needs e.g. Intercept (hepatology), Chiesi (respiratory), Quintiles IMS (gastro, cardiology), Becton Dickinson (infection) and supported CI study development in autism and smoking cessation. Migration of EDGE and ODP data provided real time performance management. Working with industry to enable growth regionally and to highlight

122 Project/Workstream Name Risk/Issue Register Specialty or cross Date cutting area Identified Cross Cutting - research management and governance Raised by 8/6/2016 DCOO Description Risk: The changes in study set up with HRA processes are affecting set up times for studies. With the loss of CSP there is also less oversight of the studies coming through to detect early problems with set up. IMPACT: There will be less studies opening in this financial year which could affect overall recruitment; eligible studies may not get on the portfolio; timelines for study set up are likely to breach the HLO 4 PO/ Region Likelihood (High, Medium, Low) Impact (High, Medium, Low) Current Status (Red, Amber, Region High High Red Mitigating Actions Escalation routes are in place to HRA and CC. Ensuring early contact through the study support service with regional CIs to ensure studies are adopted. 26/08/16 - There will be a review of performance metrics at the R&D Manager's meeting and a review of the data quality within EDGE. There is still a lack of data within EDGE to determine impact of HRA on study set up times, these will continue to be reviewed at R&D Manager's meetings 17/10/ = Researchers are escalating individual studies that need to be priortised in terms of HRA approval and these are being sent to Janet Messer. A review of the performance will be completed at quarter three as there should have been sufficient studies processed through the HRA to determine impact = There are data quality issues with the data in EDGE and an audit is being completed to correct and identify where data errors are occurring = Data points now agreed - expect to report on metric in M11 & 12. Responsible Owner Action Date Status DCOO 8/6/2016 Ongoing

123 Cross Cutting - research management and governance 8/6/2016 DCOO Life Sciences 29/06/216 IOM Risk: Delays in agreement of ETCs for New Devon CCG; Kernow CCG have advised they will not fund any further ETC in 2016/17. IMPACT: Delays study set up and could have impact on HLO4 and recruitment as it reduces recruitment window. ISSUE: Undertake a feedback survey for sponsors. Delayed due to IOM absence. IMPACT: Lack of information to inform strategy and make improvements to service PO in New Devon Area and Kernow CCG Area High High Red Region Medium Medium Green Telecon arranged for 29th June to discuss with Lead for ETCs. 29/08/2016 R&D Managers asked to escalate ETCs issues; meeting held between Kernow CCG and DOO; national spreadsheet will be completed which the co-ordinating Centre have set up to share with DH. 17/10/16 Kernow CCG advise they will not approve any further ETCs for this financial year. PMG reviewing impact and will put on national spreadsheet so that studies are highlighted nationally. Partnership Group advised on 10/10/16; DCOO preparing letter to escalate to NHSE & NIHR CRN CC. PMG had telecon with DH on the 10/11/16 and followed up with correspondence. DH have indicated that there is not much they can do but they are planning on having discussions with NHS England as primary care ETCs appear to be more problematic. DCOO in liaison with NHS England South. CRSLs also putting pressure on CCGs for individual studies. CC have responded to indicate that all ETCs issues to be escalated to Trudi Simmons Julie Bishop; Kathy Scott and CC Tony Siteriou at DH 09/12/16; PMG has sent to all DH contacts and asked for update regarding the NHS England Plan Draft survey completed 19/1/17 (with support from DCOO). Survey will be circulated, confidentially to commercial sponsors w/c 23/1/17. DCOO 27/6/2016 Ongoing IOM 30/9/2016 Resolved

124 Paediatrics CYP /TYA 22/6/2016 RDM - Cluster 1 Children 28/7/2016 SRDM ISSUE: IG risk in relation to information sharing by paediatric shared care sites in SWP to tertiary care centre and CTU where reconsenting has not occurred at age 16 and information has continued to be shared IMPACT: IG risk ISSUE: Collaborative Links with WE for Paediatric portfolio breaking down. IMPACT: Inability to deliver studies under the shared care system efficiently and lack of engagement required for early site selection in sites for vaccine studies. Could affect meeting HLO1 target. PO Low Mediun Green Region Medium Medium Amber RDM meeting with RCHT who have raised the issue (22/6/16). Lead Nurse at RCHT has also raised the issue at Lead nurses meetings. RDM meeting with WoE Network and lead for TYA services 7/7/16 to discuss. Advice sought from HRA 14/7/16, formal response from HRA 18/7/16 and SWP guidance paper written 1/8/16. To be circulated to Lead nurses prior to next Lead Nurse meeting. Circulated by JW Discussed at Lead nurse meeting and due to be discussed at R&D Manager meeting 18/10/16 with a view to achieving a collaborative agreement and subsequent Joint meeting between Senior CRN Core Teams Staff and CRSLs to establish strategies to strengthen links = still awaiting conformed dtae for call - issue raised at CRN CC mid year review. Cluster 1 RDM 07/07/ Ongoing Cluster 3 SRDM Ongoing 30/11/2016 Ongoing Cross Cutting 27/7/2016 DCOO ISSUE: Indemnity for research at Livewell. IMPACT: Reduction in HLO1 and longer timelines for study set up and potential for PO to be unable to offer research opportunities. Livewell medium Medium Amber Regular dialogue with Gill Mills and escalated to Geoff Baines; meeting arranged with indemnity lead. Joint meeting being set up between PHNT and LIvewell re studies that span both organisations 17/10/ = issued raised at national CRN CC CD/COO meeting - national centre will review and advise. DCOO 22/8/2016 Ongoing Reproductive Health 31/8/2016 SRDM - Cluster 3 ISSUE: lack of recruitment at SWP sites. IMPACT: Not meeting HLO1 target, less opportunity for patients. Region Medium Medium Amber CRSL and SRDM have identified 5 studies that are still open to new sites and 2 have responded positively so the studies have been offered to all sites. One of those could be a high recruting interventaional study = DCOO has meet with CRSL & RDM and actions agreed in realtion to identification of new studies. Rosemary Sowden Ongoing Ongoing

125 Cross cutting 17/10/2016 COO Risk: HLO 2a behind target. Impact: reduction in performance premium; reputational risk. Region medium High Red Annual plan for mitigating actions; data quality poor and actual position is better but national data does not show this - action is EDGE sprint and close liason with CRN CC = much improvemetn in the metric - remains a red risk due to potential impact on performance premium. COO Ongoing Ongoing ISSUE: The Capp 3 study being coordinated by the Regional Genetics Service at RD&E cannot currently open at North Devon. North Devon wish to open as a recruiting site because this is a CTIMP. All other SWP sites have agreed to facilitate the study at their hospital with The Peninsula named as the site and liability for the trial being held with RD&E. If not resolvable this could impact on access to the trial for ND ND HIgh medium Red RDM for Cluster 1 has discussed the situation with both sites and CRSL for genetics to try and resolve so that both parties are satisifed, however the situation is currently not resolvable. This has been escalated to senior managemetn at RD&E and LCRN RDM Cluster Ongoing cross cutting 15/02/17 RDM Cluster 1 Cross Cutting 17/01/2017 DCOO ISSUE: Issue: RD&E have now confirmed that they will not be participating in the one cost and contract review process because of the variation in costs that they have seen in studies that are multicentred. Time taken for costing and contracting review has potentially increased as issues have been escalated from the Quintiles Prime Site Manager. IMPACT: Reputational risk and potential increase in contracting times Region High High Red DCOO completing an audit of the one cost to identify where costs differ and to ensure that future cost reviews take account of where the variation has occured. SOP being review and top tips will be developed. The one cost will be part of the agenda at the R&D Manager's meeting Further clarification to be sought to see if process can be amended rather than one Trust withdraw from process. DCOO meeting with the RD&E to discuss proposal to then agree at the R&D Manager's meeting on 14th March DCOO 17/01/2017 Ongoing

126 LCRN Annual Delivery Report 2016/17 CRN SWP Room N8 ITTC Building Plymouth Science Park Plymouth PL6 8BX Tel: Web: 82

127

128 Appendix B Annual Plan NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans

129 Clinical Research Network South West Peninsula Annual Delivery Plan: 2017/18 Version: DRAFT 0.1 Document date: 05/04/17 Delivering research to make patients, and the NHS, better

130 LCRN Annual Delivery Plan 2017/18 Contents Glossary 2 Section 1: Compliance with the Department of Health / LCRN Host Organisation Agreement 3 Section 2: CRN High Level Objectives... 4 Section 3: CRN Clinical Research Specialty Objectives. 13 Section 4: LCRN Operating Framework Indicators.. 37 Section 5: NIHR CRN Priorities 2017/ Section 6: Other local innovation and initiatives Section 7: Financial Management Appendices 44 Section 8: LCRN Host Organisation Approval

131 LCRN Annual Delivery Plan 2017/18 Glossary CI CI CRL CRSL CPMS CRNCC DeNDRoN DH HLO LCRN LSL MHRA CTA NIHR PI PO PPIE PRA RfPB RTT SSNAP SSL CRN SWP Chief Investigator Continuous Improvement Clinical Research Lead Clinical Research Specialty Lead Central Portfolio Management System Clinical Research Network Coordinating Centre Dementias and Neurodegeneration Department of Health High Level Objective Local Clinical Research Network Local Specialty Lead Medicines and Healthcare products Regulatory Agency Clinical Trial Authorisation National Institute of Health Research Principal Investigator Partner Organisation Patient and Public Involvement and Engagement Patient Research Ambassador Research for Patient Benefit (NIHR funding stream) Recruitment to Time and to Target Sentinel Stroke National Audit Programme Sub Specialty Lead Clinical Research Network South West Peninsula 2

132 LCRN Annual Delivery Plan 2017/18 Section 1: Compliance with the Department of Health / LCRN Host Organisation Agreement 1.1. Please confirm that the Host Organisation will deliver the LCRN in full compliance with the DH/LCRN Host Organisation Agreement Terms and Conditions in 2017/18: Yes 1.2. Please confirm that all LCRN Partner organisations will operate in full compliance with the CRN Performance and Operating Framework 2017/18 Yes 3

133 LCRN Annual Delivery Plan 2017/18 Section 2: CRN High Level Objectives Table 1: HLO performance estimates Please complete Table 1, below, inserting the LCRN s estimated outturn performance for 2016/17 and the LCRN s estimated performance for 2017/18 and 2018/19. Objective Measure CRN National Target 2017/18 LCRN estimated outturn performance 2016/17 LCRN estimated performance in 2017/18 CRN National Target 2018/19 (Indicative) LCRN estimated performance in 2018/ Increase the number of participants recruited into NIHR CRN Portfolio studies Number of participants recruited in a reporting year into NIHR CRN Portfolio studies 650, TBC , Increase the proportion of studies in the NIHR CRN Portfolio delivering to recruitment target and time A: Proportion of commercial contract studies achieving or surpassing their recruitment target during their planned recruitment period, at confirmed Network sites 80% 67% CI Studies (2 of 3) against goal of 55% TBC (73% acute and mental health; 49% primary care against a goal of 60%) TBC 75% CI studies (75% PI sites acute and mental health; 55% primary care) 80% 80% CI studies (80% PI sites acute and mental health; 60% primary care) B: Proportion of noncommercial studies achieving or surpassing their recruitment 80% 71% 10/14 CI studies TBC 80% 80% 80% 1 Note: the NIHR CRN High Level Objectives and/or targets may be subject to change following the DH annual review and approval processes for 2018/19. Please provide the LCRN s indicative planned contribution for 2018/19 against the indicative target for 2018/19. 4

134 LCRN Annual Delivery Plan 2017/18 target during their planned recruitment period (72% 124/173 PI sites acute and mental health trusts) TBC (75% PI site level) (80% PI site level) 3 Increase the number of commercial contract studies delivered through the NIHR CRN 4 Reduce the time taken for eligible studies to achieve set up in the NHS A: Number of new commercial contract studies entering the NIHR CRN Portfolio B: Number of new commercial contract studies entering the NIHR CRN Portfolio as a percentage of the total commercial MHRA CTA approvals for Phase II IV studies Proportion of eligible studies achieving NHS set up at all sites within 40 calendar days (from Date Site Selected to Date Site Confirmed ) 675 N/A N/A 700 N/A 75% N/A N/A 75% N/A 80% 100% 80% 80% 80% 5 Reduce the time taken to recruit first participant into NIHR CRN Portfolio studies A: Proportion of commercial contract studies achieving first participant recruited within 30 days at confirmed Network sites (from Date Site Confirmed to Date First Participant Recruited ) 80% 65% (EDGE Data) 75% 80% 80% B: Proportion of noncommercial contract studies achieving first participant 80% 64% (EDGE Data) 70% 80% 80% 5

135 LCRN Annual Delivery Plan 2017/18 6 Increase NHS participation in NIHR CRN Portfolio studies 7 Increase the number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio recruited within 30 days at confirmed Network sites (from Date Site Confirmed to Date First Participant Recruited ) A: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies Number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN Portfolio 99% 100% 100% 99% 100% 70% 82% 70% 70% 70% 40% 52% 45% 45% 45% 22, ,

136 LCRN Annual Delivery Plan 2017/18 Table 2: Commentary on HLO estimates and improvement activities Please complete Table 2, below, to (a) provide a brief justification for the LCRN performance estimates for each HLO, and (b) briefly describe planned local activities and initiatives to improve HLO performance. HLO Justification Planned improvement activities Timescale (e.g Q1 or Q1-4) 1 The recruitment goal has been calculated with partner organisations and is based on recruitment potential in open studies and knowledge of the pipeline. This goal and projection for 2018/19 includes anticipated recruitment of approx to a DeNDRoN study which will open and close to recruitment in 2017/18. Whilst 100% of Trusts are expected to recruit to NIHR studies, the region has achieved considerable success where collaborations have been formed across organisations to deliver studies. A workshop will be facilitated by CRN SWP to bring together providers from across the region to share learning from existing collaborations and to identify what supportive tools should be developed, e.g. SLA s. As well an increasing recruitment, the network has an ambition to increase activity in the areas of greatest healthcare need. CRSLs & RDMs will work with the BIU to identify areas of greatest health care burden (using Atlas of variation and other data) to support the targeted placement of resource and studies. CRN SWP to work with SW AHSN to support formation of Regional Research Collaboration formed with regional stakeholders including local authorities supportive of an increase in research activity. A key part of the CRN SWP delivery strategy has been the funding of Lead Research Nurses/Practitioners in all Acute and Mental Health Trusts and a Senior Research Nurse for Primary care. These posts support portfolio delivery by managing at a Trust level research delivery staff ensuring workforce development and deployment. These key clinical leaders also meet frequently as a regional group to share good practice and identify areas for which a regional approach should be adopted. Funding will be provided in 2017/18 to continue to support these posts. Q1 Q1-4 Q1-4 Q1-4 7

137 LCRN Annual Delivery Plan 2017/18 2 The actions identified for HLO 2A&B are the same unless indicated. Regional group to be formed to consider how to evidence value of commercial and non-commercial research in the region as a means of supporting an increase in activity. Arrange an event with POs to promote sponsorship (currently two organisations do not sponsor any research and there are examples of studies for regional CIs being sponsored outside the region due to lack of regional sponsorship) highlighting risk based oversight and early engagement with the CRN to encourage all POs to offer sponsorship of studies to appropriate studies to boost regional activity. The CRN funded Lead Research Nurses/Practitioners will be provided with a ring fenced allocation to support additional hours and out of hour s payments to support flexible delivery. Q1-2 Q2 Q1-4 A. At a study level 75% is predicted based on performance in 2016/17. This is further supported by the aim to achieve 75% at site level in acute and mental health trusts and achieve 55% in primary care sites. B. At a study level 80% is predicted based on performance in 2016/17. This is further supported by Following evaluation of the pilot of the workforce capacity tool, POs will be encouraged to adopt its use to better understand workforce capacity to support workforce management and deployment. An incentivisation scheme will be developed for teams - this will reward RTT in a new area/site/specialty. (2A) An award recognition scheme for individuals who perform over and above to support delivery will be run with awards presented by patient representatives at the annual CRN SWP Research Network Forum. Funding for the DRIVE Change Champions will be continued in 2017/18; this group will continue to support the embedding of the new approach to research delivery as well as implementing existing tools and processes and identifying and supporting other CI projects that will enable DRIVE aims. Q3 Q1 Q4 Q1-4 Pilot of in depth feasibility with QuintilesIMS to evaluate effect on study set up and RTT Q1-4 8

138 LCRN Annual Delivery Plan 2017/18 the aim to achieve 75% at site level. TriNetX health informatics tool to be implemented [1] [2] in five acute Trusts (also supports HLO5 and see Life Sciences and Business Development Plan, Appendix 1). Pilot the use of the LPMS to record reasons for patients not participating in research, evaluate and review barriers and develop action plan. Develop top tips for incorporating digital as part of the Study Support Service early contact to ensure local CIs consider digital solutions in both their study design and deliverability. Q1-4 Q1-3 Q2 3 N/A See Life Sciences and Business Development Plan (Appendix 1). 4 The study support service will support study level set up so it is anticipated that 80% of studies will be set up within 40 days Review the primary and community research management and support service and make recommendations for future provision of the service. Implement the matrix of responsibilities for the study support service for commercial, non-commercial and multi centred studies with all stakeholders with a mid-year evaluation to ensure it is effective (see example multi-centre studies Appendix 2). Develop assess/arrange and confirm (AAC) toolkit to support study set up in primary care settings and for studies spanning primary and acute/partnership organisations. Arrange monthly regional study setup telecons with R&D facilitators to resolve any setup issues, share good practices and improve data quality for HLO4 Share AAC summaries through the hub to facilitate collaborative working and sharing of information across sites participating in the same studies Develop training on the completion of the HRA Schedule of events and statement of activities to support study sponsors. Q1 Q1 Q1 Q1-4 Q2 Q2 9

139 LCRN Annual Delivery Plan 2017/18 5 The actions identified for HLO 5A&B are the same unless indicated. A. At a study level 75% is predicted based on performance in 2016/17. B. At a study level 70% is predicted based on performance in 2016/17. Review one commercial cost and contract process to ensure continued improvement to support costing and contracting timelines. The Host organisation Executive Lead has agreed to lead on obtaining a regional solution to the management of ETCs from CCGs - a pooled, risk shared model will again be proposed. Implementation of study recommendations for all CI studies with clear timelines for FPFV Funding for the DRIVE Change Champions will be continued in 2017/18; this group will continue to support the embedding of the new approach to research delivery as well as implementing existing tools and processes and identifying and supporting other CI projects that will enable DRIVE aims. Work with LPMS provider to develop an alert system for FPFV following confirmation of capacity and capability. Evaluation of the primary care IT project which utilises standardised clinical coding to support early patient identification Pilot IT project with Torbay CCG to support patient identification in primary care Q1 Q3 Q1-4 Q1-4 Q2 Q1 Q3 6 A. It is anticipated 100% of the region's NHS Trusts Develop speciality specific guidance for providers who need to access primary care PIC activity in each geography (Somerset/North Devon/South Devon/ Exeter/Plymouth/Cornwall) CRN SWP CD to meet Leads for regions STPs to ensure research is embedded in the plans and strategically considered as new models of care are designed and evaluated. Q2 Q1 10

140 LCRN Annual Delivery Plan 2017/18 11 will again recruit to NIHR studies with recruitment in to studies that are already open and those in the pipeline. B. A goal of 70% has been identified, it is expected that all acute Trusts will recruit to commercial studies; there is more limited opportunity for mental health providers and the regions collaborations encourage joint working where the MH providers support commercial research but are not necessarily the lead site C. It is considered achievable that 45% of General Practices will recruit to NIHR studies in 2017/18 based on pipeline and historical activity Continue to provide funds to all of the region's NHS Trusts; support the social enterprise Livewell with both resource and additional staff support as required from the CRN SWP Clinical Support Team (CST) and other non-nhs providers as required. To support all sites and as many teams as possible at those sites to continue to deliver research, a review will be undertaken of all specialty areas and their communities of practice to ensure staff are being supported within and across organisations to work together to deliver research. See Life Sciences and Business Development Plan (Appendix 1). Also see Primary Care in table 4. In 2017/18 CRN: SWP will continue to run the RSI scheme with 12 sessional practices and 40 level 1&2 and also increase the wte of the Clinical Support Team to facilitate research delivery in primary care. The CST will offer a service to practices new to commercial research with an aim of supporting 3 commercially naive practices to open at least one commercial study in Q1-4 Q3 Q1-4 Q1-4

141 LCRN Annual Delivery Plan 2017/ /18. 7 The target for (DeNDRoN) is 3500 because of activity in one study that will be opening next year target is then lower for 2018/19 to reflect this study will no longer be available but is still higher than 2016/17 projected recruitment. Devon Dementia Collaboration will continue to develop its contribution to HLO7 by adding a third element to its structure. The University of Exeter will join this collaborative model under the guidance of new Vice Chancellor Prof Clive Ballard and with additional capacity of a band 6 registered nurse to be funded by UoE. Four studies have been identified to develop this partnership: Sinbad - First DeNDRoN care home study for the SWP; Acadia - Agitation study; Protect (Start) - Local CI study (UoE) & Isei - Novartis MCI study Cornwall will contribute to HLO7 via a partnership between RCHT and CFT. This partnership will focus predominantly on the Parkinson s portfolio and Dementia opportunities. Sunovion CTH-302 will be the first commercial CTIMP undertaken under the partnership model. CFT will provide a PD CNS as PI and RCHT will provide the RGN s to conduct the PD rating scales. The Somerset collaboration (YDH, SomPar & TSFT) will continue to contribute to HLO7 incorporating a band 4 RA employed specifically to work across all three PO s contributing to the collaborative portfolio of studies. Three HLO7 studies have been identified for FY 17/18: Decide dementia; PD Comm & PD Families Q1-4 Q1-4 Q1-4 12

142 LCRN Annual Delivery Plan 2017/18 Section 3: CRN Clinical Research Specialty Objectives List your priority investments to support CRN Specialties in the development and delivery of their 2017/18 Objectives The table below highlights some specific investments. The AFP outlines actual funding allocations for all specialties. Where there is less specialty recruitment activity or for Trusts with less staff, cross cutting staff will be used to support delivery across the portfolio. Table 1: CRN: SWP Priority investments Specialty Investment All specialties All CRSLs are supported with funding ( PA) to deliver their roles as well as CRL, RDM and administrative support. All specialties Funding for 2.0 wte Band 7 Senior Research Nurse to support implementation of the DRIVE initiative to be distributed across PO s to support a sustainable improvement in Time to Target delivery and embed new wyas of working in research delivery. All specialties Funding for Lead Research Nurses ( wte in each acute and mental health trust) to support research delivery across the portfolio. Specialties tbc 60k to support medic and non-medic Research Fellow posts (Trusts to match with 0.5) to support an increase in commercial/non-commercial recruitment awarded via an application process with priority to be given to cross healthcare collaborations and specialty areas - cancer, dementia, gastroenterology, cardiovascular and diabetes where there is a known large commercial pipeline. Dementia 3 x 0.5 PA for Dementia leads for each county to support an increase in PI capacity and recruitment. Mental Health and No decrease in funding for Mental Health Trusts to ensure capacity for DeNDRoN and MH study recruitment. DeNDRoN Primary Care and other Community Pharmacy Champion to strategically review pharmacy support for primary care sites as well as specialties identifying potential and support required for community pharmacists to deliver research studies and act as PICs. Primary Care Funding for the RSI and sessional practices (12) as well as increased funding for the flexible Clinical Support team and community research nurses based at acute Trusts to bridge the primary/secondary interface and support a sustained increase in commercial and non-commercial recruitment. 2 Note: the NIHR Clinical Research Specialty Objectives may be subject to change following the DH annual review and approval processes for 2017/18 13

143 LCRN Annual Delivery Plan 2017/ Describe how you will ensure that LCRN Local Clinical Research Specialty Leads work effectively locally and with the National Clinical Research Specialty Leads. All CRSLs are supported by a Clinical Research Lead, Clinical Director, Chief Operating Officer and Research Delivery Managers and administrative support. Travel and other non-pay expenses to deliver the role are provided by the network. Sessional support is also provided based on the portfolio and the time the CRSL has available to support the role (0.25-1PA equivalent). There is an annual meeting for all CRSLs with the CRLs, CD and COO and other key stakeholders to support the development of the CRSL leadership role and to share common experiences and strategies to support research delivery. CRLs and RDMs meet (TC or face to face) regularly with CRSLs and support CRSLs to manage their communities of practice with meetings and other communication. CRSLs work with RDMs to develop plans to achieve their specialty objectives and to support delivery of their portfolio. CRLs review CRSL activity with RDMs to capture how they are delivering their role and provide support to them to deliver their leadership role across the region. CRSLs are encouraged to attend national specialty meetings and attendance is monitored. 14

144 LCRN Annual Delivery Plan 2017/ Local plans to contribute to achievement of the 2017/18 Specialty Objectives. Table 3: Local contribution to national Clinical Research Specialty Objectives # Specialty Objective Opportunities/Challenges Local contribution and plans to support the objective and grow the Specialty in 2017/18 Timescale 1 Ageing Measure: Named Local Specialty Lead in Ageing Each LCRN to have an Ageing Local Specialty Lead who demonstrates leadership in their region and can provide examples of leadership of initiatives aimed at increasing recruitment and research capacity in their regions Challenge: Lack of studies on the Ageing portfolio. During FY16/17 one study was offered via the CC site identification service. Opportunity: Regional CI research The SWP Div 4 lead and Ageing CRSL will support local CI (Vicki Goodwin) to roll out the region's first CI Ageing study. The Hope study will be open at a total of ten UK sites including five in the SWP area. The pilot study will open soon recruiting 72 patients x 4 sites (2 in SWP and 2 in Yorks) The main study will now open July 2018 recruiting 720 Nationally and 360 in the SWP Q1-4 2 Anaesthesia, perioperative medicine and pain A: Identification of Specialist Registrar Networks in the LCRN ; B. Number of LCRNs where Specialist Registrar Networks are recruiting 15

145 LCRN Annual Delivery Plan 2017/18 management Establish links with the Royal College of Anaesthetists Specialist Registrar networks to encourage and support their involvement in recruitment into NIHR CRN Portfolio studies Opportunity: To continue to work with the South West Anaesthesia Research Matrix to support delivery of a range of NIHR CRN Portfolio studies. The South West Anaesthesia Research Matrix will continue to support delivery of studies at 7/7 CRN: SWP acute hospital sites and will include the COMMAS study (chlorhexidine mouthwash before elective abdominal surgery) which used SWARM s CUPPA study as pilot data. The PQIP (Perioperative Quality Improvement Programme) which will open at 6/7 acute sites and FLO-ELA (Fluid Therapy for Emergency Laparotomies) will open in at least 4/7 sites (TSFT, PHNT, Torbay and RCHT) with a regional recruitment goal of 3-4 patients per site, per month. Q3-4 Q2-3 The SWARM research fellow based at PHNT will begin work on a collaborative grant proposal between primary care, anaesthesia, surgery and care of the elderly teams to monitor cognitive function at the time of major joint surgery (COMPASS). Q Cancer Measure@ Number of LCRNs achieving on-target recruitment into at least 8 of the 13 Cancer subspecialties, where "on-target" means either improving recruitment by 10% from 2016/17 or meeting the following recruitment targets per 100,000 population served: a. Brain 0.2; b. Breast 8; c. Colorectal 3; d. Children & Young People 3; e. Gynae 3; f. Head & Neck 1; g. Haematology 7; h. Lung 4; j. Sarcoma 0.1; k. Skin 0.2; l. Supportive & Palliative care 3; m. Upper GI 3; n. Urology 8 16

146 LCRN Annual Delivery Plan 2017/18 Increase patient access to Cancer research studies across the breadth of the Cancer subspecialties Challenge: Research studies on the breast, haematology, colorectal and skin portfolio are becoming increasingly more stratified in relation to the genetics of the individual patient. This has lead to a reduction in the median number of patients entering trials in these specialties. Challenge: CYP and TYA services are shared with UH Bristol in WoE Network and supported by a collaborative agreement, therefore as a Network whilst we will support achievement of the national metric, recruitment activity will not be mapped to this LCRN. Challenge: Head & Neck research portfolio is limited and clinician engagement across the SWP varies with poor engagement at 2 of the large acute Trusts Facilitate an increase in recruitment of 10% to at least 6 of the 10 Subspecialties that are already achieving per population served metrics. This will be facilitated by CRL & RDM working closely with all 7 acute Trusts to ensure swift dissemination and opening of new studies, active performance management and regular meetings with R&D Directors, R&D Managers and team leaders. Additionally subspecialty webinars, facilitated by subspecialty leads, are to run quarterly to ensure all clinicians are aware of the full portfolio of research available. In line with NHS England strategy: Achieving World-Class Cancer Outcomes: Taking the strategy forward the Annual cancer Symposium will focus on Cancer Prevention at the population level, the 100,000 Genomes project and personalised medicine with a view to maximising engagement for the Genomes Project and encouraging the translation of the project into long term practice. Q1-4 Q1 Challenge: Lack of experience in the delivery of Supportive & Palliative care and Psychosocial Oncology & Survivorship studies as a region Challenge: severe capacity issues within oncology in the whole of Somerset due to the national shortage of oncologists and the inability to full substantive posts at both acute sites. In line with CRUK Cancer & Health Inequalities report the Annual Cancer Forum will this year focus on increasing access to cancer research opportunities for vulnerable groups. This nurseled forum will investigate the blocks faced by patients from vulnerable groups and look at practical ways to ensure equitable access for as many patients as possible Evaluate the use and effectiveness of the SWP Cancer Research Portfolio Maps with the CRN SWP BIU and cancer team leaders, this Q3 Q1-4 17

147 LCRN Annual Delivery Plan 2017/18 evaluation will review data on the number of patients referred between partner organisations for trial participation. Ensure that the Supportive & Palliative care and Psychosocial Oncology & Survivorship specialty recruits, as a minimum 3 patients per 100,000 population served = 66 patients. This will be supported by investigating the ability of the seven adult hospices to deliver palliative care research studies and the six local Macmillan cancer support services to deliver supportive care studies. Continue collaborative working with UH Bristol and develop local SWP work instructions with the 5 Acute Trusts who support the collaborative agreement to ensure adherence to the agreement. Ensure that the Head and neck specialty recruits, as a minimum, 1 patient per 100,000 population served = 22 patients. CRL, SSL & RDM to meet with newly appointed Consultants for Head & Neck at RCHT and PHNT to in order to increase engagement at these sites. Organise meetings with adult cancer research team leaders, paediatric research team leads and TYA nurses at each acute Trust to encourage joint working in the care of teenagers and young adults with cancer, access to trials and transition into adult services. Q1 Q1-4 Q1-4 Q1-4 18

148 LCRN Annual Delivery Plan 2017/18 4 Cardiovascular disease Measure: Number of Cardiovascular studies on the NIHR CRN Portfolio recruiting from >1 site within that LCRN Improve patient access to Cardiovascular Disease studies on the NIHR CRN Portfolio Challenge: The patient pathway for cardiovascular services is evolving within some subspecialties. Increasingly, Heart Failure and Hypertension studies are better placed within primary care as patients are managed outside of hospital. Opportunity: Significant opportunity to increase Cardiovascular research participation across the region and specifically at PHNT given population and services. Produce a cardiovascular study map for the South West region to provide clarity of portfolio opportunities within subspecialties. PHNT have agreed to open at least 2 new commercial Cardiovascular studies. Trifectasurgical study to open with CI at PHNT and another to be sought via Commercial EOI during the year. Facilitate cross regional working on the Trifecta surgical study. With patients recruited at PHNT and follow up carried out at subsidiary sites. Q3 Q1-4 Challenge: Consultant clinician vacancies at RCHT leading to significant capacity issues. Challenge: Activity within specialty has declined over last 3 year. Undertake regional data analysis to support the needs of the population; work with Novartis to identify appropriate studies in CV notably heart failure pipeline. Support research teams to participate in more commercial activity by utilising data and proactive CRSL engagement regionally and with industry. Q1 Continue follow up of current portfolio and identify studies that could be run with non-medic PI or collaboration with primary care sites. Q1-4 BIU to undertake analysis of data to identify local population needs and portfolio gap to inform POs of opportunities and work with industry partner to support site selection. Q1 19

149 LCRN Annual Delivery Plan 2017/18 New CRSL to be appointed. Specialty lead and RDM to produce biannual specialty update. Specialty Lead to review opportunities for engaging trainee network in research. Q1 Q3 Q1-4 5 Children Measure: Proportion of NHS Trusts recruiting into Children's studies on the NIHR CRN Portfolio Increase NHS participation in Children's studies on the NIHR CRN Portfolio Challenges: No tertiary Centre in SWP and those general paediatric studies opening on the current NIHR portfolio are not open to new sites. Opportunity: PenTRAIN initiative for medical trainees in SWP is now launched and starting to develop projects. Work with CRN: West of England Paediatric research teams in order to secure access to studies with the objective of increasing our overall recruitment to studies and seek to join general paediatrics studies group led by Colin Powell. Support PenTRAIN initiative with the objective of submitting one draft research funding proposal and develop plan for supporting for research delivery. Q1-4 Q4 6 Critical care Measure: Proportion of intensive care units recruiting into studies on the NIHR CRN Portfolio Increase intensive care units participation in NIHR CRN Portfolio studies Challenge: lack of pipeline commercial and non-commercial studies. Opportunity: Initiate collaboration with external research active groups such as Bloomsbury Institute of Intensive Care Medicine in order to promote the region and facilitate potential new studies. We will work with new groups such as the COMBACTE (Combatting bacterial resistance in Europe) to increase the number of available studies for Intensive care units to participate in. Increase the number of commercial studies open from 1 (Severe Sepsis/Coagulopathy trial at PHNT) to 2. Q1-4 Q2 20

150 LCRN Annual Delivery Plan 2017/18 Challenge: to deliver commercial studies to time and target. Aim for all 7/7 general intensive care units to have at least one non-commercial portfolio study open, currently 6/7. The 65 Trial (Evaluating the clinical and cost-effectiveness of permissive hypotension in critically ill patients aged 65 years or over with vasodilatory hypotension) has the potential to open at all sites. To improve the number of commercial studies recruiting to time and target from 50 % to 80% by supporting teams in target setting and working with teams outside of CRN: SWP to share recruitment and delivery plans. Q2-3 Q1-4 7 Dementias and neurodegeneration (DeNDRoN) Measure: The proportion of people recruited to Dementia studies on the NIHR CRN Portfolio who were identified via Join Dementia Research Optimise the use of Join Dementia Research to support recruitment into Dementia studies on the NIHR CRN Portfolio Challenge: Increasing the ratio of participants to JDR with a diagnosis of dementia rather than the healthy volunteer ratio - large proportion of the portfolio is for MCI which cannot be recorded and easily accessed on JDR. Opportunity: Increased engagement with primary care research active sites to promote JDR to the dementia diagnosed population. FY 15/16 ratio of dementia diagnosed participants enrolled to JDR in the SWP = 13%. FY 16/17 ratio of dementia diagnosed participants enrolled to JDR in the SWP = 15%. Target for FY 17/18 for dementia diagnosed participants enrolled to JDR in the SWP = 17% Introduce and roll out the National incentive of JDR clinic cards. RSI sites will be provided with clinic appointment cards incorporating the JDR logo and information on how to enrol. Q2-4 Also see CRN SWP Communications Plan appendix 3. 8 Dermatology Measure: Number of Nurse PIs for new Dermatology studies entering the NIHR CRN Portfolio Develop the Opportunity: Senior nurses within the Identify nurses and practitioners within the region Q1-4 21

151 LCRN Annual Delivery Plan 2017/18 Dermatology Principal Investigator (PI) workforce community have been successful in securing grants for audit and service evaluation within tissue viability specialisations. who are undertaking audit and service evaluation across all regional providers of dermatology and tissue viability services and facilitate a community of practice within this group that enables practitioners to further develop their research knowledge and skills with a view to identifying two potential new nurse PI s from this group. 9 Diabetes Measure: A: Increase the number of patients recruited by community services into Diabetes led and supported studies on the NIHR CRN Portfolio; B: Increase the number of community sites participating in studies relating to the prevention of diabetes and its complications Increase primary care recruitment into Diabetes led and supported studies on the NIHR CRN Portfolio Opportunity: Primary care and diabetes have a strong history of collaboration within SWP CRN. Challenge: Nationally the diabetes portfolio has declined and there is a need to maximise the opportunity to work regionally with industry partners to gain preferred status. Industry is currently still targeting secondary care sites (sometimes directly) so there is some promotion needed to highlight that primary care is a more suitable location. The Div 5 RDM will take over the management of the diabetes specialty to provide greater oversight of study placement and activity in primary care. Work with IOM and industry partners (Novo- Nordisk and QuintilesIMS) providing regional demographic data to inform where studies are best placed; including promotion of primary care sites where Type 1 studies are best situated and to identify secondary care studies in gestational diabetes to support pipeline. Q1 Q2 Challenge: Reduction in portfolio opportunities within Diabetes. Specifically DARE study closing. It is likely there will be a significant reduction in diabetes recruitment during as there are no similar registry studies available to SWP CRN sites currently. This may also affect sites ability to recruit to other Produce a Type 2 Diabetes study pathway document to highlight GP practices with a special interest in Diabetes and outline roles and responsibilities within the region for these studies Q2 22

152 LCRN Annual Delivery Plan 2017/18 10 Ear, Nose and Throat studies as DARE was a significant recruitment tool. Opportunity: Local CI is currently developing a protocol for a large scale diabetes study - ABCD. This study would enrol elderly diabetic patients via retinal screening. Measure: Named audiology champion in each LCRN Develop research infrastructure (including staff capacity) in the NHS to support clinical research Challenges: Lack of studies on ENT portfolio open to new sites. Challenge: Lack of engaged ENT consultants outside of Plymouth. Opportunities: CRSL is engaged with CIs outside of SWP and is collaborating on grant applications. There is a multidisciplinary writing group developing an ENT study. Appoint an Audiology Champion. Q1 Open two new ENT studies. Q1-4 Continue to support the local multidisciplinary writing group for ENT research grants to increase the number of local Chief Investigators, with the objective of submitting at least one application for research funding for an NIHR study. This action will also provide an opportunity to promote better engagement with actual study delivery. Q4 11 Gastroenterology Measure: Number of participants recruited into Gastroenterology studies on the NIHR CRN Portfolio 23

153 LCRN Annual Delivery Plan 2017/18 Increase the number of patients recruited into Gastroenterology studies on the NIHR CRN Portfolio Opportunity: CRSL who is experienced Chief Investigator within IBD. Opportunity: pipeline of commercial studies. Currently, 7/7 acute Trusts within CRN: SWP recruit to at least one NIHR portfolio study. This will be supported again in 2017/18 by 6/7 sites opening the I-CARe and/or IBD Bioresource studies. Q1-2 Opportunity: new clinicians at PHNT to be Principle Investigators. The PHNT clinical team lead have identified two new clinicians, one of whom will be PI for the I- CARe study and the other for IBD Bioresource study. It is anticipated that in 2017/18 they will also be able to become PI s for commercial studies. The CRSL, RDM and IOM will visit the team to provide support in this development. Q2-3 To increase participation in commercial studies from five to six CRN SWP acute sites and from one to two primary care sites by working with pre-identified industry partners to map against pipeline and working with new research active practices. The promotion of biosimilars across the region and provision of training on these studies can potentially increase activity (See Life Sciences and Business Development Plan Appendix 1) Q1-4 TSFT to open first commercial study - CELGENE with a target of 2-3 patients. Q1-2 Produce an interactive study map of available studies within CRN SWP region to highlight research participation opportunities across the geography. Q Genetics Measure: Number of LCRNs that have evidenced increased early career research involvement in NIHR CRN Portfolio research. 24

154 LCRN Annual Delivery Plan 2017/18 Increase early career researcher involvement in NIHR CRN Portfolio research Challenges: Nationally there has been a lot of time spent discussing who this objective relates to and to date there is no consensus. Locally initiatives to best support trainees/senior trainees Genomics Champions have been explored. CRSL & RDM to support genetics Spr based at the Regional genetics Service to become more involved in research. Support the roll out of the 100,000 Genome Project in both rare diseases & cancer. Meet with clinical leads & CNS s involved in the project monthly, attend teleconferences and link with Cancer Services managers to ensure success of project in SWP Q4 Q1-4 Support local genomics champions to engage with Trusts and clinical teams in the region in order to disseminate local and national training opportunities. Q Haematology Measure: Number of LCRNs that have evidenced increased trainee involvement in NIHR CRN Portfolio research. Establish links with the relevant Royal College or national society to encourage and support trainee involvement in NIHR CRN Portfolio studies Challenge: Lack of availability of haematology studies on portfolio Opportunities: Senior trainees are being encouraged to support audit projects with a view to generating research projects locally in the long term. Support CRN SWP Research Registrar Dr David Tucker to attend British Society of Haematology Annual Scientific Meeting. CRSL and RDM to ensure NIHR research agenda is promoted at monthly Spr training days. CRN SWP Research Registrar to develop network wide audit work amongst this training group. Q4 Q1-4 CRSL to review opportunities for Spr s to work as co-investigators and PI s on the haematology portfolio to encourage greater participation. Q Health services Measure: A: Number of LCRNs with a lead for Health Services Research; B: Identification of Health Service Research studies on 25

155 LCRN Annual Delivery Plan 2017/18 research the NIHR CRN Portfolio where the research has had an impact on clinical service delivery (impact case studies). Develop research infrastructure (including staff capacity) in the NHS to support clinical research in Health Services Research Challenge: Inability to appoint to the Health Services Research Clinical Speciality Lead despite communication with the SW CLAHRC. Identify and appoint CRSL. Q1-2 All seven regional acute trusts, one mental health trust, and SWASFT, and primary care sites have recruited to or facilitated PIC activity for this specialisation in 2016/2017. Appointed CRSL and RDM to liaise with RDM for Cluster 4 to assess staff capacity in the regional mental health trusts. CSL and RDM to review regional HSR studies within year: Models of generalist and specialist care in smaller hospitals and Trial of physical activity assisted reduction in smoking to identify impact on clinical service delivery and liaise with communications lead to highlight the benefit of engagement within this portfolio for our partner organisations and primary care. Q Hepatology Measure: Number of LCRNs recruiting participants into NIHR CRN Portfolio studies in at least three of the five main subspecialty areas (viral hepatitis, immune-mediated liver disease, transplant, non-alcoholic fatty liver disease, alcohol). Increase access for patients to Hepatology studies on the NIHR CRN Portfolio Opportunity: pipeline of commercial studies for larger sites. Challenge: limited pipeline of noncommercial studies. Also see Life Sciences and Business Development Plan (Appendix 1). Open the UK-AIH (Auto-immune Hepatitis) study at RDEFT. The study is already open and recruiting at PHNT and RCHT and will continue until Q4 2017/18 and open the Pro-Euro DILI Registry (Drug Induced Liver Injury) study in at least 3/7 CRN: SWP sites. Positive EOI from TSFT. Q1-2 26

156 LCRN Annual Delivery Plan 2017/18 Aim to increase the number of commercial studies open outside of PHNT. Currently, there is only one study outside of PHNT, aim to increase this to two studies in 2017/18 by opening HEPA 5441 at RDEFT. See Life Sciences and Business Development Plan (Appendix 1). Q Infection Measure: Number of participants recruited into Infection studies on the NIHR CRN Portfolio. Increase participation in Infection studies on the NIHR CRN Portfolio Opportunity: Strong recruitment and enthusiasm for research within all GU Medicine units in the area. SAFETXT should continue to recruit strongly until it closes in March Submit sites to submit EOIs for suitable IDM studies with the objective of opening at least two studies in three sites. Q1-4 Challenges: Very limited study availability outside of GU med and low numbers of patients with HIV in region to attract available studies. Opportunities: A very engaged local GU med clinical community who have embraced the opportunity to be involved with suitable studies and would like to participate further. 17 Injuries and emergencies Measure: Recruitment via Ambulance Trusts to two or more pre-hospital care studies on the NIHR CRN Portfolio, led by Injuries and Emergencies, in each LCRN Increase participation in pre-hospital studies via Ambulance Trusts Opportunity: Research ready and experienced ambulance Trust team who have also sponsored studies. Challenge: to continue recruitment to studies once AIRWAYS II is completed. The South West Ambulance Foundation Trust continues to sponsor and deliver the AIRWAYS II study. This study is due to complete recruitment in Q2 and is currently recruiting to time and target across the South Western Ambulance Service NHS Foundation Trust, East of England, East Midlands and Yorkshire Ambulance Service Q1-2 27

157 LCRN Annual Delivery Plan 2017/18 NHS Trusts. It is planned to complete recruitment end 2017 with a target of 9000 participants. Recruitment in 2017/18 will be maintained by opening the following studies: ERA (Electronic Records in Ambulances) an observational study with paramedic crews using electronic records in ambulances. Target 80 over 12 months. HOMEWARD Phase 1 (Home or Hospital for people with dementia and one or more other multi-morbidities) which will recruit at SWASFT and EEAST collecting PCR data (non-consenting study) on 2000 incidents. EPICC (Enhancing Post-injury Psychological Intervention and Care) Stage 1.Target 48 over 3 sites including SWASFT. SWASFT is utilising funding to work with a Care of the Elderly physician on a sessional basis to develop collaborative projects in this important ageing population. The network will support delivery of the regional CI project NO-PAC (Novel use of Tranexamic Acid to Reduce the Need for Nasal Packing) which will open at 10 sites, including 5 CRN: SWP sites (YDH, TSFT, NDHT, RDEFT and PHNT). The study will recruit 450 patients over 18 months. Q1-3 Q1-2 Q1-2 Ongoing Q Mental health Measure: Increase the number of studies recruiting participants aged 16 years or under 28

158 LCRN Annual Delivery Plan 2017/18 Increase participation in Mental Health studies involving children and young people Challenge: Lack of CAMHS studies and track record of recruitment (circa 15 in past three years. available. Opportunity: Regional CI research currently two studies at grant application stage. The newly appointed CAMHS specialty lead works with Virgin Healthcare, the Devon CAMHS provider and the University of Exeter as a CAMHS lecturer. The lead will link with PhD students and staff at the UoE to assist with CAMHS research and gain portfolio adoption on current and new projects. Q1-4 First study identified for FY 17/18 AccEPT (Accessing Evidence-Based Psychological Therapies Service) Clinic for Young People (YP) and their Families. This will be a single site study based at UoE and will recruit 80 participants. Q2 19 Metabolic and endocrine disorders Measure: A: Increase the number of participants recruited into studies of rare metabolic/endocrine disease on the NIHR CRN Portfolio; B: Increase the number of participants recruited into studies of obesity on the NIHR CRN Portfolio Increase participation in studies on the NIHR CRN Portfolio relating to areas defined to be of national priority Opportunity: Local chief investigator (specialty group lead) has submitted two grant applications in 2016/17. Side-effects of Antithyroid drugs has been funded by Clinical Endocrinology Trust RfPB grant application Opportunity: Growing number of commercial obesity studies available on the portfolio and clinical interest across the region. Support local Chief Investigator alongside the Study Support Service. Ensure local sites aware of studies if awarded. To open at all SWP CRN acute Trusts Await funding decision -outcome should be available March 17. Open first Commercial obesity study META at RD&E with a target of 3 patients over the 5 month recruitment period. Q1-2 Q2 20 Musculoskeletal disorders Measure: A: Named orthopaedic champion identified in each LCRN; B: Increase the number of participants recruited into orthopaedic studies on the NIHR CRN Portfolio. 29

159 LCRN Annual Delivery Plan 2017/18 Increase engagement of orthopaedic champions to support the delivery of Musculoskeletal Disorders studies on the NIHR CRN Portfolio Challenge: Lack of Clinical Speciality Lead and orthopaedic champion Opportunity: All seven acute trusts have been MSK research active in 2016/2017 having staff capacity and capability. Interviews to appoint MSK specialty lead scheduled for Q1. Identify regional orthopaedic champion with the aim of increasing the number of patients recruited to orthopaedic studies by 10%. Q1 Q Neurological disorders Measure: Number of LCRNs that have evidenced increased early career research involvement in NIHR CRN Portfolio research. Increase the level of early career researcher involvement in NIHR CRN Portfolio research Opportunity: Whilst growth in this portfolio has previously been difficult due to a lack of new PI s, SONAR represents the opportunity to grow research active clinicians. SONAR stands for the South West Neurology Audit and Research group. It s comprised of the nine Neurology Trainees in the Peninsula Deanery. SONAR will deliver trainee led collaborative audit and research projects across the three neurology units in Devon and Cornwall. SONAR will also participate and help deliver Neurology NIHR portfolio studies. The Neurology CRSL, PD CRSL and RDM will provide opportunities and training for the SONAR group to enable and maximise NIHR research opportunities. Q Ophthalmology Measure: A: Proportion of acute NHS Trusts that provide eye services recruiting into Ophthalmology studies on the NIHR CRN Portfolio; B: The number of community based sites recruiting to Ophthalmology studies on the NIHR CRN Portfolio. Increase NHS participation in Ophthalmology studies on the NIHR CRN Portfolio Challenge: Lack of suitable studies to open in secondary care - current patient population to be found in primary care. Opportunity: Strong GP engagement with commercial trials, so ophthalmology trials can be considered outside of secondary Identify studies that can be opened in CRN SWP sites with the objective of submitting at least one EOI from four Trusts and opening two studies. Consolidate links with the regional ophthalmology trainee network (SORD) with the objective of establishing membership, launching Q1-4 Q4 30

160 LCRN Annual Delivery Plan 2017/18 care the group and starting to develop projects within the group by Q4. Develop links with Primary Care sites with the objective of submitting at least three EOIs for industry studies, and opening at least 2 sites. IOM and CRSL to develop a strategy to engage with industry; to focus on macular degeneration (wet/dry) and potential for CIs. Q3 Q3 23 Oral and dental health Measure: A: LCRNs to work with their Local Postgraduate Dental Deaneries to promote research awareness and training in their postgraduate dental communities; B: Increase the uptake of dental practitioners completing the NIHR online Dental GCP training course To increase research awareness in the dental community and increase the research-trained workforce Challenge: Lack of NIHR oral and dental portfolio Opportunity: Production of the NIHR online dental GCP training. Opportunity: Dental School to host the biannual conference of the British Society for Oral and Dental Research in Q.3 Work with Industry Operations Manager to identify future opportunities to support research delivery in collaboration with Wrigley's Oral Healthcare Programme and their appointed CRO Webbers Hardwick. RDM to contact Regional Principal Dean for Dentistry Higher Education to identify potential opportunities to promote research awareness and NIHR on-line training opportunities to foundation dentists. Q1-4 Q1 Link with the regional training schools to identify potential opportunities to promote research awareness in dental nurse and dental hygienists training. Q4 31

161 LCRN Annual Delivery Plan 2017/18 10 dental practitioners to undertake online dental GCP training. Q4 Oral and Dental Clinical Research Specialty Lead will chair British Dental Society event in Q3, this event will provide an opportunity to raise research awareness within the regional dental community. RDM to liaise with communications lead to identify 1 dental practitioner to highlight their work within dental research Q3 Q Primary care Measure: LCRNs to identify and fund a minimum of two named individuals in a GP registrar/first Five nurturing role to undertake Research Champion activities. Increase engagement of GP registrars and First Five GPs with NIHR CRN Portfolio research Opportunity: Successful regional experience of the development of collaborations between clinical specialisations and primary care to host GP registrars and First Five GP s in Identify two named clinicians to lead on the GP registrars and First Five GP s nurture project and develop project plan to host two placements in first year. Q1 CRSL and CSL to liaise with regional medical deaneries to discuss the possibility of providing face-to-face or online GCP training within core training days for GP trainees. Q1 25 Public health Measure: A: Number of LCRNs with a lead for Public Health; B: Number of LCRNs recruiting to at least one study on the NIHR CRN Portfolio led by Public Health. Develop research infrastructure (including staff Challenge: Lack of Public Health Speciality Lead Appoint Public Health Speciality Lead. Q1 32

162 LCRN Annual Delivery Plan 2017/18 capacity and working with local authorities) to support research in Public Health Opportunity: A local chief investigator will be relocating to a GP practice within the most deprived ward in Plymouth and has expressed interest in undertaking research relevant to deprivation and complex needs. The Homeless Outreach Service will also be moving to the same practice. Opportunity: Engagement of local public health trainees to embed research and support delivery. CRSL, RDM and Senior Research Nurse to visit practice of relocating CI to identify research capacity and capability and how best to support research growth. Open one study employing this strategy and facilitate delivery utilising the Clinical Support Team if community/primary care areas do not have existing research infrastructure. Q1-2 Q Renal disorders Measure: Number of LCRNs with at least 2 New PIs (defined as researchers who have not engaged as PI in any commercial study in the last 3 years) Increase the number of 'new' Principal Investigators (PIs) engaged in commercial Renal Disorders studies on the NIHR CRN Portfolio Challenge: limited commercial renal portfolio and limited capability in the region to take on commercial renal work. There are currently eight PIs with commercial experience. RD&E have two open studies, others are in follow up.. Very unlikely to develop new commercially active PIs in 2017/18 Specialty lead to review opportunities to develop new PIs as commercial trials are developed and to attend Industry Symposium at the Renal Association. Ensure new the two new Consultants at RD&E are GCP trained and assisting on NIHR portfolio research to build experience. Q1-4 Q4 Opportunity: Region has commercial trial experience within Renal research. 2 commercial trials in set up (Otsuka and Pro2tect Conversion) Facilitate annual regional renal research meeting following national specialty renal meeting to disseminate information regarding new studies with a view to opening more sites and exploring collaborations with dialysis unit. Q3 33

163 LCRN Annual Delivery Plan 2017/18 RD&E to increase collaborative working partnerships with private service providers in South Molton & Taunton. Service level agreements to be prepared. Q2 27 Reproductive health and childbirth Measure: Proportion of acute NHS Trusts, which provide maternity services, recruiting into Reproductive Health and Childbirth studies on the NIHR CRN Portfolio. Increase the proportion of NHS Trusts recruiting into Reproductive Health and Childbirth studies on the NIHR CRN Portfolio Challenges: Lack of high recruiting and other studies open in the region which despite effort has not been offered studies and does not have any local CIs. Challenge: Lack of visibility of Midwife Champion role in POs. Challenge: Lack of engagement of clinical staff to enable 24/7 recruitment Opportunities: Enthusiasm to form a trainee-led audit and research group Early expressions of interest to open three smoking in pregnancy studies have been submitted: E-Cig Trial, Pregnancy Lifestyle Survey and MiQuit Study that should open at PNHT, RDE and YDH. Establish links with the University of Plymouth Midwifery teaching faculty and provide educational sessions to student midwives about the NIHR and NIHR studies. Midwifery Champion to meet Heads of Midwifery at all regional providers to promote NIHR research and current and potential studies. CRSL to engage actively with the regional Educational meetings to raise the profile of research with the consultants. Q4 Q4 Q3 Q2 Midwife Champion to develop study specific system/ toolkits for at least two studies with local teams to support recruitment on busy labour wards with the objective of meeting target for 80% of labour ward studies open in CRN SWP sites. Q3 34

164 LCRN Annual Delivery Plan 2017/18 CRSL to support the development of a traineeled audit and research group with the objective of establishing membership, launching the group and starting to develop projects within the group. A lead trainee has been identified. Q4 28 Respiratory Disorders Measure: Number of LCRNs recruiting participants into NIHR CRN Portfolio studies in at least three of the four main respiratory disease areas (asthma, COPD, bronchiectasis, rare diseases (e.g. pulmonary hypertension, cystic fibrosis, lymphangioleomyomatosis, pulmonary alveolar proteinosis). Increase access for patients to Respiratory Disorders studies on the NIHR CRN Portfolio Opportunity: Population with above national average chronic respiratory disease prevalence. Opportunity: engaged and experienced research teams in both primary and secondary care. Challenge: Limited pipeline of noncommercial research studies. IOM and RDM will work with Boehringer Ingelheim to identify studies in Interstitial Lung Disease which will use a new integrated model of collaboration between RDEFT and TSFT to deliver studies across a wider geographical area. CRSL, RDM 5 and IOM will develop a targeted approach to appropriate primary care practices and link these with industry to enable opportunities for new research, utilising local data analysis on respiratory sub specialties and matching with population needs of the region. Q1-4 Q1-4 To recruit patients into 3 of the 4 main respiratory disease areas: Asthma, COPD, Bronchiectasis and rare disease such as Interstitial Lung Disease. Q4 This will be achieved in 7/7 Acute Trusts via recruitment into the EMBARC (European Bronchiectasis Registry) and/or the COPD Care Bundle Study. Following successful recruitment to the TWICS study by both acute Trusts and GP practices in Q4 35

165 LCRN Annual Delivery Plan 2017/ /17, we will work with the TWICS team to open the BICS (Bisoprolol in COPD study) in Stroke Measure: CRN recruitment as a % of SSNAP-recorded admissions. CRN recruitment to Stroke RCTs should be at least 8% of the 2016/17 Sentinel Stroke National Audit Programme (SSNAP)-recorded hospital admissions Challenge: Closure of local CI study Promote at the end of FY16/17, which has contributed 1522 recruits over the last 2 years for the SWP and greatly contributed to the success of this portfolio. There are currently no large scale studies to replace Promote. Challenge & Opportunity: The Cardiovascular Strategic Clinical Network has conducted a review of all stroke services in the South West and is now working with NEW Devon CCG and the major providers in Devon on proposals for the reconfiguration of hyperacute stroke services within the county, and a number of options are being considered before public consultation. Most options involve a rationalisation to fewer stroke centres, although under all configurations activity in Plymouth will remain largely unchanged. This has the potential to adversely affect research activity to some extent. Conversely, at present most hyperacute stroke research is confined to Exeter, which is likely to grow in activity to the point where an application for additional support as a Hyperacute Stroke Research Centre would be viable and SSNAP data is yet to be published for FY 16/17. However FY 16/17 there were 4287 admissions across 7 SWP centres. This would equate to 343 recruits to meet the 8% target. Historical performance is suggestive that this target will be met. Present pipeline includes CONVINCE, MAPS-2, ELAN, SOSTART and MAGIC, although not all of these studies will be funded or adopted. The network has early engagement with all study sponsors and submitted early feasibility from SWP sites. Q1-4 36

166 LCRN Annual Delivery Plan 2017/18 appropriate and YDH is likely to be a provider for a larger area and therefore will have potential for greater recruitment. 30 Surgery Measure: A: Number of LCRNs recruiting into at least 12 of the 14 surgical subspecialties (breast, cardiac, colorectal, general, head & neck, hepatobiliary, neurosurgery, orthopaedics, plastics and hand, transplant, trauma, upper GI, urology, vascular); B: Number of LCRNs recruiting at least 1 patient/100,000 population into at least 6 of the 14 surgical subspecialties. Increase patient access to Surgery research studies on the NIHR CRN Portfolio across the breadth of the surgical subspecialties Opportunity: There are currently two Chief Investigators within the specialty. Challenge: the appointment of sub specialty leads which reflect areas of both activity and potential within the region. To consider the appointment of a subspecialty lead for breast surgery to support the CRSL. Currently have sub specialty leads in; Colorectal, Urology, Trauma and Orthopaedics, General, Plastics and Vascular surgery from three acute Trusts (YDH, TSFT, RDEFT). To increase the number of local Chief Investigators from 2 to 3 by supporting the Hip- Frac study to achieve a successful grant application. Q2 Q2-3 All 7/7 acute hospital teams will continue to recruit to at least one portfolio study. Q1-4 Section 4: LCRN Operating Framework Indicators Please complete Table 4 with details of local plans to ensure compliance with the following 2017/18 LCRN Operating Framework Indicators, adding additional rows to the table where necessary. Table 4: Compliance with LCRN Operating Framework Indicators 2017/18 3 Indicator Compliance plan Timescale 3 Note: the LCRN Operating Framework Indicators 2017/18 may be subject to change following the DH annual review and approval processes for 2017/18 37

167 LCRN Annual Delivery Plan 2017/ LCRN has an identified Lead for each CRN Specialty Justification for intentional vacancies or expected timeframe to fill any vacancies in local leads for the 30 CRN Specialties: 2.3 Each LCRN provides evidence of support provided to their Local Specialty Leads (LSLs) to enable them to undertake national activities in respect of commercial early feedback and non-commercial adoption 5.2 Each LCRN has a defined approach to communications and action plan aligned with the national communications strategy 5.5 The LCRN has collaborative work PPIE plans across CRN and partners with measurable outcomes for delivery of learning resources Musculoskeletal = interviews scheduled for April Public Health = CRSL has identified clinician who has expressed interest in applying. Vacancy to be re-advertised in Q1. 3. HSR = CRSL has identified clinician who has expressed interest in applying. Vacancy to be re-advertised in Q1. All CRSLs are provided with support for their time as well as RDM and other administrative support to enable them to undertake national activities in respect of commercial early feedback and non-commercial adoption as requested by the national CC. If the national CC were to express any local leads were not able to support such activities the divisional CRL would ensure this is made available. CRN SWP Communications Lead (0.8 WTE) is in post and reports directly to the COO. Communications & PPIE (engagement) work stream implementation is supported by a WTE administrator line managed by the Communications Lead. A non-pay budget is allocated for engagement/communications activities. Where possible sponsorship is sourced to reduce or offset costs for example event hospitality or award sponsors. The CRN SWP Communications Plan for sets out the planned communications & engagement activity to ensure full compliance with the POF requirements and to support the LCRN delivery plan objectives and national communications strategy and is at appendix 3. See PPIE work plan appendix 4. Q1 N/A N/A N/A

168 LCRN Annual Delivery Plan 2017/ Each LCRN delivers the Patient Research Ambassadors (PRAs) project 6.1 The LCRN has in place a senior leader with identified responsibility for the wellbeing of all LCRN-funded staff See PPIE work plan appendix 4. Prof Tony Woolf anthony.woolf@nhs.net N/A N/A 6.2 Each LCRN has an agreed programme of activities that engage the wider workforce to promote clinical research as an integral part of healthcare for all 6.3 The LCRN has a defined approach to developing a culture of Continuous Improvement (Innovation and Improvement) support by an action plan aligned to local and national initiatives and performance metrics 7.1 Each LCRN has a completed business development and marketing Profile using the template provided by the National CRN Coordinating Centre 7.2 The LCRN has an action plan for promoting the industry agenda aligned with the national business development strategy See Workforce Development plan appendix 5 and Communications plan appendix 3. See CI plan appendix 6 See Life Sciences and Business Development plan appendix 1. See Life Sciences and Business Development plan appendix 1. N/A N/A N/A N/A 39

169 LCRN Annual Delivery Plan 2017/18 Section 5: NIHR CRN Priorities 2017/18 The national CRN priorities for 2017/18 to which LCRNs will contribute are: 1. Deliver against the NIHR CRN Strategies 4 2. Deliver NIHR CRN Portfolio studies to time and target (HLO 2) with a specific focus on commercial contract research (HLO 2A) 3. CRN Digital Programme 4. Maximise the use of CPMS Optimise research delivery Please describe any initiatives that you plan to undertake to contribute to achievement of these national CRN priorities (not already covered elsewhere in the plan). 1. Appendices are included outlining how CRN SWP will support delivery of the NIHR CRN strategies for Business Development and Marketing strategy and Working with the Life Sciences Industry Strategy in the Life Sciences appendix 1, Information and Knowledge Strategy in appendix 7, Patient and Public Involvement and Engagement Strategy in appendix 4, NHS Engagement strategy and Communications strategy appendix 3 and Workforce Development strategy appendix Support for an improvement in study delivery which includes HLO2 continues to be under the banner of DRIVE initiative, DRIVE improvement champions will remain in post to ensure DRIVE is embedded as a way of working and is not considered a project which has an end date. The DRIVE website ( provides an overview of the project and provides a document repository for downloadable tools including Top Tips for Site Initiation Visits and achieving First Patient First Visit metrics, a recruitment planning and capacity and capability assessment tools. There are also two interactive tools on the site Are you ready to assess if teams have considered everything that needs to be done before a study opens and Back on Track to help teams identify why studies are not achieving milestones and what they might do to support better delivery. 4 Business Development and Marketing strategy, Information and Knowledge Strategy, Working with the Life Sciences Industry Strategy, Patient and Public Involvement and Engagement Strategy, NHS Engagement strategy, Communications strategy, Workforce Development strategy 40

170 LCRN Annual Delivery Plan 2017/18 Underpinning these tools is the DRIVE training package which consists of three modules, Can you do it a module which aims to support staff to undertake evidence based feasibility, Are you ready which aims to ensure a study does not open until all approvals, training etc is complete and Back on Track which supports staff to understand why a study is missing milestones and what they can do to enable better delivery. The website has already been launched and promoted at a regional event and via the CRN: SWP newsletter, ongoing promotion of the site will be ongoing. The training package has now been delivered to >300 staff. Evaluation is being undertaken in March 2017 and the package will be revised accordingly. Analysis of confidence in multiple delivery aspects is reported as improved, satisfaction with the course delivery and content is high and RTT has improved. 3 & 4. See Digital plan appendix 7. Section 6: Other local innovation and initiatives Project/Initiative Identified outcome Lead Timescale Consent to contact. Opt out of research in place for Trust leading to more robust CFT Q1 feasibility and increase in recruitment Implement UK CRIS Increase in recruitment and study numbers. DPT Q2 NDDH Ophthalmology team to developing Open one IIT ophthalmology study NDDH Q4 collaboration with Plymouth University to develop Industry Funded Investigator led projects. Development of a process to capture completed Increase in number of commercial studies. PHNT Q1-4 data sets in closed studies as an additional metric to RTT to demonstrate the quality of delivery to potential commercial partners. Provision of Special Studies Unit (SSU). RCHT will provide 35 medical students across the academic year with a three week programme within the research directorate under the guidance and supervision of both the research director and lead nurse. The first day of the Students will take an active role in recruitment and delivery of portfolio studies and finish their programme with a high level of understanding of NIHR research delivery. Long term goal is to develop PI s for the future; short term goal is for research teams to benefit from extra clinical input boosting recruitment and relieving current PI s of research work load, enabling RTT metrics RCHT Q1-4 41

171 LCRN Annual Delivery Plan 2017/18 programme will deliver classroom based GCP and consent training enabling students to link directly with individual specialty teams and take an active role from day 2 of their programme. Mentorship and supervision will be provided. Create Cystic Fibrosis Clinical Trials Accelerator post in conjunction with CF trust. Work with Somerset Research Collaboration (acute and community trust partnership) to offer broader resources and experience to potential sponsors with a focus on Diabetes and Dementia studies. Provide funding (Trust RCF) to support work with an acute Trust Care of the Elderly physician to develop collaborative projects in this important ageing population. Research / Clinical Trials videos Collaboration with Royal Devon and Exeter to deliver respiratory studies. Joint funded PhD with Bournemouth University re older persons care 3 days PhD and 2 days in YDH. to be met and opportunities for existing PI s to open more studies. The SSU will also place RCHT in a prime position to successfully deliver high number snap type studies when available. Development of Paediatric CF co-ordinator post to increase the number of CF studies in the portfolio Increase recruitment and the number of studies being delivered collaboratively. Identify questions of clinical importance which the providers can collaborate on to deliver further research opportunities and submit potential grants for funding. Evaluate the Clinical Trials films project with Quintiles and to consider supporting use of these films with local CIs and generic films for multi-centre studies; Look at scope for wider marketing use within NIHR, region and Quintiles; To look at a suite of videos for education, training purposes as well as for improving staff and patient engagement; New generic video to be shown within organisation and on website; Videos of interviews with different stakeholders Collaboration agreement and study specific recruitment and funding distribution plans To commence Sep 2017 and aims increase profile of Nursing research within the Trust and aim to get study adopted onto NIHR portfolio. RDE Q2 SomPar Q4 SWASFT Q1-4 TSDFT Ongoing TSFT Q4 YDH 4 years 42

172 LCRN Annual Delivery Plan 2017/18 Section 7: Financial Management 7.1 Please describe clearly and in appropriate detail the local model for allocation of LCRN funding for 2017/18 The CRN: SWP allocation model includes top slice for certain elements, proportional allocation based on performance and the allocation of certain funds to support key strategic objectives in relation to recruitment and delivery performance. A comprehensive breakdown is provided in Appendix 7. Source data for ABF was ODP for the ABF years Q Q The model was reviewed, options appraisals undertaken and agreed by a funding model review group made up of key stakeholders as described in appendix Describe the arrangements within the LCRN Host Organisation for financial management of the CRN funding The Host employ a full time management accountant to manage the LCRN budget supported by a more senior management accountant and the CRN: SWP Chief Operating Officer. Monthly budget meetings are held. The Management Accountant is a member of the Operational Management Group and attends all meetings to support monitoring of activity against the allocation and use of resources. The Management Accountant will meet monthly with RDMs in 2017/18 to review delivery output against resource allocation to inform more comprehensive analytics of return on investment. 7.3 Describe arrangements for supporting LCRN Partners in their financial management of LCRN funding Guidance on preparing the annual finance plan and entering data in the NIHR finance tool is provided to Partner Organisations (PO s). The full time Host Management Accountant is available to Trusts to support ad hoc queries. As guidance is issued by CRN CC this is disseminated to POs. 7.4 Please provide details of any plans that you anticipate impacting on the local model for allocation of LCRN funding for 2018/19 The local funding model will again be reviewed by a regionally convened group with representatives from the LCRN, Host and Partner Organisations. It is likely this group will make recommendations that impact on the funding allocation which we will not seek to presuppose. Given a decrease in funds for the third year, it is likely based on discussions to date that work will be undertaken to review how to continue to grow activity with continued decrease in funds; minimum allocations to support continued follow-up and recruitment activity as well as how to continue to support and mechanisms to better capture and describe activity. 43

173 LCRN Annual Delivery Plan 2017/18 Appendices 1. Life Sciences and Business Development Plan 2. Matrix of responsibilities 3. Communications Plan 4. PPIE plan 5. Workforce development plan 6. CI plan 7. Digital plan 8. Profile map 9. CRN SWP Funding principles 2017/18 44

174

175 Appendix 1 CRN SWP Life Sciences and Business Development Plan 2017/18 Goal Objective Activity Lead Time scale Investigate root 1.1 Work with Partner Organisations to continue to analyse root cause analysis for IOM/RDMs Q1-4 causes for lack of closed studies, not met projected recruitment goal; develop case study examples to predictability and provide learning and improvement in delivery of studies. reliability in research delivery across the 1.2 Identify relevant specialty areas and support Partner Organisations in the IOM/RDMs Q1-4 NIHR CRN and incentivisation of PIs and growth of CIs by utilising commercial income and CRN explore how data can performance income. play a part in resolving 1.3 Identify with regional clinical leadership to identify non-medic PIs and work with Q1-4 this Deliver research with quality, predictability and reliability, benchmarked against global best performance Understand and implement systems and plans to better use data to deliver robust services Describe CRN s role in ensuring quality in research delivery industry to promote suitable studies. 1.4 Improved use of LPMS (EDGE) functionality within Primary and Secondary care to support delivery and performance of the commercial portfolio. Offer defined training to maximise functionality (see Workforce Plan Appendix 5). 1.5 Develop a merged data set between ODP and LPMS in order to provide a comprehensive integrated reporting framework for the LCRN. 1.6 Review of local feasibility service to ensure regional intelligence on population, deprivation data and disease prevalence/incidence data is used appropriately to drive the service. 1.7 Deliver successful implementation of TriNetX across 5/7 Acute Trusts providing a leading-edge health informatics solution that provides researchers with superior feasibility and cohort analytics / trial design tools. 1.8 Work with Quintiles Prime Site Manager on delivery of research within primary care. Supporting GP practices in robust feasibility, set up and delivery utilising the LCRN IOM and CST. 1.9 Develop bespoke local information package for Med Tech and SMEs for successful set up and delivery of studies (working with other key stakeholders such as CTUs, CRFs, and Universities etc.). IOM/ RDM D5 BIU/WFD Lead BIU Q1-4 Q1 IOM Q1-2 IOM Q1-2 IOM Q1-4 IOM Q1 Appendix 1 Life Sciences and Business Development Plan 2017/18 Page 1 of 4

176 1.10 Review analysis of Industry Survey (undertaken in Q4 16/17) to provide opportunities for learning; working with Lead Research Nurses and R&D Managers to improve and understand specific quality issues. IOM/BIU Q Attend, present and facilitate partnerships with SWAHSN, Business South West and regional groups to raise awareness of services offered and impact of commercial clinical research. IOM Q Develop an online resource for regional life sciences offering med tech advice, data repository (infographics, deprivation/demographics, disease prevalence and incidence, BIU tools on Capacity/Time and Motion) local impact stories, to include input from industry, key local and national initiatives etc. inform industry/smes and other local stakeholders of our capabilities. (See Communications Plan Appendix 3). IOM/ Comms Lead Q1-2 Provide services and capabilities that embrace and are adaptable to new technologies and methodologies Define and develop training on new technologies/ methodologies with Workforce Development 2.1 Liaise with key industry partners to develop a strategy for workforce skill mix to ensure we remain able to deliver studies using new measures and methodologies. Provide feedback to the Workforce Development Group. 2.2 Develop a business intelligence strategy to support the national biosimilars project to include: Undertake business analysis to identify key stakeholders and generate a roadmap for biosimilars in the local region. IOM Q1-4 IOM Q2 Create an e-learning package to introduce biosimilars and biosimilar research to healthcare professionals. Working with Communications and PPIE Leads to raise awareness of biosimilars within targeted local patient populations. Develop existing relationship with Sandoz on their pipeline in MSK, Gastro and Dermatology and link with regional clinicians to develop further. 2.3 Identify clinicians in training posts to support early feasibility audits with the aim of developing local CI commercial studies in partnership with two industry partners. IOM/RDMs Q Work with commercial partners to identify and cultivate five clinicians across primary and secondary care with an interest in taking on commercial chief investigator roles. IOM/ RDM D5 Q1-4 Appendix 1 Life Sciences and Business Development Plan 2017/18 Page 2 of 4

177 Recognised globally as a valuable assets to UK and international customers, providing a gateway to Europe and the rest of the world Continue to improve and sustain research delivery performance through key performance indicators Work with Business Development, Communications and NOCRI to present a cohesive, value add research delivery service to all sectors of the life sciences industry across the NIHR Use stakeholder map to strengthen strategic and operational relationships with key stakeholders around research delivery Appendix 1 Life Sciences and Business Development Plan 2017/ Continued implementation and review of the DRIVE project training package and dissemination of tools to support a sustained improvement in delivery performance. 3.2 Work with CRN SWP IT/IG Group to highlight new digital technologies, innovations required for study delivery and to support Partner Organisations in their implementation. 3.3 In collaboration with the SW AHSN create an IS Platform to facilitate greater access to data and training opportunities for high quality system analysis and interpretation to increase capacity, knowledge and skills and to support new research methodologies and robust feasibility. 3.4 Open dialogue between the local SME community and partner organisations to develop a delivery plan for new medical technologies, including medical devices and IT infrastructure. 3.5 Attend Quintiles Prime Site Executive and Operational meetings and work with the Quintiles team to improve study delivery and develop new ways of working across the region. 3.6 Work with industry partners to develop new local collaborations in respiratory medicine, cardiology, and ophthalmology to facilitate new ways of working providing patients with wider access to commercial clinical trials: one new study in each area to be selected in year. 3.7 Create a strategic collaboration with external organisations such as Bloomsbury Innovation Group, Medpreneur, and Crick Industry Route Partnership to ensure continued growth by promoting and fostering new research collaborations. 3.8 Develop joint working projects between LCRN, Partner Organisations, and Industry reflecting population needs of the region using demographic, deprivation, and Atlas of Variation data. 3.9 Work with local investigators to develop a strategic plan to support national interests in the delivery of biosimilars studies. To ensure greater availability of these drugs for patients Undertake a local stakeholder analysis to identify key current and potential stakeholders in the life sciences domain. This will highlight areas in which resource needs to be invested to ensure continued, appropriate, growth. Initial stakeholders identified include Becton-Dickinson (forging new CI led research across primary and secondary care), Intercept (hepatology) and Sandoz (biosimilars) Based on analysis of the local population a gap has been identified in the diabetes and endocrine portfolio in primary care. To address this we will invite a Page 3 of 4 COO/BIU Q1-4 IOM Q1-4 IOM Q1-3 IOM Q1-4 IOM Q1-4 IOM Q1-3 IOM Q1-4 IOM/BIU Q1-4 IOM/CRLs Q1-2 IOM Q1-4 IOM/ RDM D5 Q1

178 opportunities locally and nationally Develop network expertise and cross stakeholder working within these new stakeholders Novo-Nordisk representative to deliver a pipeline summary at a local primary care event to foster improved working relationships and raise the profile of commercial opportunities Maintain, analyse, and utilise a key contacts list for all regional life sciences partners to include medical/bio-technology companies, local Chambers of Commerce, Universities, Business South West, regional ABPI and other key stakeholders Following links with local Vanguard sites (South Somerset Symphony Partnership) in Q4 16/17, collaborate with industry partners to promote and provide opportunities for greater access to research for the region shaping patient pathways and aligning with the needs of the population and identify new digital technologies to support access and delivery; to bring specific patient profiles into the recruitment process. 4.5 Work with the SW AHSN on the delivery of the SME innovation pathway to ensure the region is competitively placed to undertake research with SMEs. Following SME/Med Tech mapping within the SWP, facilitate dialogue with innovators with the aim to secure faster access to the NHS market and better value, by data intelligence and mapping (horizon scanning, data on impact of technologies on patient outcomes), local support for the adoption of innovation to foster stronger incentives for local Partner Organisations to use and spread the benefits of innovation. 4.6 Work directly with the SBRI South West Link to engage with SMEs applying for funding to ensure research is incorporated into applications leading to successful regional delivery of studies. Attend meetings led by SWAHSN on SBRI calls for funding to raise profile and link with regional clinicians for potential joint submissions with SMEs. 4.7 Continue to work with SWP Community Pharmacy Lead to engage and develop commercial PI roles, support delivery of current and emerging portfolio and utilising pharmacy data for robust expression of interest submissions. Creation of infographics to promote activity and opportunities to industry. 4.8 Work with industry partners to develop a programme to support the development of local pharmacy CI expertise. IOM Q1-4 IOM Q1 IOM Q1-4 IOM Q1-4 IOM/BIU Q1-4 IOM/ Pharmacy Lead Q1 4.9 Support RSI sessional practices to set up a professional group to develop research questions with the aim of getting one study to feasibility stage. IOM/RDM 5 & Primary Care Lead Q1-4 Appendix 1 Life Sciences and Business Development Plan 2017/18 Page 4 of 4

179 Clinical Research Network South West Peninsula Appendix 2 RESEARCH DELIVERY Study Support Services Responsibility Matrix for non-commercial multicentred studies Pauline McGlone Version 2.0 For Consultation in Use 1

180 Appendix 2 Clinical Research Network South West Peninsula GLOSSARY BIU Business Intelligence Unit CC Co-ordinating Centre CI Chief Investigator CLAHRC Collaboration in Leadership in Applied Health Research and Care CRN Clinical Research Network CRSL Clinical Research Specialty Lead CTU Clinical Trials Unit HEI Higher Education Institute PIC Patient Identification Centre PO Provider Organisation PPIE Patient and Public Involvement and Engagement RDM Research Delivery Manager RDS Research Design Service SBRI Small Business Research Initiative SOE Schedule of Events SSS Study Support Service SoA Statement of Activities Version 2.0 For Consultation in Use 2

181 Appendix 2 Clinical Research Network South West Peninsula The Clinical Research Network (CRN) Study Support Service spans the research pathway (see below) and should be provided to all potentially eligible National Institute of Health (NIHR) CRN studies including those that involve Small and Medium Size Enterprises (SMEs) and funding streams such as the Small Business Research Initiative (SBRI) and investigator initiated trials (those funded by industry but sponsored by NHS or Higher Educational Institutions) (HEIs) which are treated as non-commercial studies. Some sponsors may delegate responsibilities to CTUs so the involvement of the CTU will vary on a study by study basis and so is included in sponsor activity. The CRN: SWP have created the Responsibility Matrix in Table 1 to highlight the activities and responsibilities for each of the different stages. The CRN: SWP devolve some responsibilities for the Study Support Service to the Partner Organisations and this matrix outlines the specific tasks that are devolved, shared or provided by the CRN core team for multi-centred studies. The matrix should also be followed by the main NHS site for single site studies. This will ensure that there is support and consistent advice for studies that are eligible for CRN support and for single site studies to also access support from the central CRN team where required e.g. Communication s Lead for digital technologies and social media. Research ideas Stage1 Stage 2 Stage 3 and stage 4 Study Development Study set-up and Study recruitment/ and planning start up Follow-up Study Closure Version 2.0 For Consultation in Use 3

182 Appendix 2 Clinical Research Network South West Peninsula Table 1: Responsibility matrix for delivery of the CRN: SWP Study support service Stage 1 Research ideas and study development and planning Pre grant award Study Support Service Component and link to national SOP and tools Providing expert guidance for inclusion in grant applications or protocol development on delivery of a study in the NHS Early Contact and Engagement with researchers SOP ihr.ac.uk/nihrcrnstudysuppo rtservice/home/preapplication-support Activities Do-ability in the NHS Analysis of the healthcare system and Quality and Outcomes Framework (QOF) data analysis on numbers of patients with disease prevalence and analysis of other data sources; Advice on treatment intervention deliverability in the NHS Advice on effective recruitment strategies including digital technologies and Core CRN team RDM CRSL BIU team Study Support Service Co-ordinator RDM RDM CRSL Responsibility Devolved R&D Teams Other RDS RDS Sponsor RDS Version 2.0 For Consultation in Use 4

183 Appendix 2 Clinical Research Network South West Peninsula communications Advice on types of sites PIC/ main site/subsidiary sites Communications Lead BIU team Study Support Service Co-ordinator RDM CST BIU team Sponsor Portfolio eligibility advice Trust R&D Sponsor Support on portfolio eligibility Study Support Service Co-ordinator Signposting - Patient and Public Involvement and Engagement PPIE administrator Site identification multi centred studies Costing of grant submission (all research and NHS costs - treatment and service support costs) Study Support Service Co-ordinator RDM Trust R&D National Co- Ordinating Centre (CC) Sponsor Version 2.0 For Consultation in Use 5

184 Appendix 2 Clinical Research Network South West Peninsula Costing of primary care NHS Costs/Treatment costs and SSCs Cost attribution (Research, ETC, SSC) Study support Service Co-Ordinator CST Trust R&D AcoRD expert Sponsor Cost attribution primary and community sites Cost attribution advice and support Study Support Service Co-ordinator CST Study Support Service Co-Ordinator Final review of all costs prior to submission Sponsor Version 2.0 For Consultation in Use 6

185 Appendix 2 Clinical Research Network South West Peninsula Stage 2: Study set up and start up post grant It is essential to have a joint meeting organised by the study sponsor/study Support Service Co-ordinator involving all parties CI, sponsor, CTU, Partner Organisation NHS R&D department for main NHS site, RDM and CRSL, where required. This joint meeting will agree the activities, responsibilities and timelines for submission for regulatory approval and prompt study set up and will include advice and support and dissemination of information to participating sites. Stage 2: Part A Study Support Service Component, link to national SOP and tools National CRN Effective Study Start-up SOP: ac.uk/nihrcrnstudysupportservi ce/home/effective-study-setup-processes Activities Provide early feasibility (pre-final protocol).and dissemination of early feasibility questionnaires for site identification for multi centred studies Core CRN team RDM Study Support Service Co-ordinator Responsibility Devolved R&D teams Other Other LCRNs Sponsor TOOLS Clinical Trials toolkit Establishing the CRN support which will be required to deliver the study and assisting local planning Study Support Service Co-ordinator RDMs CST Version 2.0 For Consultation in Use 7

186 Appendix 2 Clinical Research Network South West Peninsula toolkit.ac.uk/routemap DRIVE ydrive.co.uk/ Top tips for SIV Are you ready? National study recommendations and national study delivery assessment template /d/0bzk8axmyfq4xmfzzt DJCenFfZW8/view Identify /confirm site selection with study team Primary Care Feasibility Review of costings and completion of the appropriate costing templates ETCs; non-commercial CRN: SWP costing template, research costs information for sites Completion of primary care costings research/etcs/sscs Dissemination of cost attribution and ETC information and appropriate templates to participating sites through the study recommendations or earlier if required ETCs submissions to CCGs Study Support Service Co-ordinator RDM Cluster 5 RDM CST Study Support Service Co-ordinator CST Study Support Service Co-ordinator Trust R&D Trust R&D Chief Investigator Participating LCRNs/RDMs Sponsor CCGs NHS England Participating sites Version 2.0 For Consultation in Use 8

187 Appendix 2 Clinical Research Network South West Peninsula Escalated problems with ETCs Advice on potential recruitment pathways (Subsidary Sites/ Continuing Care Sites, PICs.) Advice from Clinical Support Departments (Pharmacy medicines management, Medical Exposure, pathology and other Laboratories) Advice and signposting regarding regulatory approvals including HRA approval and research management Identifying training requirements for the study Supporting study walk identifying patient to support this where appropriate Study Support Service Co-Ordinator RDM Study Support Service Co-ordinator RDM PPIE Administrator Trust R&D Clinical Support Departments Trust R&D Sponsor Sponsor Sponsor Sponsor Schedule of events (SOE) for each site type Advice and support on cost attribution of the SOE Study Support Service Co-ordinator Trust R&D AcoRD expert Sponsor Version 2.0 For Consultation in Use 9

188 Appendix 2 Clinical Research Network South West Peninsula Statement of activities per site type Trust R&D Sponsor Completion and dissemination of the Study Recommendations form (prior to HRA submission) Dissemination of study walk throughs ; recruitment planning toolkits, and other associated support to facilitate set up and RTT to participating sites Disseminating portfolio eligibility decisions to participating LCRNs Advice and support to CIs on the Central Portfolio Management System (CPMS) and on recruitment upload Completion of study milestone on CPMS to record information regarding participating sites, recruitment targets Study Support Service Co-ordinator/Facilitator RDMs Study Support Service Co-ordinator/Facilitator Study Support Service Facilitator Study Support Service Facilitator BIU Study Support Service Co-ordinator Facilitator National CC Upload of sites onto CPMS Study Support Service Facilitator Version 2.0 For Consultation in Use 10

189 Appendix 2 Clinical Research Network South West Peninsula Data quality check on individual study information in the CPMS Study Support Service Facilitator BIU Disseminating and collating study set up metrics for CPMS to track HLO4 Study Support Service Facilitator Enter study on LPMS (EDGE) Data check on individual studies on LPMS at site level HRA submission (study level) Study Support Service Facilitator Trust R&D if sponsor National CC Sponsor Version 2.0 For Consultation in Use 11

190 Appendix 2 Clinical Research Network South West Peninsula Stage 2: Part B: National study delivery assessment (NSDA) Study Support Service Component and link to national SOP Non-commercial feasibility process: National study delivery assessment (NSDA) is combined with study recommendations 4xMFZzTDJCenFfZW8/view This aims to identify study delivery issues so that studies are RAG rated as standard, enhanced or bespoke by the Co-ordinating Centre and are then monitored according to the classification Activities Completion of the NSDA for multi centred studies through the study recommendations Tracking of NSDA Core CRN team RDM CRSL Study Support Service Co-ordinator Study Support Service Facilitator Responsibility Devolved R&D teams Other Version 2.0 For Consultation in Use 12

191 Appendix 2 Clinical Research Network South West Peninsula Stage3: Study recruitment/follow-up and study closure Part A: Performance Management Study Support Service Component and link to national SOP Study performance monitoring udysupportservice/home/apm This aims to help with performance management of studies to support time to target and activities are conducted locally and by the national co-ordinating centre TOOLs DRIVE back on track Activities Quarterly audit of data quality issues on CPMS checking for uploading of recruitment data at sites; correct mapping of sites Monthly Review of Chief investigator RTT report on ODP If study review highlights concerns arrange meeting with local CI to review performance Advice on addition of sites and SSCs and cost implications Core CRN team Study Support Service Facilitator RDMs Study Support Service Co-ordinator RDMs CRSL where required Study Support Service Co-ordinator RDMs CST Responsibility Devolved R&D teams Other Sponsor Sponsor Version 2.0 For Consultation in Use 13

192 Appendix 2 Clinical Research Network South West Peninsula Recalculation of costs ETCs/SSCs/research costs Trust R&D Sponsor Advice on new costings and resources Study Support Service Co-ordinator Recalculation of costs for primary and community care sites Study Support Service Co-ordinator CST Implement rescue plan to get study RDMs Sponsor back on track Disseminate rescue plan/new costings and other information to participating sites Study Support Service Facilitator Submission of amendments Trust R&D Sponsor Co-ordinate performance management calls with national CRN CC and other LCRNs RDMs Version 2.0 For Consultation in Use 14

193 Appendix 2 Clinical Research Network South West Peninsula Part B: Study closure Study Support Service Component and link to national SOP To ensure that recruitment is uploaded and correct. To provide feedback to local speciality groups regarding metric and trends To support CIs to disseminate research findings Activities Check recruitment upload and mapping in CPMS Complete the review study closure checklist and record reasons for study not recruiting to time and target Conduct telecon with CC and amend any incorrect information and targets Identify patients to capture patient stories of impact Core CRN team Study Support Facilitator BI Study Support Service Co-ordinator Study Support Service Co-ordinator RDM PPIE Officer Communication s Lead Responsibility Devolved R&D teams Other Divisional Portfolio Manager Sponsor Lay summary of research findings Trust R&D Sponsor Dissemination of impact to clinical Trust R&D Version 2.0 For Consultation in Use 15

194 Appendix 2 Clinical Research Network South West Peninsula directorates and CCGs Version 2.0 For Consultation in Use 16

195 Appendix 3 Communications Plan 2017/18 1. INTRODUCTION This document sets out the communications plan for the Clinical Research Network South West Peninsula (CRN SWP) for The focus of this plan is to ensure the CRN SWP fulfils the requirements of the Performance and Operating Framework (POF) with the delivery of a local communications plan in support of the national NIHR CRN NHS Engagement and Communications strategies. There are two key aspects to this plan: 1.1 Internal Communications activity to foster high levels of engagement and share best practice within the CRN SWP research community. 1.2 External Communications activity to foster relationships with valued stakeholders and partners to raise awareness of clinical research and promote opportunities for greater public and patient involvement and participation. 2. HIGH LEVEL OBJECTIVES (HLO) The top Communications and Engagement priorities for the CRN SWP in are aligned to the national key objectives set out in the NIHR CRN Communications Strategy Our communications plan will support the Network commitment to: Increase the number of participants recruited into NIHR CRN portfolio studies (HLO1) Increase the proportion of NIHR CRN portfolio studies delivering recruitment to time and to target (HLO2) Increase the number of commercial contract studies delivered through the NIHR CRN (HLO3) Reduce the time taken to recruit first participant into NIHR CRN portfolio studies (HLO5) Increase NHS participation in NIHR CRN portfolio studies (HLO6) Increase the number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN portfolio (HLO7) 3. COMMUNICATION OBJECTIVES The NIHR CRN Communications Strategy sets out the communications function for each Clinical Research Network in England. These core responsibilities are: Raising the profile of clinical research in the CRN locality Promoting the importance of clinical research with local health providers Working with local clinicians and patients to develop high quality stories about their activities and participation Participating and contributing to the NIHR communications campaigns Protecting and enhancing the reputation of the NIHR with adherence of brand identity and communications best practice and protocols Appendix 3 Communications Plan 2017/18 Page 1 of 8

196 Sharing communications activity and best practice within the Network via the Coordinating Centre Supporting and contributing to centrally co-ordinated communications including flagship publications and creative development activities. 4. LCRN COMMUNICATIONS SERVICE DELIVERY CRN PERFORMANCE OPERATING FRAMEWORK REQUIREMENT To ensure full compliance with the POF requirements the CRN SWP Communications Lead will: 4.1 Contribute to the national CRN communications campaigns (including International Clinical Trials Day, Join Dementia Research, League Tables) supporting press Releases, social media and engagement activities 4.2 Contribute and publicise 6 Our Stories of patient/staff participation in research for the NIHR CRN website and media/third party communications channels 4.3 Contribute a feature and a patient story for the Behind the stories section on the NIHR CRN website 4.4 Generate positive media coverage of two research stories 4.5 Maintain the CRN SWP web pages Attend quarterly national CRN communications leads meetings 4.7 Contribute to the development of the CRN communications service function 4.8 Adhere to and support the CRN to comply with the One NIHR brand identity guidance 5. CRN SWP COMMUNICATIONS OBJECTIVES The CRN SWP communications plan for builds on what has been achieved with the and plans. It will support the national communications objectives but it will also seek to develop local initiatives and new approaches to support our local Network business priorities in support of research delivery and wider engagement with clinical research. Internal and external communications activity embedded over the past two years will continue but the communications plan presents an opportunity to: 5.1 Deploy our communications function as a professional support service to enhance awareness of and engagement with clinical research across primary/community health care in the South West peninsula. 5.2 Deploy our communications function to support Chief and Principle Investigators with their recruitment strategies, particularly for complex studies or to reach difficult to reach potential participants. 5.3 Adopt more digital media, where appropriate and possible to use, to promote clinical research participation opportunities and raise awareness of clinical research. 5.4 With the involvement of PPIE members/representatives more closely and effectively align our Patient & Public Involvement and Engagement activity with the CRN SWP Communications function to promote our offer to supporters in the public realm and how PPIE adds value to research delivery and experience. 5.5 Promote to the Life Science community the Network research delivery capability, capacity, track record and achievements. 5.6 Raise awareness of clinical research in dentistry and oral health, as a progression of The engagement activity started last year with community pharmacists. Appendix 3 Communications Plan 2017/18 Page 2 of 8

197 6. INTERNAL NETWORK COMMUNICATION PRINCIPLES AND APPROACH To support the delivery of the local communications objectives, all CRN SWP staff members are expected to adhere to the following principles for their operational communications. Effective communication is: Planned and strategically focussed Timely, targeted and where required two-way Consistent and easy to understand The responsibility of all Tailored to effectively reach the target audience for example patient group, partner organisation, health specialty clinical staff group. In following these key principles for communications we hope to achieve: Clear consistent messaging with and external to the Network A clear understanding of the NIHR Network role/service in support of research delivery Effective high quality cascading of updates and sharing of best practice within our Network The NIHR as a single NHS branded identity Effective local support and amplification of NIHR national campaigns Pride in our presentation, accuracy and timing of communications as a reflection of the professional reputation of our CRN and the NIHR. The CRN SWP Communications and Administrative Services provides support materials, templates and guidance for core staff and Network partners on the NIHR hub. 7. STAKEHOLDERS A stakeholder is any individual, organisation or representative group with an interest in or who works with the CRN SWP or has an interest in supporting or contributing to clinical research delivery or experience. CRN SWP Internal Executive Team Lay Executive Members CRN SWP core staff team Clinical Research Leads and Clinical Research Specialty Leads CRN National team through CRN communications team CRN SWP Patient Ambassadors CRN SWP PPIE membership CRN SWP Network partners Lead Research Nurses/Practitioners Research & Development Managers Research & Development service staff within NHS Trusts Peninsula Clinical Trials Unit South West Academic Health Science Network Communications teams in NHS Trusts & Clinical Commissioning Groups South West Peninsula NHS Trusts Appendix 3 Communications Plan 2017/18 Page 3 of 8

198 South West Peninsula Higher Educational Institutions South West Peninsula Clinical Commissioning Groups leads Health Education South West South West Strategic Clinical Network Community Interest Company health care service providers Private sector health care service providers GP practices & health centres Community pharmacies Study sponsors and trial managers Industry & Life Sciences External Patients across the different healthcare settings Caregivers and families of patients Partner organisation PPIE members General public Media (print, broadcast, online & specialist) Health specialty charities Patient/carer support groups for specific health conditions Health lobby forums (for example Healthwatch) 8. RISKS The CRN SWP is mindful of potential risks which may compromise implementation of its communication plan for These are: Risk Resistance or poor engagement to research promotion or delivery by health care providers particularly with the pressures on operational services and resources. Research not regarded as an intrinsic part of quality healthcare provision. Professional gatekeepers who do not offer their patients the opportunity to take part in clinical research. Lack of awareness of patient right under NHS Constitution to be offered or given access to clinical research where appropriate for their healthcare needs. Mitigation Support the research delivery teams & management to ensure the profile of clinical research and the benefits to patients and the service/trust/organisation are known, evidenced, appreciated and shared or promoted. Explicitly state the direct correlation between quality patient care, treatment and experience informed by research. Promote key message: Research should be a norm in healthcare. Wherever possible use first-hand real local examples and testimonials by patient participants and professional peers about the benefits of taking part in trials or supporting research. Dispel myths and provide practical support and guidance to overcome barriers. Promote this right wherever possible in communications for patients and the public. Appendix 3 Communications Plan 2017/18 Page 4 of 8

199 Lack of awareness & recognition of the NIHR brand and purpose Political & public scrutiny of the social and financial return on public funding of clinical research when NHS England services under intense pressure and performance not meeting targets/standards. Consistent adherence of the NIHR brand guidance and protocols across the CRN community. Provide support materials, templates and guidance. Raise awareness about the benefits of clinical research participation for patient & public health; informing changes which save NHS funding and improve services; and driver for economic growth and reputation of UK PLC. 9. COMMUNICATIONS METHODS There are embedded CRN internal and external communications channels/tools. To ensure value for public money we pro-actively seek to use existing platforms which may be provided by partner organisations and third party stakeholders rather than duplicate by creating our version. This also is a more sustainable approach and reinforces our stance that everyone has a responsibility to communicate and promote clinical research across the CRN in the South West peninsula. 9.1 Core CRN SWP communications channels/tools Regular scheduled meetings, teleconferences, webinars & group updates for staff and stakeholders E-news bulletin for core staff (Core Team News) fortnightly in addition to the national CONNECT e-bulletin issued by central CRN communications service E-bulletin for GP practices issued fortnightly by Clinical Support Team (study & training info, PPIE opportunities & case studies, CRN SWP news and campaigns) Research e-magazine issued every six weeks to professional research delivery community across the whole network and local Members of Parliament Research e-magazine called INVOLVE for public readership. Piloted last year. Bi-annual and issued through CRN SWP & partner organisation PPIE databases. Online news, events, resources and contact information NIHR Hub for communications Standard Operating Procedures, guidance, resources & templates Annual events primary/community clinical research and Research Network Forum with awards for innovation and best practice. Community of best practice forums and events for health specialties organised by the Research Delivery Managers with the Clinical Research Specialty Leads. 9.2 Third party communications channels/tools used by CRN SWP Press releases for local, regional & specialist media (radio, television, print & online news channels) Network research delivery partner organisation (acute, mental health & community/primary care) websites, Facebook, Twitter, newsletters, digital information screens & waiting rooms displays Partner organisation events with CRN SWP information stands & speakers/workshop facilitators Appendix 3 Communications Plan 2017/18 Page 5 of 8

200 Health charities, lobby groups (Healthwatch) and patient support groups for specific health conditions. 10. LCRN COMMUNICATIONS PERFORMANCE MANAGEMENT Implementation of the CRN SWP communications plan will be monitored at regular 1:1 reviews by the COO with the Communications Lead; as well as being part of the performance appraisal for the Communications Lead. The Communications Lead has monthly teleconferences with the CRN Communications central link person to brief on forthcoming planned activities and monitor progress against POF requirements. 11. CRN SWP INTERNAL & EXTERNAL Communications WORK PLAN & Evaluation In addition to the CRN SWP commitment to the POF communications requirements ( ) and the core communications & engagement activity embedded across the Network, the following additional activity is planned to support local research delivery priorities: Strategic objective CRN SWP activity Measure of success Deadline HLO 1 Increase the number of participants recruited into NIHR CRN portfolio studies HLO 1 HLO 2 Increase the proportion of NIHR CRN portfolio studies delivering recruitment to time and to target Deploy our communications function as a professional support service to enhance awareness of and engagement with clinical research across primary/community health care in the South West peninsula. Develop the CRN SWP e-mag for public supporters of research piloted in to foster engagement and awareness of research participation & involvement opportunities. Deploy our communications function to support Chief and Principle Investigators with their recruitment strategies, particularly for complex studies or to reach difficult to reach potential participants. 100% GP practices with CRN SWP funding will have on their websites & waiting room screens consistent research information including UKCTG link or open studies information. Increase readership from 200 to 300. Evidence examples of communications support given to improved RTT. Q3 Q4 Q4 HLO5 Reduce the time taken to recruit first participant into NIHR CRN portfolio studies Adopt more digital media, where appropriate and possible to use, to promote clinical research participation opportunities and raise awareness of clinical research. Develop first digital media plan Introduce CRN SWP monthly tweets in support of studies opening & recruiting. Q1 HLO 5 Adopt more digital media, Create a CRN SWP Q2 Appendix 3 Communications Plan 2017/18 Page 6 of 8

201 where appropriate and possible to use, to promote clinical research participation opportunities and raise awareness of clinical research. Research Facebook and launch on ICT Day Target: 500 x Facebook followers HLO 5 Adopt more digital media, where appropriate and possible to use, to promote clinical research participation opportunities and raise awareness of clinical research. Provide advice & support to local CI s to apply digital media where appropriate for recruitment. Encourage & support sites to use digital & social media for recruitment & promotion (where ethics approved to do so). Q2-4 HLO 3 Increase the number of commercial contract studies delivered through the NIHR CRN Promote the Network research delivery capability, capacity and strong track record to the Life Sciences community. Create dedicated online shop window (NIHR CRN website) for life sciences and SME industries showcasing our CRN support service offer & the research delivery strengths & track record of SW sites. Q2 HLO6 Increase NHS participation in NIHR CRN portfolio studies Promote the profile of research professional roles & NIHR. This will support WFD & external awareness raising of who does research and celebrate their skills, knowledge and commitment to improving patient care and experience. Introduce a quarterly update as an online resource for life sciences and SMEs; updating on activity & success for valued and potential partners to keep CRN SWP on their radar. Localise the national CRN campaign I am research by profiling six different research staff roles and why they love what they do. This will be done in partnership with Plymouth Hospitals NHS Trust. We will generate Q2 & Q4 Q2-3 Appendix 3 Communications Plan 2017/18 Page 7 of 8

202 materials for the trust to use internally and generic version for wider CRN use to raise awareness about who does research. HLO 6 HLO7 Increase the number of participants recruited into Dementias and Neurodegeneration (DeNDRoN) studies on the NIHR CRN portfolio Promote research within dentistry and oral health Raise profile of dementia research with focus this year on primary care & dense population communities. Develop & implement a communications plan to raise awareness of research activity, expertise & opportunity to take part in studies in partnership with university medical schools. Dentistry professional community is target audience in phase 1. In support of CRN SWP target to increase % of diagnosed dementia patients registered with Join Dementia Research: implement a mini campaign for primary/community healthcare & general public in Exeter & E Devon; Plymouth and Truro to promote dementia research activity & participation opportunities. Q3 Q4 Appendix 3 Communications Plan 2017/18 Page 8 of 8

203 Appendix 4 CRN: SWP PPIE Plan The PPIE plan for 2017/18 will focus on working with our Partner Organisations (POs) to embed engagement and involvement within their organisations. The CRN: SWP will promote the Patient Ambassador Initiative and work alongside our NIHR partners to avoid duplication, work collaboratively and have a regional wide strategy to PPIE. To ensure a full review of the activities this PPIE plan should be read alongside the Communication s Plan which has a focus on the engagement activities across the region. Objective Actions Lead Timescale Talk about research in the NHS - We will help raise awareness of research by improving the availability, variety and usefulness of accessible information Make it easy for people to participate - we will work in partnership with patients, carers and the public to reduce barriers Review with POs the patients/members of the public (ambassadors) currently undertaking engagement and involvement activities and promote the patient ambassador initiative so that all organisations have an identified patient research ambassador Review skills and diversity of all PPIE volunteers (Ambassadors) on involvement databases and promote and target involvement opportunities to increase diversity where relevant Promote the newly designed induction leaflet to research ambassadors in partner organisations and promote involvement opportunities in delivery Work with patient research ambassadors to support the communication lead in developing useful and accessible information and support development of the PPIE INVOLVE Newsletter Identify 10 patients / (patient ambassadors) to attend support groups across the region to raise awareness of research opportunities Develop standardised promotional materials with patients/members of public for use by patient research ambassadors for awareness raising Develop the portfolio maps in gastroenterology, respiratory, dementia, cardiovascular and dermatology to support awareness raising of research opportunities to clinicians Target research awareness impact stories to Trust Governors and primary care Patient Participation Groups (PPGs) Develop processes for identifying patients that are referred to cancer studies across the region using the recently developed portfolio maps Review the Avon and Wiltshire Mental Health Partnership consent to contact process and implement across all Partnership Trusts in the SWP Evaluate the All practice approach to promoting research opportunity in primary care Review the findings of the 2016/17 Patient Experience Questionnaire (PEQ). Work with the PPIE Lead Communication s Lead PPIE Lead PO PPIE Leads PPIE Lead Communication s Lead Q1 Q1 Q1 Q1-4 PPIE Lead Q2-4 Communication s Lead Research Delivery Managers Communication s Lead PO PPIE Leads Div. 1 Research Delivery Manager PPIE Lead PO PPIE Leads PPIE Lead Research Delivery Manager PPIE Lead Communication s Q1-2 Q1-2 Q1-4 Q4 Q1-4 Q1-4 Q1-2 Appendix 4 PPIE Plan 2017/18 Page 1 of 2

204 Appendix 4 Trust PPIE research leads to identify areas of poorer experience and implement a plan to mitigate these. With PPIE members and Partner Organisations (PO) design and undertake a PEQ in 2017/18 and pilot the use of collecting information using a digital platforms Review training needs for involvement leads in POs and promote the use of Massive Open Online Course (MOOC) and INVOLVE resources to support development; develop regional training modules where required Embed the use of social media for involving patients in the top tips for incorporating digital in the study support service Re-establish joint working group with South West Academic Health Science Network (AHSN), Collaboration in Leadership in Applied Health Research and Care (CLAHRC), Research Design Service (RDS), NIHR Clinical Research Facility (CRF) and other potential partners to support patient and public involvement. This will be across the research pathway and will aim to avoid duplication and promote greater involvement opportunities. Create new leaflet with all NIHR partners to describe involvement, engagement and participation across the research pathway Review and list all training opportunities (including Building Research Partnerships) for patients, researchers and PPIE leads with NIHR partners and list all training through a central Pilot the use of the health and care videos for promoting research opportunity across all the acute Trust NHS organizations and evaluate their use with patients and staff Work With POs and develop online digital communities involving patients/members of the public for two specialty areas where there is a need to support portfolio growth (mental health and paediatrics Evaluate the use of volunteers who support research clinics and patients in the Torbay and South Devon NHS Foundation Trust and complete action plan for use in other organisations Collect at least three case studies on impact of patient and public involvement on study set up and delivery. Share in CRN: SWP newsletter. Demonstrate outcome of involvement through a you said we did as part of CRN: SWP PPIE newsletter Standardise the collection of involvement and engagement activity across all POs to include numbers of research ambassadors, numbers of activities supported, access to learning resources, type of activities to support the collection of information to support the PPIE and information Framework Lead PO PPIE Leads PPIE Lead Communication s Lead PO PPIE Leads PPIE Lead PO PPIE Leads Q3 Q1-4 PPIE Lead Q1-4 PPIE Lead Q1-4 PPIE Lead Q1-4 PPIE Lead Q1-4 PPIE Lead Communication s Lead PPIE Lead PO PPIE Leads PPIE Lead PPIE Lead Communication s Lead Communication s Lead PPIE Lead PPIE Lead Q3 Q3 Q1 Q1-4 Q1-4 Q1 Appendix 4 PPIE Plan 2017/18 Page 2 of 2

205 Appendix 5 Workforce Development Plan 2017/18 A key part of the CRN SWP delivery strategy has been the funding of Lead Research Nurses/Practitioners in all Acute and Mental Health Trusts and a Senior Research Nurse for Primary care. These posts support portfolio delivery by managing research delivery staff at a Trust level, ensuring workforce development and deployment. The majority of the research delivery workforce funding is devolved to Partner Organisations with staff reporting to these key clinical leaders. NIHR CRN funding is not the only source of funding for the research delivery workforce within Partner Organisations. The finance tool does not allow a full review of the workforce. It is therefore not possible to fully map the appropriateness of the skill mix across all teams; however we will continue to work with the Lead Research Nurse/ Practitioner group to assess the skill mix within research delivery teams and how this relates to staff roles. 8% of the research delivery workforce is employed under agile models with staff working across communities and organisations. There is an expectation that the agile workforce will grow over the next 12 months. Currently, a Clinical Support Team is in operation across the region supporting studies within primary care and The Devon Dementia Collaboration brings together staff from an Acute Teaching Hospital and Mental Health Trust to deliver Dementia studies. Vacancy rates identified through the Q3 finance return runs at 3% across the delivery workforce. This figure rises to 5% in Haematology and Genetics where there are fewer staff and vacancies have a more significant impact. Goal Objective Activity Lead Time scale Establish flexible workforce A review of the non-registered workforce will be WFD lead Q2 models that support undertaken and a map produced to visually research delivery across describe the research career pathway. organisational and divisional boundaries Deliver a responsive and agile research delivery workforce Scope potential for apprenticeships in nonregistered roles. WFD Lead Q2 Progress Scope a regional Research Manager development programme. Lead Research Nurse/Practitioner (LRN/P) group to review delivery staff job descriptions to ensure staff have the ability to work across boundaries. WFD Lead LRN/P s Q3 Q2 Appendix 5 CRN SWP Workforce Development Plan Page 1 of 5

206 The WFD lead is now a member of the regional primary care workforce meetings facilitated by SWAHSN; this brings together CCGs and Providers as well as NHSE, SWHEE & HEI s. This group is addressing workforce issues in primary care providers with a view to ensuring new models of workforce are developed in response to changes in the available workforce. WFD will ensure research delivery is considered. WFD Lead Q1-4 Increase capacity and capability to undertake research in primary care and community settings and ensure patients have the opportunity to participate in research closer to home Continue to provide an annual regional primary care event for researchers, clinicians, and research practitioners with the aim of highlighting opportunities to support chief investigator studies, research funded by the life-science industry and research collaborations between primary and secondary care. RDM Div 5 Q4 LRN/P group to consider additional skills and experience that will be required by staff to work across healthcare providers and develop a training programme outline. WFD Lead Q3 Match skills availability to NIHR CRN Portfolio delivery CRN SWP to issue indemnity guidance and to review status and requirement for the SW Clinical Skills Passport. Within each PO; review new research delivery roles with the aim of: -improving cost effectiveness of the workforce. WFD Lead LRN/Ps Q1 Q4 -ensure sufficient staffing available for portfolio opportunities. Appendix 5 CRN SWP Workforce Development Plan Page 2 of 5

207 Provide clearly communicated career opportunities in clinical research Increase research awareness in the NHS workforce LRN/P group to deliver local Trust research events to highlight the opportunity to engage in research. Promotion of research careers at Universities of Exeter and Plymouth by attending their science and health career fairs. LRN/Ps Q1-4 WFD lead Q4 Produce short video highlighting a day in the life of a research practitioner to promote research delivery careers. Communications Lead Q4 Enable participation and connection through communities of practice Increase capacity and capability of Principal Investigator community Specialty communities of practice will be reviewed Q1-2 including ensuring all RDMs have an established mechanism to enable specialty specific exchange of ideas and support. Support a 10% increase in non-medic PIs across all POs RDMs Q1-4 LRN/Ps Scope the need for adapting DRIVE training for PIs. WFD Lead Q1 Q4 Identify and list experienced PIs who would be happy to act as mentors to new PIs within each specialty. CRSL s Q3 Establish core competency framework for research delivery professionals Embed the RCN competencies (adapted locally for use with non-registered staff) within the development of delivery staff. LRN/Ps Q2 A highly engaged CRN funded workforce Enable efficiency and productivity of the workforce through high performance DRIVE facilitators will meet to review the DRIVE training package in March Following this review the package will be adapted as required. Amend or develop DRIVE training following review with DRIVE facilitators CI Lead Q2 DRIVE champions will receive Continuous Improvement training and role will evolve to become CI champions within each PO. See CI Page 3 of 5 Appendix 5 CRN SWP Workforce Development Plan CI lead Q1-4

208 appendix. See other sections of plan for actions regarding training opportunities and creating new posts to match skills to activity - will help to engage the workforce. Embed learning and skills development in practice environments Engage and connect our communities Provide relevant learning and development in practice setting See communications plan for engaging workforce Continue to deliver the annual regional Research Network Forum maximising attendance from across the region and professions and evaluating feedback to identify future forums/communities of practice. Provide an advanced communications training opportunity for Research Delivery Managers All regional workforce courses will be promoted and administered via CRN learn and training opportunities captured and disseminated centrally. WFD Lead Q4 WFD Lead Q4 WFD admin Q1-4 The Plymouth module will be supported in 2017/18 and opened up to band 4 practitioners with appropriate academic qualification. UoE and UoP Research methods MSc s will be reviewed and an options appraisal completed for funding of modules which would be appropriate for research delivery staff. Scope the requirement for a learning and education package regarding common mental health conditions. Our Training Offer: GCP (online and face to face) Valid Informed Consent Communicating Randomised Controlled Trials (no longer training for this nationally) WFD Lead WFD Lead WFD Lead & Lead Nurse CFT Q2 Q1 Q2 Appendix 5 CRN SWP Workforce Development Plan Page 4 of 5

209 Ensure patients and public contribute to learning and workforce development initiatives Ensure that our workforce has the skills to contribute to the growth agenda Develop our clinical leaders The experience and knowledge of patients and the public is valued and heard within a developmental environment The research workforce has the capacity and capability to deliver research funded by the Life sciences industry Plymouth Module DRIVE modules Facilitators Course Rater training Regional SWP CRN Induction (3x per annum,1 in each county) Fundamentals Clinical Research (not happened in region yet, RCHT piloting) PI training (for psychiatrists- Div. 4 RDM) RNF Leadership programme CLG Lay members speaking on both Community and Research Network Forum and form the judging panel for annual RNF awards. Clinical Director Q1-4 WFD lead Q1-4 Lay members contributing to staff inductions. LRN/Ps Q1-4 Identify patient ambassadors who have experience with workforce development and are prepared to assist with training and development. WFD Lead Q2 Explore industry view of workforce requirements in WFD lead and Q2 the medium term and understand the potential IOM career paths within industry. Identify opportunities for industry delivered training. Appendix 5 CRN SWP Workforce Development Plan Page 5 of 5

210 Appendix 6: Action Plan - Developing a culture of Innovation and Improvement Identifying areas which require innovation and improvement is already embedded within the core CRN SWP workforce and the initiatives and improvements being led by staff within the CRN SWP core team are captured throughout the annual plan. Embedding a culture of I&I within the devolved CRN funded staff requires involvement of the NIHR funded and other workforce funded within the NHS organisations. The DRIVE project provided and will continue to focus on innovation and improvement across research delivery within the Partner Organisations in the previous and next financial year. The community of DRIVE Champions created through the project will support a continued focus on innovation and improvement across the wider workforce. The CRN: SWP CI lead will work with the DRIVE Champions to continue to embed new ways of working and drive quality improvement initiatives and projects. Objective Actions Date Develop quality Create a quality improvement space on the hub to Q1 improvement community of practice support identification and sharing of good practices Develop an innovation and improvement tweet chat Q2 to encourage the use of social media and ask all staff to submit ideas for improvement Arrange two face to face meetings to share good Q1-4 practices, develop new projects and support DRIVE champions to embed quality improvement within their organisations Ensure all RDMs have quality improvement on their Q1-4 agendas in their community of practice meetings Develop access to CI tools on the quality Q1 improvement hub to support DRIVE champions within their POs Utilise the Q webinars at DRIVE and other Q1-4 meetings to support a change in culture Develop clear project and evaluation guidance for Q2 staff undertaking I & I projects Support DRIVE champions to participate in NHS fab Q2 change day. Create collaborations Develop collaborations with the patient safety Q1-4 across the NHS and wider QI community initiative through the SW AHSN and ensure that research is part of the patient safety agenda. Map quality improvement leads to support DRIVE champions undertake lean process mapping and Q1 Communicating and celebrating improvements other methodologies for specific projects. Work with POs to recognise innovation and improvement in annual research awards Develop regional award for innovation and improvement at the yearly Research Network Forum (RNF) event Q1-4 Q4 Appendix 6 Continuous Improvement Page 1 of 1

211 Appendix 7 Digital Plan This document outlines the information and knowledge plan for the Clinical Research Network: South West Peninsula (CRN: SWP). The aim of the plan is to fulfil the requirements of the Performance and Operating Framework (POF) and support the NIHR CRN CC information and knowledge and other strategies with improved use of technology internally with the CRN core team and externally across stakeholders, as well as raising awareness of technology amongst patients. Objective Actions Date Data - making intelligent use of data to enable our work Partner Collaborations - ready to respond to and seize new digital opportunities to deliver research Using Google App Maker, develop an App based on the DRIVE feasibility tools so they become more accessible and easier to use, in partnership with TST. Develop collaboration with AHSN and local CCGs in order to make digital innovation available to support research as well as clinical care. Ensure local CIs are supported by the Study Support Service to use digital technologies to maximise recruitment to trials and ensure efficient data collection and analysis. A pilot project has been undertaken to evaluate the use of pop-up alerts and study specific searches in general practices. An options appraisal will be undertaken for the future funding of this service including review of uptake of tools during pilot phase and implementation of the process to disseminate these tools if evaluation is positive. (Appendix A) Q3 Q1-Q4 Q1-Q4 Q2 Digital maturity - we are innovative and providing digital leadership in our field at all levels Develop a tool using NIHR Hub apps to maintain automatically updated local portfolio maps. Continue to provide local training as required to support the rollout of EDGE LPMS system to GP practices recruiting to the NIHR Portfolio. Ensure all modes of delivery are supported - including online delivery, telephone support and written guidance. Include social media in our Communications strategy and ensure it is appropriately monitored and evaluated. Q2 Q1-Q4 Q1-Q4 Appendix 7 CRN SWP Digital plan Ensure the CPMS/LPMS developments are supported appropriately by ensuring good quality local data, contributing to national discussions and supporting pilot projects as they arise. Page 1 of 3 Q1-Q4

212 Staff facing - a digitally confident and effective workforce using our resources and technology to greatest impact Patients and customers - our customer facing activities are digitally enabled Use NIHR Hub Team Drives to support collaborative working groups within the SW Peninsula, upgrading NIHR hub accounts as required. Ensure direct access to Team Drives from the CRN SWP Dashboard. Redesign the structure of the CRN SWP Website (Dashboard) to make it more user friendly and accessible. Use multiple methods to publicise it including making the website part of the regular signatures for all Core Team and ensure it is kept current and up to date. In line with the National Information Board Personalised Healthcare Framework 2020, ensure patients and the public involved in research locally are encouraged to access the technologies adopted by the CRN to enable them to better engage with the CRN. Include social media, where appropriate, in recruitment planning for new local research projects. Q2 Q1 Q1-Q4 Q1-Q4 2

213 Appendix 3

214 South West Peninsula Clinical Research Network Who we are We support seven acute trusts, three mental health trusts, and an ambulance trust spread over four clinical commissioning group regions. We also work with two research active medical schools, the University of Exeter Medical School, and Plymouth University Peninsula Schools of Medicine and Dentistry. They are working on a portfolio of translational research in neuroscience, cancer, diabetes, cardiovascular medicine, haematology, and hepatology, in collaboration with a registered CTU based in Plymouth and a CTU and CRF in Exeter. Northern Devon Healthcare NHS Trust Plymouth Hospitals NHS Trust Cornwall Partnership NHS Foundation Trust NHS Somerset CCG Somerset Partnership NHS Foundation Trust Taunton and Somerset NHS Foundation Trust Yeovil District Hospital NHS Foundation Trust Royal Cornwall Hospitals NHS Trust NHS NEW Devon CCG Royal Devon and Exeter NHS Foundation Trust Working with the Public Study Walkthroughs Patient groups have been involved in helping research teams get a better understanding of patient experience of trials. Undertaking a study walkthrough can highlight areas patients might find more difficult and help staff plan study visits to ensure trials are run effectively and efficiently and with patient care at their centre. NHS Kernow CCG NHS South Devon and Torbay CCG Devon Partnership NHS Trust Torbay and South Devon NHS Foundation Trust The South West Peninsula is a largely rural region with the population centred around the urban conurbations of Plymouth, Exeter, and Truro and the coastal regions. The total population is 2.2 million, approximately 20% of these are over 65, compared to 15% nationally. Collaborative Initiatives Dementia Collaborations Three dementia focussed collaborations have been set up to support the delivery of dementia studies across the peninsula. This facilitates close working practices between dementia specialists and experienced research nurses, maximising patient access to research. Quintiles Prime Sites As part of an initiative facilitated by the University of Exeter, five of our acute trusts are part of the Quintiles Prime Sites scheme. This encourages open discourse between Quintiles and its partner companies, and the local research community. Research Site Initiative A large proportion of patient contact with the NHS is through primary care, to facilitate access to clinical research for these patients we work extensively with GP practices. Part of this work includes the RSI scheme which provides funding to GP practices to allow the development of research infrastructure. DRIVE Project The DRIVE project (Delivery of Research ImproVEments) aims to optimise research delivery by understanding differences in working practices and identifying ways to reduce variation. A unique feature of the DRIVE project was the harnessing of the right expertise from a range of NHS and academic organisations to make this initiative a true collaboration with a shared commitment to support and deliver high quality clinical research for the benefit of patients and the effective use of NHS resources. Three DRIVE modules Can you do it, Are you ready, and Back on track are currently being delivered to regional research staff.

215 South West Peninsula Clinical Research Network Business Intelligence and Information Systems The business intelligence team supports the LCRN and wider research community through the provision of reports, tools, and training. Local Portfolio Management EDGE is the local portfolio management system; used across the acute and mental health trusts and an ongoing project to support the roll out in Primary Care. Central Portfolio Reporting To streamline reporting processes a LCRN specific ODP reporting app has been developed to provide breakdowns of study recruitment relevant to local reporting needs Performance Management Tools To support performance management and planning in our partner organisations we have developed time and motion and capacity tools these are being piloted in a number of sites across the region Infographics To support strategic planning and commercial activity we have produced a number of infographics capturing epidemiological and prescribing data to support robust feasibility, population and clinical needs What we do 2015/2016 Research Activity In the 2015/2016 financial year we recruited a total of participants to clinical trials, of these 1693 were to commercial trials. This included recruitment to all specialty portfolios, and across all our partner organisations and GP practices from across the region. Our largest recruiting portfolios for 2015/2016 were Primary Care; Diabetes, for which we were 3 rd highest nationally; and Injuries and Emergencies, for which we were 2 nd highest nationally. The largest commercial portfolio was also Primary Care, for which we were 5 th nationally Workforce Development We aim to establish flexible workforce models that support research delivery across organisational and divisional boundaries. We engage and connect our clinical communities through the delivery of annual events including the regional Research Network Forum and the annual regional primary care event for researchers, clinicians, and research practitioners. These highlight opportunities to support chief investigator studies, research funded by the life science industry, and research collaborations between primary and secondary care. The regional induction handbook has been updated to signpost training opportunities and adapted for the workforce undertaking research in primary care and community settings. Current workforce development work streams include mapping exercises to identify the capacity and capability of the non-nihr funded research workforce in primary care, the potential to increase the number of non-medic principle investigators and to explore workforce training needs and develop bespoke training packages where required.

216 Proposal from the Regional Funding Model Review Group for Funding Principles and Allocations in 2017/18 for CRN SWP Clinical Research Network South West Peninsula 1. Background 1.1 Funding is allocated to the 15 Local Clinical Research Networks (LCRNs) from the NIHR Clinical Research Network national Co-ordinating Centre (CRN CC) to support activities described in the LCRN contract which includes the Performance and Operating Framework (POF). 1.2 Whilst activity forms an element of the model, LCRN budgets are not derived by means of a pass through model. LCRNs are awarded a proportion of a fixed allocation; it is therefore possible for activity to increase with no corresponding increase in allocation if activity in other LCRNs is proportionally higher. Funding is allocated to support all activities outlined in the POF which include all aspects of research delivery, Patient and Public Involvement and Engagement, Workforce development and continuous improvement in research delivery. 1.3 The national modelling principles used to determine LCRNs budgets for 2017/8 were: LCRN Leadership and Management for posts defined in the NIHR contract ring fenced allocation all LCRNs receive the same allocation of (4.3% national budget) Top slice - National Chairs of specialty groups , each (0.3% national budget), a Radiotherapy Trials Quality Assurance service (RTTQA) (0.4% national budget), Paediatric Pharmacy and Formulations Funding (0.0% national budget), Chemotherapy and Pharmacy Advisory Service (CPAS) (0.0% national budget) A per capita element, 15.1% of the national allocation ring fenced allocation all networks receive a proportion of the allocation based on population size, SWP allocation is 1,780,476 Project-based funding, that is the number of studies a Trust has opened requiring management (and is not the number of recruits), this includes study-wide and local activities as well as NIHR CRN Study Support Service activities, 6% of national allocation. SWP allocation is Performance based element to recognise and incentivise high performance in study delivery allocated based on commercial global first patients and time to target performance 5m, 1.8% national budget. SWP allocation is Recruitment related funding (known as activity based funding (ABF)), 72.2% of the funding using recruitment over the past two years as a surrogate for all study activity, including for example consent and follow-up. The activity based funding year runs from 1 st October to 30 th September. A simple complexity ratio was used with studies recruiting > attracting 1 point, observational studies 3.5 and interventional studies 11. A Market Forces Factor was applied; this reduced the SWP pre cap/collar allocation by The final LCRN allocation was then subject to a Cap and Collar i.e. an allocation plus or minus 5% of the previous year s allocation. For the past two financial years DH made a further 6m available. Flow through funding was paid to PIs who had achieved global firsts or achieved RTT; this has been withdrawn for 2017/ Outside of the core elements, the majority of this budget (72.2%) is a model predicated on what has happened previously using recruitment activity only as the surrogate for predicting future activity and funding requirement. No national contingency is held and LCRNs are expected to achieve Performance and Operating Framework objectives within their fixed allocation. This includes funding the Host function; Core Leadership team; Study Support Service; clinical sessions for all professions and other service support costs; Patient and Public Involvement and Engagement; Training and Education and Continuous Improvement in research delivery. Page 1 of 7 CRN SWP Funding Principles and Allocations 2017/18 V1.0

217 1.5 The allocation made to the Clinical Research Network: South West Peninsula (CRN: SWP) for 2015/16 was 11.1m, a 5% reduction on the 2014/15 allocation. Funding for 2016/17 was 11.1m (including flowthrough & national specialty lead funding). The allocation for 2017/18 is ; this represents a 2.8% decrease; if the loss of flow through is also taken in to account the reduction to the region is 5.9%. 1.6 Following national guidance, the local allocation has not adopted a pass through model and account has been taken of local knowledge including local and national priorities, to resource flexibly to support continued activity as well as to support an increase in activity. Strategically allocations have followed a 'necessary and sufficient' approach with the requirement to maintain capacity, capability and stability, whilst managing the decreases in funds. 2. Proposed Finance Allocation Principles 2.1 During 2016/17 a regional funding model review group was convened to review the guiding principles for local resource allocation. Key stakeholder groups were identified to support this review including R&D Director s, R&D Manager s, Lead Research Nurse/Practitioner s, General Practice, Chief Investigators and Principal Investigators as well as network Clinical Research Leads and Specialty Leads and senior management staff. Partner organisation membership for Trusts reflected mental health, small and large acute Trust experience (membership appendix A). 2.2 The group met monthly from April 2016 and considered all current guiding principles of the model by means of options appraisals. The principles were reviewed by the CRN SWP Executive group and a further two principles were added outlined in 2.3 B I a +5% increase and 2.3 BII at > 10% decrease for PHNT. 2.3 The following were agreed as the guiding principles for funding: A. Funding follows activity and is used for permitted activities as outlined in the Performance and Operating Framework B. Cap and Collar. I. Funding will be capped at no more than a 5% increase in funding for any organisation. II. Funding will be capped at no more than a 12.5% decrease the percentage decrease will be stratified to take account of the ability of the organisation to generate commercial income with large Trusts capped at 10%, with the exception of PHNT which is the most commercially active of the three large acute Trusts (appendix B); based on activity over the past two years a significant decrease in funding (-26%) would have been applied without a cap compared to a significant increase (+34%) if a cap were not applied at RCHT. PHNT have historically been in receipt of the highest amount of historical funding, thus previous capped reductions in line with a reduction in ABF activity, have not reduced the funding to the Trust at a rate which would reflect their current activity in comparison to other organisations; medium sized Trusts capped at 7.5% and small Trusts capped at 5% C. Consideration is given to the NIHR High Level Objectives (HLO s) as set out in the Performance and Operating Framework. D. Consideration is given to the NIHR Specialty Objectives as set out in the Performance and Operating Framework. E. Partner Organisations in receipt of funds > 50k provide a full annual plan outlining proposed use of funds and the plan the organisation has to achieve contractual requirements. Organisations in receipt of < 50k funding will provide a business case for continued funding. F. Funding will be top sliced for the following, the level will be reviewed annually by means of a business case for each element: I. Host Function II. LCRN Leadership and Management III. Primary Care Service Support Costs, Research Site Initiative and Clinical Support Team IV. SWASFT V. Mental Health Trusts VI. Regional Genetics Service VII. Other cross cutting contractual obligations G. A contingency will be held; account will be taken of Trust RCF and commercial generation capacity when considering any contingency applications. All applicants must provide explicit assurance that funds will not be used for CIP. H. Incentivisation and recognition of excellence in performance: A team award for opening a study in a new specialty or with a research naïve department/provider and achieving RTT will attract an award Page 2 of 7 CRN SWP Funding Principles and Allocations 2017/18 V1.0

218 of up to 500 for the team to support Training and Education. Awarded at end Q2 for previous four quarters. I. Collaborations to deliver division four studies have successfully developed over the past two years with partner organisations working together to deliver studies, recruitment activity is attributed to one Trust within the collaboration. To reflect and encourage this new model of working the allocation of resource within division four will be proposed by the division four CRL and RDM following consultation with division four CRSLs and partner organisations. J. Funding is necessary and sufficient and that knowledge of the actual requirements to deliver the portfolio are taken in to account 3.0 Allocations based on model 2017/ Host allocation: The Host is permitted to allocate 400k or 2% of the LCRN allocation to support the hosting function; RDE host allocation is (1.4% total budget). 3.3 Leadership and Management: The network leadership and management (L&M) team is defined in the LCRN contract and includes a CD 5PA, 1.0 wte COO, 6.0 wte RDM s, 1.0 wte cross cutting Manager and 1.0 wte Industry Operations Manager. There is a ring fenced allocation for these posts which sits outside of the allocation made to the network for activity of 808k. The CRN SWP L&M team allocation is Core activities: Within the LCRN contract are requirements to provide support to the L&M team, to provide a study support service and to undertake supportive research delivery activities across the region, these include Continuous Improvement; Workforce Development; Business Intelligence; Business Development, Support for Life Sciences; Public and Patient Involvement and Engagement and Communications. The proposed allocation is (12.1 wte band 3-7 staff). 3.5 The network is expected to have clinical leadership across the divisions and for each specialty area; CRSLs also undertake national responsibilities to support research delivery across the NHS in England. Clinical Research Leads for each division will be supported with 1PA and other leads will be supported with funding equivalent to between 0.25 and 1PA. Funding of will be reserved for CRLs/CRSLs. The network is also expected to support a Midwifery Champion 2272 is reserved. 3.5 Local Portfolio Management System (LPMS): There is a contractual obligation to have a LPMS, the EDGE system is used in the SWP region and is 78k per annum. 3.6 Primary Care: Primary Care contributed 17% of non-commercial recruitment in 2014/15; 29% in 2015/16 and 29% YTD (28/11/16). In relation to ABF recruitment activity contributed 17% of ABF points. Funds for primary care include a reserved allocation for service support costs (SSCs), sessional practices, Research Site Initiative (RSI) and the Clinical Support Team. SSC s are paid directly to general practices based on activity. Payment of SSCs using this process pre-dates the current contract and enables the budget to be managed proactively with funds not required released in a timely fashion back to the general contingency. A SSC allocation of 200k is reserved based on historical requirements and analysis of the current and pipeline portfolio. Funds not required for SSC will be made available to general contingency. Twelve sessional practices are supported which have advanced capability to support the study support service and more complex studies. Each practice receives an allocation of which represents a cost saving of with now reserved. The Research Site Initiative (RSI) enables practices to be research ready and undertake other research activities such as patient identification for other sites, this is paid at two levels dependant on agreed activity ( 1425 & 3800) this is 5% less than 2016/17 representing a cost saving of 6050 with a reserved allocation of The Clinical Support Team have both registered and non-registered staff who provide a flexible delivery resource able to support all aspects of study delivery from site identification, feasibility, recruitment and close out of studies across the region with all General Practice and community providers is reserved for these staff. The network also supports a Primary Care Pharmacy Champion to support research community Pharmacies to both support research delivery as well as Community Pharmacists acting as both CIs and PIs for clinical studies, 12k is reserved. Funding will continue to be provided for a research Occupational Therapist and administrative support at Livewell. Funding of between 0.5-1PA will be held in the contingency pending appointment of a Clinician to lead for research. Page 3 of 7 CRN SWP Funding Principles and Allocations 2017/18 V1.0

219 3.7 SWASFT: A research facilitator and Research Paramedic time will be supported with Regional Genetics Service: Utilising the musketeer s agreement, the Regional Genetics Service based at RDE recruits patients from across the region to genetics studies, 35k will be provided to support ongoing recruitment in this service. 3.9 Mental Health Trusts: An agreed funding principle is the ring fencing of funds to the Mental Health Trusts given their limited ability to generate further income (e.g. in 2016/17 only six studies have been available nationally to the 54 MH provider Trusts). In reviewing activity for the past two years it can be seen that activity has risen in CFT and SomPar and that the contribution of these Trusts to overall recruitment is now slightly higher than DPT (although if Devon Dementia Collaboration recruitment was shared between RDE & DPT the three MH Trusts would be very similar). Funding to DPT has been higher than CFT and SomPar by approx. 100k per annum from the start of the revised contract. It is therefore proposed that DPT receive the same allocation as 2016/17 282k and that CFT and SomPar be uplifted by 2% to 174k and 113k respectively. It is expected that proposal I (section 2) in relation to division 4 delivery would also ensure further support to all MH provider Trusts and that the research delivery CFT and SomPar support outside of division four as community health providers will be supported by the regional CST A number of collaborations have now been established across the region to support delivery of Division four studies and it is anticipated that to continue to grow particularly DeNDRoN activity but also Mental Health, Neurology and Stroke that a revised approach to allocating resource would be most supportive of ensuring the appropriate resource is made available within the patient pathway rather than being siloed in organisations. The CRL and RDM for Cluster Four will work with clinicians of all organisations in receipt of current cluster four funds to agree use of resource. It is expected staff will continue to build on established collaborations working across the patient pathway and therefore healthcare providers. Funds of 1.151m are currently reported as being used to support Division 4 and Stroke across all acute and mental health providers. It is expected in 2017/18 that the majority of these funds as they support staff in substantive posts will still be allocated to the organisations currently in receipt of these funds. As a decrease in funds has occured, there is potential for the 1.151m allocation to be reduced agreement for an acute Trust to make the proposed saving in cluster four would be made in conjunction with the Cluster four CRL and CRSLs given HLO7 and the already low activity in mental health research. Currently 22k is provided centrally for a rater to cover studies across Somerset, this amount has been reserved again for 2017/ To support all non-pay costs for CRN SWP staff, CRLs / CRSLs and others as required and meetings, educations events and consumables 100k will be reserved To support training and education the network reserves 10k centrally to support the Plymouth Module and other educational courses (e.g. GCP; Communicating about randomised controlled trials ). A band wte practice facilitator is also supported to run the Plymouth Module and to provide other workforce development support 10k is reserved A contingency will be reserved which will be the balancing figure once the model has been run according to the principles above. Vacancy factor from central posts, any underspend from the primary care service support cost and any other centrally held budgets will be released to contingency k is reserved for non-medic and medic fellows to support green shoots and capacity building; investment in improvement in delivery is provided with 85k reserved to continue the DRIVE facilitator posts for one more year. Page 4 of 7 CRN SWP Funding Principles and Allocations 2017/18 V1.0

220 3.13 The information above is summarised in table 1 below: Table 1: Proposed allocations Host Regional Genetics Service Leadership & Management CFT 173,844 Core functions DPT CRL / CRSL SomPar LPMS Midwifery Champion 2272 Primary Care SSC / RSI / Sessions 452,950 Training and Education Clinical Support Team Non-pay 100,000 Primary Care Pharmacy Champion Contingency Rater Somerset Medic / Non-medic Fellows SWASFT DRIVE facilitators Livewell The remaining funds will be allocated to the acute Trusts based on activity over the past two ABF years: Table 2: Proposed allocations CRN SWP acute Trusts NDHT PHNT RCHT RDE SDHT TSFT YDT without cap overall % movement -17% -26% 34% 11% -30% 6% -26% - 5% cap -5% -12.5% 5% 0% -7.5% 0% -5% Funding NIHR Clinical Research Network funding is not the only funding source designed to support NIHR portfolio delivery or to support all research at Partner Organisations. NIHR Commercial activity must be undertaken on a full economic cost recovery basis. POs must ensure they have identified research costs and have a process to identify and fund these costs outside of the NIHR CRN allocation unless these costs are covered according to AcoRD or ARCO guidance. Trust RCF is expected to be used to support activities as identified in the AcoRD guidance, table 3 below shows Trust RCF allocations for Table 3 Trust RCF Allocations 2017 CFT 0 TSDFT 20,000 DPT 355,006 YDH 20,000 SomPar 0 SWASFT 207,709 NDDH 20,000 Kernow CCG 20,000 PHNT 51,840 NEW Devon CCG 20,000 RCHT 166,804 SDT CCG 20,000 RDE 781,675 Somerset CCG 20,000 TSFT 34,311 Page 5 of 7 CRN SWP Funding Principles and Allocations 2017/18 V1.0

221 Appendix A Membership of the Regional Funding Model Review Group Jo Allison Dr Camille Carroll Tobit Emmens Chris Gardner Dr Lisa Gibbons Prof Ruth Hawker Dr Pauline McGlone Dr Gary Minto Helen Quinn (Chair) Paula Underhill Hengxing Wei Dr Duncan Wheatley Joy Wylie YDH Lead Research Nurse and R&D Manager PHNT Honorary Consultant Neurologist; Post-Doctoral Research Fellow University of Plymouth; CRN: SWP CRL Cluster Two & CRSL Parkinsons DPT Managing Partner Research and Development RDE R&D Directorate Manager GP & CRN: SWP CRSL Primary Care CRN: SWP PPIE Executive Group Member CRN: SWP Deputy COO PHNT Consultant Anaesthetist & CRN: SWP CRSL Anaesthetics CRN: SWP COO CRN: SWP Industry Operations Manager RDE Host Management Accountant RCHT R&D Director; CRN: SWP CRL Cluster; CRSL Cancer and Sub-specialty Lead for Breast cancer CRN: SWP Senior RDM Cluster Five Page 6 of 7 CRN SWP Funding Principles and Allocations 2017/18 V1.0

222 Appendix B Commercial and non-commercial data 2016/17 to Jan 2017 % No. Total Studies No. Commercial studies commercial studies Total Recruitment Commercial Recruitment NDDH PHNT RCHT RDE TSFT TSDFT YDH Page 7 of 7 CRN SWP Funding Principles and Allocations 2017/18 V1.0

223 LCRN Annual Delivery Plan 2017/18 CRN SWP Room N8 ITTC Building Plymouth Science Park PL6 8BX Tel: Web:

224 Appendix C NIHR CRN CC feedback letter annual report NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans

225 Mr Adrian Harris Executive Medical Director Royal Devon and Exeter NHS Foundation Trust Royal Devon and Exeter Hospital Barrack Road Exeter EX2 5DW 10 July 2017 Dear Mr Harris LCRN Annual Report 2016/17 Thank you for submitting CRN South West Peninsula s Annual Report (including your year-end finance return) for 2016/17. The timescales for development and submission of your Report following release of the guidance were challenging and we would like to thank you for all the hard work that went into producing the Report, and for providing it within the requested deadline. I am pleased to confirm that the review panel recommended your Annual Report was approved. 1. Specific feedback on CRN South West Peninsula Annual Delivery Report The review panel highlighted a number of points which we hope you will find helpful: a) The infographic Our Wall of Fabulous Stuff at the beginning of the report was excellent, and effectively captured key successes from 2016/17. b) The report provided clear evidence of the networks effective linkage with other LCRNs and we commend you on your one-network approach. c) We congratulate you on your total recruitment (HLO 1), exceeding your local forecast and target with 24,838 patients recruited against your local forecast target of 22,505, on your strong HLO 7 performance, recruiting 1,366 against your local target of 750, and on achieving three Global first recruits in 2016/17. d) It was noted that for HLO 2A performance fell short of the national 80% target but performance improved considerably from 54% in 2015/16 to 69% in 2016/17, and we are assured that Delivering research to make patients, and the NHS, better

226 appropriate plans are in place to enable you to meet the national target in 2017/18. We look forward to discussing the approach for improving performance in 2017/18. e) Specialties: the report provided an excellent summary demonstrating good performance overall against the Specialty Objectives. f) The network s effective use of workforce skills and planning was evident from the report g) We congratulate the network on excellent work in 2016/17 in delivering a comprehensive, relevant and increasingly embedded approach to Communications and PPIE. The roll-out of the patient study walk through scheme and the involvement of patients in presenting awards to researchers and research staff at the network s annual Research Network Forum event are excellent initiatives. 2. Specific feedback on CRN South West Peninsula Year-end Finance Return There were no specific comments from the review panel. 3. General comments that the review panel felt were important to feed back to all LCRNs Section 1 of the majority of LCRN Annual Reports provided confirmation that the Host Organisation delivered the LCRN in full compliance with the DH/LCRN Host Organisation Agreement in 2016/17 and that all Partner organisations operated in full compliance with the 2016/17 POF. Elsewhere in many of the reports there were comments that suggested possible instances of non- or partial-compliance in 2016/17. As discussed at the recent CRNCC/LCRN Liaison meeting the CRNCC will be in touch about contract compliance monitoring. Annual Review Meeting We look forward to the network s forthcoming Annual Review Meeting, and to reflecting on and discussing the achievements and challenges in your area in 2016/17 as well as progress in the implementation of your 2017/18 Annual Plan. We very much look forward to working with you in the coming year to support you in building on your strong and successful performance in 2016/17. Yours sincerely Amber O Malley Head of Performance Management NIHR Clinical Research Network cc Professor Anthony Woolf, Clinical Director, CRN South West Peninsula Helen Quinn, Chief Operating Officer, CRN South West Peninsula Dr Jonathan P Sheffield, CRN Chief Executive Officer John Sitzia, CRN Chief Operating Officer

227 Professor Nick Lemoine, CRN Medical Director Dr Susan Hamer, CRN Director of Nursing, Learning & Organisational Development Dr Clare Morgan, CRN Research Delivery Director Dr Matt Cooper, CRN Business Development & Marketing Director Nick Hirst, CRN Chief Information Officer Sarah Thorp, CRN Head of Finance Seema Verma, CRN Head of Finance

228 Appendix D NIHR CRN CC feedback letter annual plan NIHR Clinical Research Network: South West Peninsula Annual Report and annual plan and finance plans

229 Adrian Harris Executive Medical Director Royal Devon and Exeter NHS Foundation Trust Royal Devon and Exeter Hospital Barrack Road Exeter EX2 5DW 22 June 2017 Dear Mr Harris LCRN Annual Plan 2017/18 Thank you for submitting CRN South West Peninsula s Annual Plan (including Annual Financial Plan) for 2017/18. The timescales for development and submission of your plan following release of the final guidance were challenging and we would like to thank you for providing this information within the requested deadline. I am pleased to confirm that the panel recommended that your Annual Plan was approved subject to the conditions and clarifications noted below. 1. Specific feedback on CRN South West Peninsula Annual Delivery Plan a) The overall plan was clear, well presented and provided assurance the network has appropriate plans in place to deliver against the national targets, strategies and goals. b) HLOs: The review group noted that your HLO 2A performance improved to 69% and that you estimate you will achieve 70% for HLO 2A in 2017/18. However, as HLO 2, and HLO 2A in particular remains a national CRN priority for 2017/18, the expectation is that all networks plan to meet the national 80% target for HLO 2. We note that you estimate you will not achieve the national targets for HLO 5 in 2017/18. We encourage you to stretch your performance to achieve these targets. In relation to HLO 5 and work to develop an alert system for FPFV following confirmation of capacity and capability. We encourage you to share your experience Delivering research to make patients, and the NHS, better