Annual Delivery Report: 2015/16 CRN: Greater Manchester. Version: 1.0 Date submitted:

Transcription

1 Annual Delivery Report: 2015/16 CRN: Greater Manchester Version: 1.0 Date submitted:

2 Contents Section 1: Compliance with the Department of Health / LCRN Host Organisation Agreement Section 2: Contribution to National NIHR CRN Performance Indicators Section 3: Report on performance against the LCRN Development and Improvement Objectives for 2015/16 _ Section 4: Report on performance against the CRN Operating Framework Compliance Indicators _ Section 5: Report on performance against Patient, Public Involvement and Engagement, Continuous Improvement and Workforce 2015/16 plans _ Section 6: Host Organisation report on performance against the LCRN Host Performance Indicators _ Section 7: Other local innovation and initiatives _ Appendix 1: Report on network s contribution to achievement of the 2015/16 Clinical Research Specialty Objectives Appendix 2: Report against the network s Patient, Public Involvement and Engagement Plan 2015/16 Appendix 3: Report against the network s Continuous Improvement Plan 2015/16 Appendix 4: Report against the network s Workforce Plan 2015/16 2

3 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 in 2015/16 including Appendix A Performance and Operating Framework (POF) Yes No 1.2. If you have answered no above, please specify the clause(s) and provide an explanation of why it has not been possible to achieve compliance in 2015/16. [LCRN to provide details as appropriate] 1.3. Please complete the table below to confirm that the enclosed Delivery Report has been approved by the LCRN Host Organisation Board or is scheduled to be approved by the LCRN Host Organisation Board. Signature: Name and job title of signatory: Date of signature: Date when approval was obtained or is expected: Approval expected July

4 Section 2: Contribution to National NIHR CRN Performance Indicators This section should summarise the network s contribution to the CRN s Performance Indicators. 2.1 NIHR CRN High Level Objectives 2015/16 Please complete the table below by (a) entering details of 2015/16 local goals for HLOs 1 and 7; (b) entering details of specific plans against all the objectives as presented in your 2015/16 annual business plan. Please add details of any additional actions undertaken, as needed. (c) For each objective, please complete the right column, commenting on your network s performance against your plans for 2015/16 and local targets, where applicable. Please include: key achievements, successes and challenges, and where possible, reasons or an explanation for these. Objective Measure CRN Target LCRN Goal Specific Key Local Activities for 2015/16 Performance against plan 1 Increase the number of participants recruited into NIHR CRN Portfolio studies Number of participants recruited in a reporting year into NIHR CRN Portfolio studies 650,00 0 Local CRN GOAL 33,745 CRN CC 35,493 HLO 1 Goal Local Goal A drive on proactive engagement with Industry and Academia to encourage further activity Strong engagement with CIs, PIs, Clinical Research Specialty Leads and other members of local research teams Awareness raising events will be held by Divisional and Cross Divisional staff about HLOs and best practice in meeting the appropriate metrics. These will engage with local R&D Offices and delivery teams 36,590 (103%) 36,590 (108%) In 15/16 each of the Research Delivery Managers (RDM) has linked closely with the research teams within the academic communities through their respective specialities, building relationships and promoting how studies can be adopted and how the Network can support and help deliver these key projects. This work has been underpinned by our Speciality Leads who all play a pivotal role as ambassadors for CRN:GM The Industry team have established relationships with Life Science Companies and Clinical Research Organisations which have been refined in this FY.The 4

5 team are now providing an increasingly solution focussed service and agile response. All studies within CRN: GM are performance managed in order to ensure successful delivery to time and target. 2 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% 80% Focus on robust feasibility with expansion of Network Industry team to include a new Industry Delivery Manager and additional Facilitators. Network Industry team member to attend site selection visits and site initiation visits wherever possible. GM Closed Network Sites 84.6% to time and target. The Industry team have welcomed the new Industry Delivery Lead role and it is a fully established post. The team also has 2 new Research Facilitators who have also contributed to the local push on feasibility and ongoing performance management. The focus on feasibility has improved the overall delivery performance in GM to 84.6% to time and target for closed commercial studies in 2015/16. The Research Facilitators in the Industry team attend all site selection and site initiation visits as planned in the 2015/16 Annual Plan. The team work closely with local research teams and Investigators to encourage swift set up times and realistic targets. 5

6 Industry teams to hold regular performance management meetings to review studies at site level Industry Performance review meetings are held bi weekly. They are led by the Industry Delivery Lead and attended by all core members of the Industry Team. B: Proportion of non commercial studies achieving or surpassing their recruitment target during their planned recruitment period 80% 80% RM&G team to become Study Support Service team with focus on early engagement in non commercial studies, including pre application support, cost attribution and Increasing the use local feasibility tools, and other data sources, to support evidence based feasibility Review and work with stakeholders, (partner organisations, research teams, CTU, local sponsors) across the Network to set up events to share best practice on recruitment to studies 75% During 2015/16 the RM & G team remained in place supporting the outgoing CSP system. The new Study Support Service of CRN:GM will become operational in 2016/17. However throughout this period of transition the performance metrics have remained high across the academic and commercial portfolios. Development of a core group Of Senior Research Nurses and Clinical Studies Officers within the CRN who can support studies and study teams across Greater Manchester when required has enhanced our overall performance. Chief Operating Officer and Clinical Director to set more regular meetings with Clinical Research Specialty Leads to discuss performance and funding Three Specialty Group Meetings have been held within 2015/16 The meeting is led by the CD and COO and all Divisional Leads and Specialty Leads are invited. Attendance has been very high throughout the year and provides 6

7 an opportunity for GM and Individual Specialty Performance Reviews, funding discussions and external speakers to attend and discuss potential new CRN collaborations 3 Increase the number of commercial contract studies delivered through the NIHR CRN A: Number of new commercial contract studies entering the NIHR CRN Portfolio 600 n/a Establish more partnership arrangements, through the Business Development Manager, with industry sponsors and CROs to provide Greater Manchester with first look opportunities for potential commercial trials GM Lead 27 studies (includes 22 live & 5 draft) In 2015/16 the Business Development Manager has continued to collaborate with industry sponsors.sponsors have met with individual Trusts where appropriate and have added stakeholder collaborations with the 3 GM CRFs (The Christie UHSM MEU and NIHR Wellcome Trust) for early phase contact. Partnership working with Manchester Academic Health Science Centre (MAHSC) in their business development activities CRN GM continue to have strong connections to MAHSC for operational and strategic research collaborations and projects. The Business Development activities in 2015/16 looked at closer GM links with Roche. All feasibilities will be part of Industry Operation Manager s review project (LEAN SixSigma project through NIHR CRN The Industry Operations Manager took part in the LEAN SixSigma project as part of the NIHR Continuous Improvement Programme 7

8 Continuous Improvement) to ensure greater uptake of commercial studies. 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 75% n/a Through a new joint initiative, CRN: GM will build a stronger relationship with the Greater Manchester AHSN with focus on increasing commercial activity in the area, particularly in medical technology Planning & execution of a new marketing communications campaigns aimed at publicising the positive commercial clinical research environment within Greater Manchester Identification and engagement initiative with partner organisations who continue to participate in a high proportion of non portfolio commercial research. Information resources to be provided for sponsors to stress the benefits of NIHR CRN Portfolio inclusion. Innovation Champion initiative developed. Collaborative workings between Industry Operation Manager and AHSN delivery partners (Trustech). Speciality Leads used as resource to secure clinical review of SME innovation technology submitted to AHSN via the Innovation Nexus.Technologies reviewed for research applicability and development plans applied. In 2015/16 the four northern CRNs came together with the Northern Health Science Alliance in order to produce materials showcasing our industry capability across the Northern Powerhouse. This project will continue in 16/17. The Information and Communication teams have supported the Industry team in sharing good news stories about local network support for sponsors. The performance data provided by the Information team demonstrates the value to companies and sites about how effective early 8

9 engagement with the Industry team can be. Core Industry slides have been produced to highlight the benefits of NIHR portfolio inclusion. 4 Reduce the time taken for eligible studies to achieve NHS Permission through CSP Proportion of eligible studies obtaining all NHS Permissions within 40 calendar days (from receipt of a valid complete application by NIHR CRN) 80% 80% A new quarterly e communication will be sent to all partner organisation R&D offices showing the performance of the Trust in terms of set up time (range and median) from study Valid R&D form submission to local NHS permission. The CRN core RM&G team will focus on Lead LCRN activity around NIHR CRN Study Support Service, developing new SOPs to facilitate timely set up processes including more structured pre award and pre application support. 85% 75 out of 88 eligible studies. This was not implemented because the benefit of this activity was already realised through Performance in Initiating and Delivering Research (PID) procedures. The CRN core RM&G team focussed on delivery of NIHR CRN Study Support Services to national SOPs as they were released and updated throughout the year. The CRN RM&G team will assist MAHSC Trusts in their collaborative efforts to provide mutual recognition around set up approval processes and to The CRN RM&G Team worked to assist MAHSC with their collaborative efforts, leading to the implementation of standardised fees and services in some areas in

10 spread this initiative throughout the whole CRN area. 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 calendar days of NHS Permission being issued or First Network Site Initiation Visit, at confirmed Network sites 80% 80% The expanded CRN:GM Industry team will allow more regular performance management meetings to review all commercial studies running at each site level. 60% The bi weekly performance meetings objectives are to identify the time to target status of studies. This enables the team to have an narrative around the volume of studies which are achieving their recruitment targets,and those who may require extra support. The Industry Delivery Lead identifies and delivers on studies which are identified as at risk of not delivering time to target. A bespoke intervention is agreed to facilitate site support. The expanded CRN:GM Industry team will allow greater coverage of all GM commercial SIVs. In 2015/16 the Industry team had 2 new Research Facilitators. This gave GM the capability for network support at commercial local site selection and site initiation visits. The IOM will hold regular commercial performance meetings with Network Research Delivery Managers to performance manage through the Specialties. The IOM attends the monthly CRN GM Executive meeting where all the specialties are discussed with the Divisional/Speciality Leads. The IOM also attends bi weekly Operational Management Meetings 10

11 with the Research Delivery Managers. B: Proportion of non commercial studies achieving first participant recruited within 30 calendar days of NHS Permission being issued 80% 80% The Network RM&G team will begin to focus on particular aspects of the new national NIHR CRN Study Support Service, including non commercial study deliverability. Network RM&G team to attend local Research Design Service meetings to engage with non commercial studies early. 54% Although this remains below target, when compared with 14/15 where 37% was achieved, CRN:GM have made significant improvements across the portfolio working in partnership with the research teams and trusts. The Network RM&G Team worked closely with RDMs to deliver effective support during study design and set up, including NHS capacity and capability to deliver the research. Network RM&G attended local RDS events to provide study support services to researchers and continue to liaise with RDS to provide further collaboration. 6 Increase NHS participatio n in NIHR CRN Portfolio Studies A: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio studies 99% 99% Senior Level engagement through the partnership group. Continued strong engagement with study teams around the 100% In 2015/ studies in Greater Manchester were open and recruiting across 29 of the 30 specialities the 5th largest study portfolio. This demonstrates the breadth and depth of the activity 11

12 importance of recruitment upload via Information Team. across Greater Manchester and the opportunities it presents for our patients in our partner Trusts. B: Proportion of NHS Trusts recruiting each year into NIHR CRN Portfolio commercial contract studies 70% 70% Expansion of core Industry team will allow more involvement with sites with previous low commercial activities.(e.g. Mental Health Trusts) to try to place studies. Business development activities (through the dedicated Business Development Manager) will target commercial naïve Trusts. 63% The Industry Team expansion in 15/16 ensured Industry support was more available. This allowed the smaller Trusts to benefit from the team s experience and expertise and it is testament to the team s efforts that a higher number of commercial studies were offered to these organisations and will be open to recruitment in 16/17. For example, increased commercial portfolios are now in place at Pennine Acute Trust, East Lancashire NHS Trust, and Wigan Wrightington and Leigh NHS Trusts in Speciality areas agreed with each R&D Directorate driven by the Industry Business Development Manager. The Business Development Manager is continually engaging with Trusts to encourage new areas of commercial research and working with potential new Principal Investigators. Sites are supported by the Industry team from the first tentative steps 12

13 through to successful delivery of studies. C: Proportion of General Medical Practices recruiting each year into NIHR CRN Portfolio studies 25% 25% Primary Care Specialty Lead to continue to develop promotion activity of NIHR CRN Portfolio studies to GP Practices 39% Primary Care Lead was very actively involved in local meetings and initiatives across Greater Manchester in order to promote the NIHR CRN. CRN GM to continue to promote Research Site initiative scheme to Practices The Research Initiative scheme was introduced and encouraged with local practices through local discussions. CRN GM to continue to develop research team to support delivery at practices Primary care CRN nursing team supported commercial and academic studies within GP practices. Successfully delivered the HEAT study in several practices. Strengthening relationships between the network and primary care. Greater Manchester is working with GP Practices by providing either the expertise or resource to encourage new sites to deliver. 7 Increase the number of Number of participants recruited into Dementias and Neurodegeneration 13, (139%) 13

14 participants recruited into Dementias and Neurodege neration (DeNDRoN ) studies on the NIHR CRN Portfolio (DeNDRoN) studies on the NIHR CRN Portfolio RDM will continually review current activity ensuring recruitment to time and target and maintain an overview of the portfolio pipeline Performance reviews with the Specialty Leads take place on a monthly basis The PI Training Programme initiated in 2014/15 will once again take place in 15/16 to ensure ongoing development of new Principal Investigators in order to support a growing portfolio of dementia research A capacity review is taking place across the partner organisations supporting dementia research to ensure that the correct research infrastructure is available to support abroad and complex portfolio The RDM, Specialty Leads and GM Industry team are working together to place as many commercial dementia studies within Greater Manchester The Join Dementia Research system has been successfully implemented and will continue 2015/16 represented another strong year in DeNDRoN study performance and pleasingly there has been a 25% increase in studies. Close working between the RDM, Speciality Lead and partner Trusts supported by a highly proficient research team has enabled successful delivery of both complex interventional and observational studies. The PI training Programme was once again delivered in 2015, again enhancing our PI pool and learning materials are now going to be shared nationally through the Workforce leads. The Join Dementia Research Team has successfully matched nearly 50% of volunteers to a study during 2015/16 and have been recognised nationally for their efforts. In GM there is a substantial cohort of dementia raters ably led by the PLFs. Some of our raters are Industry accredited and in 2015/16 they have continued to maintain their skills through involvement in non commercial and commercial 14

15 to support recruitment to portfolio studies in 15/16 Three Dementia Practice Lead Facilitators are in place and will support staff in maintaining key dementia rater skills across Greater Manchester. studies and have successfully passed on their skills to more junior members of the team. 2.2 Contribution towards achievement of the 2015/16 NIHR CRN Clinical Research Specialty Objectives a) Please complete Appendix 1 to provide a report on performance against individual Clinical Research Specialty Objectives. b) Below, please provide a brief summary of overall performance against the Clinical Research Specialty Objectives, including: key achievements, successes and challenges, and where possible, reasons or an explanation for these. 15

16 In 2015/16 Greater Manchester maintained a strong consistent performance across all Specialties, in the main meeting the objectives that were set. Due to a 5% reduction in budget for 2015/ 16 the emphasis for CRN:GM was stability and increased flexibility of the workforce. Strong leadership emanating from the COO/CD and Divisional Leads ensured that this requirement was met by our partners across the Network as we strongly promoted and encouraged a one network approach. The greatest challenge in Greater Manchester remained the ability to support the smaller specialities with existing CRN resource and this powerful message of increased workforce flexibility enabled this to be achieved. As well as encouraging these developments within our partner organisations, CRN core team expansion took place when posts became vacant and this enabled the development of a centralised highly skilled workforce supporting the 6 Divisions which was led by a cohort of Senior Research Nurses and Clinical Studies Officers. These senior individuals had the requisite skills to support study delivery in any specialty if there were recruitment challenges or work within areas outside the Trusts which encompassed community and nursing/care home settings. This flexible workforce enabled similar levels of support to be given to individual specialties. In 90% of Clinical Research Specialties (this has increased from 70% in 14/15) GM ranked amongst the top 10 CRNs overall, making significant improvements within areas including haematology, ageing and HS & DR These improvements have been supported through the 4 RDM structure. In Greater Manchester each RDM has a cohort of Trusts that they support balanced with managing a number of clinical specialties This new system has been in place for 15 months and continues to work well. The relationships that have been established allow positive and open discussions with Trusts and research teams concerning study performance, capacity and capability.all specialties are making improvements either in terms of recruitment or through developments within their capability making optimum use of existing resources. This is underpinned by our extensive workforce training program that continues to maintain high levels of clinical research expertise across the region. For example, significant work took place within the stroke specialty throughout 15/16. At the Hyperacute Stroke Research Centre in Salford and following another successful HSRC review, the Emergency Medicine and HyperAcute Stroke Research Teams merged in order to support joint delivery of hyperacute studies and enable cross cover working. In addition, a reconfiguration of the delivery of hyper acute services in Greater Manchester offered a unique opportunity to deliver these complex studies in areas outside of the main Neuroscience Centre and the RDM/Lead Research Nurse in partnership with Senior Medical Leaders at the relevant Trusts facilitated the development of this new research infrastructure. Patients will start to realise these new research opportunities within 2016/17. In Children s, the neonates team took on their first piece of commercial research a study into reducing retinopathy in premature babies. Despite encountering a number of barriers during study set up and challenges with recruitment, the team remained committed making the team one of the highest recruiting centre in the UK. c) Please highlight any Specialties that have been the particular focus of investment locally in 2015/16 and comment on the return on this a investment. 16

17 Cancer remains the speciality receiving the largest investment across Greater Manchester with a 28% study share of the entire portfolio. Study numbers have remained high and there has been a slight increase in 15/16, although recruitment numbers have decreased from the previous year. Studies are becoming increasingly complex with the advent of personalised medicine delivered through more targeted therapies, however Greater Manchester continues to offer patients, with a broad range of tumour types, the opportunity to participate in research. The creation of the core team workforce hosted by CMFT has benefitted the dementia speciality. The team have the ability to move from site to site and identify patients within primary and secondary care as well as through links with the voluntary sector and charities via Join Dementia Research. Again dementia research remains an area of growth within GM, with a strong commercial arm of the portfolio beginning to emerge. In 15/16 primary care organisations have contributed approaching 6000 participants to CRN portfolio studies the majority of these studies are co adopted by primary care however this demonstrates the levels of engagement in research across the primary care community and the willingness to support high quality research. 17

18 Section 3: Report on performance against the LCRN Development and Improvement Objectives for 2015/16 (up to 2 pages) 3.1 Please provide details, and evidence of the impact of, local actions and activities undertaken in 2015/16 to promote equality of access, and ensure that wherever possible, patients have parity of opportunity to participate in research (not already covered elsewhere in the report) Workforce Development Team Consent in CTIMPs for non medics training: The objectives of this short, classroom based course are around working smarter and ensuring that opportunities for participation in research are maximised. Currently only utilised by one of our CRN Partners as there are differing perspectives around what represents risky behaviour. We consider that the pathway implemented by this Partner organisation mitigates the perceived risks and potentially enhances the patient/participant experience. Increasing Engagement and Research Delivery in Primary Care: GM Industry Team spent 3 months (Jan Mar 2016) looking at various models for research delivery, including individual practices, small groups of practices and with the development of federations, new models which would support practice collaboration and give research team access to large populations. Some of the newly formed federations had expressed an interest in developing capacity by member practices supporting and collaborating with some GM existing experienced primary care sites. Working collaboratively with the Primary Care Team, the Industry Team now have models of GP and primary care involvement at varying levels in each of the CCG areas in GM. Each CCG now has at least one key practice which have the capability to deliver commercial research studies to the same ability as a secondary care site (or has been identified and is in the process of being supported to achieve this level of knowledge and skill). These key GP sites are well supported by small clusters of GPs in that CCG area who are keen to work with that practice as a PIC site for commercial studies. Through this project there are also a number of other GP practices who are now engaged with research through the GM network. There has been an increase of primary care interest in academic studies and an increase in the number of GPs working with secondary care sites in GM to look at ways of working together to support patients access to research services. ENRICH Initiative: Following the successful delivery of the first care home study in the ENRICH Network has continued to grow and a further 10 care homes have signed up to be research ready. With a significant portfolio of projects within these areas being funded, opportunities for patients are growing and the team are looking to run their first clinical trial in this setting in Working with the care home sector demonstrates Manchester s commitment to equality of access. 18

19 3.2 Please provide a reflective commentary illustrating how your network has demonstrated a one Network approach to delivery (not already covered elsewhere in the report) The COO/CD operate a fully transparent, open door approach to the management of the Clinical Research Network in Greater Manchester. Through the Exec Group, Local Specialty Groups, Partnership Group, one to one Trust meetings, Speciality meetings and patient and public events there have been several opportunities throughout 2015/16 for the community across Greater Manchester to view our research activity and performance, discuss resource utilisation, understand pipeline and potential research opportunities. The RDMs in partnership with the Industry and RM & G teams have delivered a consistent and personal service to each of their Trusts and in 2015/16 our partner organisations have been fully committed to delivering high quality research across Greater Manchester working in collaboration in order to to achieve this they have been extremely open to sharing knowledge and ways of working, with Trusts actively encouraged to meet and learn from each other. An example of this is the Mental Health Trust Forum which has met every quarter the three mental health Trusts are brought together with meetings led by the Mental Health Specialty Leads. Topics have ranged from Excess Treatment Costs to struggling studies to patient and public events and have continued to be extremely useful for all parties. Workforce training has been available rotating across locations within the region throughout the year and the NIHR Induction package has begun to roll out for new CRN funded staff and will be part of the CRN:GM Continuous Improvement Programme in 2016/17. 19

20 Section 4: Report on performance against the CRN Operating Framework Compliance Indicators (up to 5 pages) 4.1 Please comment on progress against your plans for delivery against the Operating Framework requirements (as set out in Table 3 of your LCRN Annual Plan 2015/16) LCRN Governance Identified CRN risks have fed into the host organisation s risk register. There is an identified lead within the CRN who attends regular Trust Risk Meetings and feeds back to the CRN team. Arrangements remained in place during 15/16 for any public health outbreak and following an audit by the Trust in February 15, a further audit by the host organisation is planned. Research Delivery Due to delays in full HRA implementation the process of transition from RM&G to the Study Support Service began in earnest in January During the rest of the year the RM&G team continued to facilitate the CSP process whilst it was still operational and maintained a good service. In 2015/16 a reduced level of RM&G funding was still provided to partner organisations to do the same. From an industry perspective, the feasibility process was reviewed and improved in order to meet required timelines and partner Trusts continued to use the NIHR costing template. Delivering on the Government Research Priority of Dementia In 2015/16 our two Speciality leads supported our Dementias and Neurodegeneration activity and community. They have both attended national theme meetings and have both driven expansion of the GM portfolio within commercial and non commercial areas. Over 2000 participants have been recruited in 2015/16 surpassing our CRN goal. Join Dementia Research became fully operational in 2015/16 and approaching 50% of GM volunteers have been matched to studies which was recognised nationally. Patient and Public Involvement and Engagement (PPIE) There is an identified Senior Leader responsible for PPIE and progress against plans is shown in Appendix 2 Continuous Improvement (CI) There is an identified Senior Leader responsible for CI and progress against plans is shown in Appendix 3 Workforce, Learning and Organisational Development There is a senior leader with identified responsibility for LCRN workforce development who contributes nationally to the CRN Workforce group, playing a significant role within this and she has attended several workforce meetings within 2015/16. Detailed activities against plan are shown in Appendix 4. 20

21 Information Systems There is an identified lead for Information Management and Governance within CRN: GM who links with colleagues nationally across the CRN. LPMS implementation began in 2015/16 and partner organisations have received training on the system and this will continue in 2016/17. All other systems are operational and training sessions available to partners when required. Engagement and Communication CRN: GM In 2015 /16 communications delivery priorities were met and included significant work around engagement with our patients and the public, highlighting patient research stories, commencement of the development of the Patient Research Ambassador initiative and Building Research Partnerships facilitator training. Work focussed on the development of CRN:GM s social media presence was completed. Collaboration and communication with NIHR partner organisations within Manchester including CLAHRC and RDS enabled networking to a larger audience. Information Governance In 2015/16 CRN:GM continued to link with the host organisation and complete relevant staff mandatory training enabling high standards of good information governance relating to all areas of our activity. 4.2 Please complete the right hand column of the table below as requested against each of the 2015/16 Operating Framework Compliance Indicators Domain 1 LCRN Management Arrangements Objective A: Clinical Research Leads, Clinical Research Specialty Leads, Divisional Research Delivery Managers, Cross Cutting Team and Support Team are in post Please confirm if all posts were filled at 31/03/16 Yes No If you have responded No above, please identify which posts are vacant and comment on plans to fill these: 2 Research Delivery B: LCRN leadership and management groups are established (LCRN Executive Group, Clinical Research Leadership Group and Operational Management Group A: LCRN Partner organisations adhere to specific national systems, and Standard Operating Procedures and LCRN guidance in respect of research delivery All leadership and management groups continue to work effectively maintaining high levels of attendance at all meetings Please comment on progress and achievements against this objective focussing on the following areas: 21

22 a) Delivery of CRN Study Support Service according to national SOPs and guidance for both commercial and non commercial studies The HR Consultation surrounding the disbanding of the RM & G Service and the full implementation of the CRN:GM Study Support Service began at the end of 15/16 and will continue into the early part of 16/17. New Study Support Service job descriptions were appropriately reviewed and banded within the host organisation. National SOPs have been reviewed and the process of implementation has begun. b) Provision of support for LCRN host and partner organisations to apply the principles outlined by the CRN CC 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 In 2015/16 the HRA Change lead delivered several sessions to the CRN partner organisations across the region and this included a session delivered to the Specialty Group. A number of Trusts including the host Trust are ready to begin the capacity/capability assessments as required and the CRN will continue to work with these organisations to support them in this period of transition. B: Timely processing of study wide and local reviews with the CSP process (15 days respectively) In CRN:GM provided 161 study wide reviews with a median time to completion of 13 days and 93% of studies meeting the 15 day target. 815 local reviews were provided with a median time to completion of 8 days and 66% of studies meeting the 15 day target. Primary factor reducing the overall local review percentage was loss of resource from the most research active partner organisation. They have restructured their R&D support, leading to modest improvements in the second half of Performance is expected to improve further in

23 3 Stakeholder engagement and communications C: Support the delivery of the Government Research Priority of Dementia D: Develop a high level plan to improve research infrastructure through greater engagement of community pharmacy A: Promote research opportunities in line with the NHS Constitution for England, including informing patients about research conducted within the LCRN and actively involving and engaging patients, carers and the public in research B: LCRN communications function and delivery plans in place, and budget line identified Covered via completion of Section 2.1 Primary Care Specialty Lead and COO developed a new JD for a CRN community pharmacist and interviews were held at the end of March 2016 This role will work cross specialty supporting community focussed campaigns (Help Beat Diabetes /JDR) and communicating key research messages. Already covered via Section 5 / Appendix 2 Stakeholder relations Collaborative relationships built with Trusts Research and Development Managers and communications to cross promote research through communications channels. Maintained regular monthly communications for delivery across GM aimed at a variety of stakeholders. Events 17 events attended representing CRN 1 Research Awards event. Public relations Media contact list updated and contact made with 2 key local journalists (MEN & BEN), Press monitoring, newsletters, website. Social Media Supported key initiatives. I nternal Communications Update of CRN: GM office activity and clinical research related news. Presentation at R and D meeting, band 7 nurses meeting, Repository of patient /carer case studies and stories gathered, collated and utilised within communication activities wherever possible (2 case studies) 23

24 Branding NIHR Identity Guidelines Cascade branding materials to key stakeholders and ensure consistency of brand Online/Social media manage the CRN: GM microsite, including: news (e.g. first UK/European/global patient into a study, top recruiting site), case studies, resources, events, contacts, etc Worked with RDM s to Identify the areas (both clinically and geographically) of the network s operations that require communications and engagement support to improve the network s performance and agree on specific actions to focus efforts on. C: LCRN contribution evident in national NIHR/NIHR CRN campaigns Local elements of National Campaigns League Table Campaign Radio sell in and press, identified 2 patients for case study, promoted locally Obesity Campaign ( Size Matters) local press releases with localised quotes, signposted to splash site and case study contacts Mental Health Awareness Campaign. ICTD OK to Ask prepared patients and staff case study to strengthen messages and social media campaign to promote tweetchats and PSP s, MOOC promoted through communications channels, HSJ awards championed on social media and via partners websites. Patient Stories 3 case studies completed and published on website. NIHR at 10 comms guide cascaded to partner organisations internally and externally with key messages and activities to support campaign. Continue to liaise with Coordinating Centre, highlighting any opportunities with national media potential achievement. 4 Continuous Improvement Promote and sustain a culture of innovation and continuous improvement across all areas of LCRN activity to optimise performance LCRN to insert commentary on their performance and achievements in 2015/16 (unless already covered under Section 5 or Appendix 3) 24

25 5 Workforce, Learning and Organisational Development 6 Financial Management 7 Information Systems Develop and implement an LCRN Workforce development plan in partnership with relevant stakeholders and other local learning providers A: LCRN Host Organisation and LCRN Partner organisations must meet minimum control standards, as specified by the National CRN Coordinating Centre B: LCRN Host Organisation must meet minimum requirements for the scope of internal audit work, as specific by the National CRN Coordinating Centre A: LCRN Host Organisation and LCRN Partner organisations have access to the required information systems and services B: LCRN Host Organisation and LCRN Partner organisations have a Local Portfolio Management System(s) (LPMS) live and in operational use by LCRN funded staff Addressed via completion of Section 5 / Appendix 4 At the beginning of 15/16 an internal financial audit took place facilitated by CMFT. The systems were tested against the minimum control document and met requirements. Following the audit there were no significant findings and the resulting minor recommendations have been duly implemented. A. further audit will take place within 3 years For each system identified below please indicate whether the LCRN Host Organisation and LCRN Category A Partner organisations have access: CRN National systems Yes No NIHR Hub ODP 1 CSP * CRN Portfolio Database* If you have responded No above, please provide an explanation for each system or service which has not been accessible in 2015/16: LPMS live and in operational use by LCRN funded staff in the LCRN Host Organisation and LCRN Category A Partner organisations? Yes No 1* Noting that these will soon become legacy systems 25

26 If you have responded No above, please provide an explanation: 8 Information Governance LCRN Host Organisation and LCRN Partner organisations comply with CRN information governance requirements Already addressed via Section 1 26

27 Section 5: Report on performance against Patient, Public Involvement and Engagement, Continuous Improvement and Workforce 2015/16 plans (up to 2 pages) a) Please complete Appendices 2 4 to provide a report on performance against the network s 2015/16 plans for Patient, Public Involvement and Engagement (PPIE), Continuous Improvement (CI) and Workforce. b) If there are key achievements, successes or challenges that you wish to highlight from any of the above functions, please enter details below PPIE In 2015/16 Greater Manchester in collaboration with CRN: NorthWest Coast and the CRN CC successfully conducted facilitator training for the Building Research Partnerships Programme. This have given us a future mechanism to inform and educate patients and the public about ways they can and should be involved in research as we aim to strengthen and build partnerships at a local and regional level. The programme will also help researchers in developing and delivering quality research that is accessible, acceptable and patient focused to benefit patients and the NHS and it is anticipated that this may be integrated within our Study Support service offering in In 2015/16 Sasha s Trial a specially commissioned and collaboratively developed narrative developed by the CRN in partnership with Ziggy's Wish was launched a 30 minute open access film. This has proven to be a highly effective way of engaging members of the public in dementia and mental health awareness. Sasha s Trial depicts the relationship between Grandad, an elderly man who is living with dementia and Sasha, his granddaughter, who herself is experiencing mental illness symptoms in the form of low mood and deliberate self harm. The narrative is split into four segments the four seasons and throughout the 12 month period powerfully depicts the impact that the progression of Grandad s dementia has on their relationship and wellbeing. This was an example of how the arts and health came together in an engaging and powerful way to promote key relatable messages about health and health research to members of the public. The film has had over 800 views and was part of the national mental health Spotlight Campaign in February WORKFORCE Workforce Development Team Consent in CTIMPs for non medics training. The objectives of this short, classroom based course are around working smarter and ensuring that opportunities for participation in research are maximised. Currently only utilised by one of our CRN Partners as there are differing perspectives around what represents risky behaviour. We consider that the pathway implemented by this Partner organisation mitigates the perceived risks and potentially enhances the patient/participant experience. Workforce Development Team Hub Microsite for Core Clinical Staff. WFD Lead created Hub microsite in response to all clinical staff being clinically accountable to Host organisation s Lead Research Nurse. 27

28 The site holds both CRN; GM and Host information (such as alerts/induction/appraisal/hr policies) to ensure that our core team can be updated in any research site that will allow access to the NIHR Google platform and access essential documentation from one central place. Workforce Development Team collaborative event with D4 PI Recruitment Event PI Training Day. This event was repeated building upon our success in Reported upon within the CRN WFD National Steering Group as an example of best practice within this network. There are plans to replicate or utilise our experience within other networks. Workforce Development Team challenge. Understanding and meeting the needs of the Primary Care research workforce. This work began early 2016 and will continue as part of the WFD plan. A programme/pathway of support is being developed following a scoping/mapping exercise January March Workforce Development Team challenge. Understanding and meeting the needs of the Secondary care research workforce in essence the development needs of Research Practitioner roles are known and understood. However, this has not always translated into practice. Our plans to develop a Lead Nurse Community of Practice and begin to influence induction/management/appraisal is not as far in development as expected, so will be an on going project. 28

29 Section 6: Host Organisation report on performance against the LCRN Host Performance Indicators (up to 3 pages) 6.1 For each domain/objective, except where indicated otherwise, please comment on actions and approaches taken by the Host Organisation in 2015/16 to achieve the objective, the effectiveness of these actions/approaches, and any issues which have arisen. Domain Objective Host Organisation actions/approaches and any issues encountered in meeting/delivering against the objective in 2015/16 1 LCRN Leadership and Management Deliver effective leadership and management of the LCRN. The Host continued to be represented on the Executive team by the Medical Director Robert Pearson who continued to provide strong leadership. 2015/16 was a challenging year in terms of budget reduction coupled with proposed significant changes to organisations. For example Manchester Mental Health began the process of acquisition at the start of 2016 and this has impacted on clinical staff and teams. The Research team have worked extremely hard to continue to work with a positive mind set and support recruitment to studies. 2 LCRN Research Delivery Infrastructure Deliver a responsive and flexible NHS support service that meets the needs of researchers, funders and industry. The Study Support Service began to be configured in January 2016 and our RM & G staff began a process of HR consultation.roll out of the service will be completed in 16/17. The Host has put support in place for other Trusts that have been affected with vacancies. The Host has supported Stockport NHS Foundation Trust in the absence of an R&D manager. 3 Financial Management Deliver robust financial management using appropriate tools and guidance. Close collaboration between COO, RDMs, FM, IMT and Partner Organisations enabled the delivery of the Annual Financial Plan with a nil variance at year end. Reviews of Partners financial systems took place to confirm expenditure and AcoRD specialists reviewed Service Support requests to ensure compliance with guidelines. Host SFIs and procedures were incorporated from the inception of the LCRN. 29

30 Experienced financial support is available from the Host Trust and a representative attends the Executive meetings. Staff attrition rates and recruitment of suitably qualified and experienced staff and the impact on financial allocations remain challenging. This was, and continues, to be managed by vigorous forecasting and regular meetings at affected Partners. 4 Allocation of LCRN funding 5 LCRN Governance (Host Board) 6 LCRN Governance (Partner Engagement) Distribute LCRN funding equitably on the basis of NHS support requirements. Ensure that the LCRN Host Organisation board has visibility of LCRN business and fulfils its agreed assurance role. Ensure all LCRN Partners are engaged in the work of the Partnership Group. Performance data, local and regional knowledge of current and impending clinical research activity is assessed prior to the change to a Partner s allocation to ensure that the best use of funding is made. Attention is given to ensuring that R&D activity in Partners is not destabilised but support is placed where required and delivers value for money. Constant monitoring of allocations has meant that any slippage can be addressed appropriately and re distributed. Please confirm the number of occasions in 2015/16 when LCRN business was discussed by the Host Organisation Board and provide dates LCRN business was discussed at the Trust Board meeting in November The Medical Director attends the Host Trust Board and also the LCRN Executive meetings to ensure an appropriate exchange of relevant information. Please complete the following table to confirm the number of Partnership Group meetings held within the 2015/16 operational year and representation: Date of Meeting No. of attendees Of these the no. of lay attendees

31 Please 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 The group continued to be effective in 15/16 There is no lay representation on our group however through our Patient Research Ambassador Initiative, CRN activity/performance has been discussed and patient and public reviews always considered. 7 Management of Risk Establish and maintain an assurance framework and risk management system for the LCRN, including an escalation process. The LCRN continues to sit within the Research and Innovation divisional structure and risk management is managed and escalated as part of the Trust risk assurance framework for all divisions. This ensures escalation of significant risk to the Trust Risk Management Committee whose membership is comprised of executive directors and non executive members. There is an identified risk lead within the CRN. 8 Management of LCRN Performance Ensure delivery of LCRN performance against the LCRN Annual Plan. Partnership Board meetings have continued throughout 2015/16. The COO has had regular monthly meetings with the Director from R & I at CMFT. Activity, performance and any challenges/issues are discussed within this forum. Performance metrics are regularly reviewed at the Operational Management Group, Executive Group, Partnership Board and Specialty Lead meetings. Partner Organisations are engaged with the LCRN through meetings with the COO/CD/RDMs and Industry Team Performance is regularly reviewed and the CRN:GM awards present an annual opportunity to celebrate successes. 31

32 9 Host Corporate Support Services Deliver high quality Corporate Support Services as specified in the Performance and Operating Framework. In 2015/16 the Host has continued to provide a designated HR business partner who has supported in the preparation of the RM & G consultation. The CRN:GM Finance Manager works closely with the designated Finance lead from the host organisation. There is also designated IT support and facilities manager support. The LCRN has dedicated office space which can accommodate all of the Core team and office space for our flexible workforce where they can hot desk. The COO sits on the Divisional Management Board for the Research and Innovation Division to ensure full engagement in the Host organisation and access to required support. 32

33 Section 7: Other local innovation and initiatives (optional; up to 2 pages) 5.1 Please use this section to report on achievements for any other local innovation, initiatives or priorities in 2015/16 (not already covered elsewhere in the report). 2015/16 has been another successful year for CRN: GM and our patients. Some notable highlights are listed below and some further appendices which will be included with this report demonstrate and highlight other achievements across our region. DEVOLUTION MANCHESTER During 2015/16 the preparation continued for Devolution Manchester and the full transfer of powers took place on the 1st April As part of these new developments. Health Innovation Manchester (HInM) was launched at NHS Expo in September 2015 a new approach which is a landmark in the region s devolution of health and social care. The aim is to help create creating a world class health innovation system to speed up discovery, development and delivery of innovative solutions to help improve the health of people in Greater Manchester. HInM partners include CRN:GM, AHSN, Corridor Manchester, MSP and Connected Health Ecosystem. In January 2016 a Communications and Engagement Executive Sub Group was formed to develop a communications strategy and ensure it is aligned at senior level. The group will continue to oversee the activities and working relationships between organisations in support of HInM and develop a combined leadership and delivery model to allow the delivery of a place based communications and engagement plan. The CRN :GM Comms lead is part of this group. Northern Health Science Alliance The Northern Health Science Alliance Ltd (NHSA) is a new partnership established by the leading Universities and NHS Hospital Trusts in the North of England to improve the health and wealth of the region by creating an internationally recognised life science and healthcare system. Greater Manchester has had meetings and dialogue with the Northern CRN counterparts and expect the momentum to increase during PFIZER INSPIRE In 2015/16 GM:CRN became part of the Pfizer INSPIRE programme. Through INSPIRE, Pfizer and the Clinical Research Network are sharing expert knowledge and experience of medicines research, to help bring more clinical trials to Manchester and the wider UK in order to deliver the best results for patients in the NHS. CRN:GM s performance within this programme will be reviewed by Pfizer in May HSJ CLINICAL RESEARCH IMPACT FINALISTS In November 2015 the CRN: GM Division 4 research team attended the finals of the HSJ awards in London. The team was nominated for the creation of MHresearchMCR this is a collaboration of organisations across Greater Manchester (GM) which, through Division 4 of the Greater Manchester Clinical Research Network (GMCRN), has worked together innovatively to deliver a broad and deep portfolio of mental health research. At the core of the work, an extensive patient and public involvement (PPI ) and engagement programme drives our strategy, and our success. MHresearchMCR was established to create greater access to research for every person with mental health concerns across Manchester. Our ambition is driven by the conviction that everyone has a right to be included in research. 33

34 Appendix 5 CRN:GM Achievements 2015/16 Appendix 6 CRN:GM Clinical Research Awards Appendix 7 CRN:GM Key Statistics Appendix 8 CRN:GM LPMS R Peak Live Appendix 1: Report on network s contribution to achievement of the 2015/16 Clinical Research Specialty Objectives For each objective in Groups 1 3 please (a) enter the actions to achieve the objectives based on your 2015/16 Annual Plan, adding any additional actions taken as appropriate; (b) In the right hand column, please comment on your network s performance against your planned contribution in 2015/16. Where applicable, please include numerical data to illustrate performance against your local baseline where applicable and/or your network s contribution to the national CRN target. Please highlight approaches which have proven particularly successful and challenges encountered, and provide reasons or explanations where possible. GROUP 1: INCREASING THE BREADTH OF RESEARCH ENGAGEMENT IN THE NHS Increasing the opportunities for patients to participate in NIHR CRN Portfolio studies ID Specialty Objective Measure Targe t 1.1 Cancer Increase the opportunities for cancer patients to take part in research studies, regardless of where they live, as reflected in National Cancer Patient Experience Survey responses Number of LCRNs which have an action plan to increase access in each subspecialty (eg by opening studies, increasing awareness and forming referral pathways for access to research) LCRN actions to achieve objective(s) 15 Senior Research Nurse representation on the Pathway Boards of Manchester Cancer Centre and link in with the identified Research Leads. Contact information for all Research Teams to be included in pathway papers. Update Pathway Boards regarding commercial trials at each site and what support is available.reviewing the time to target and explore/discuss ways to address Performance against plan Senior Research Nurse associated with each Pathway board to support the Subspecialty Lead Quarterly reports produced for each pathway board Monthly Band & meetings held to review all new and open trials,share best practice and shared care issues discussed 34

35 any low recruitment and learn from successful trials.. Feedback to the cancer research team at monthly Band 7 research nurse meetings. Link in with the CNS teams at each site, and regular attendance at MDT meetings. Develop links with Primary Care, Mental Health and Palliative Care. Continue to use and expand the Shared Care process across the network IBIS 3 in set up has helped develop links with Primary Care 1.2 Children All relevant sites that provide services to children are involved in research Proportion of NHS Trusts recruiting into Children s studies on the NIHR CRN portfolio 95% There are portfolio studies at all hospital sites treating children and work will continue to maintain that engagement\support as well as placement of studies. Lead, DRM & Division 3 Senior Nurse to identify new NIHR Portfolio studies which can be placed & delivered within the LCRN. Maintain & strengthen established links with other specialities in particular Diabetes, Haematology, Respiratory, ENT, Infectious Diseases and Microbiology to continue to support & recruit to studies from a wide range of specialities providing greater opportunities 88% We have continued to have local specialty meetings which have been well attended from sites across GM. They have been an opportunity to discuss performance, discuss new/current studies as well as highlight the links the children specialty has with other specialties. The Division 3 lead nurse has been visiting sites on a regular basis to discuss any study issues and provide support to the paediatric nursing teams. The RDM, Lead nurse, industry team and speciality lead endeavour to identify 35

36 for Children to be involved in research. Work with the LCRN industry team to engage with industry in order to increase placement of studies at all LCRN sites, highlighting non commercial track record to sponsors as appropriate. new portfolio studies for GM and share with sites as appropriate. Industry team to work with Lead and RDM to develop the local cohort of PIs 1.3 Critical Care Increase intensive care units participation in NIHR CRN Portfolio studies Proportion of intensive care units recruiting into studies on the NIHR CRN Portfolio 80% Within CRN GM there are 12 intensive care units (this includes The Christie NHS Foundation Trust, however, their patients needing level 3 intensive care are usually scheduled to have their healthcare at other Trusts) of which 4 are actively recruiting intensive care units. In 2015/16 we have maintained good performance within critical care. Initiatives to improve this include: developing links to trainees within intensive medicine this project will be led by Jonathan Barnard Smith (Consultant at Central Manchester University Hospitals NHS Foundation Trust) and developing PCPIE project led by Tim Felton (Consultant in Respiratory and Intensive Care at University Hospital of South Manchester). 36

37 1.4 Dermatology Increase NHS participation in Dermatology studies on the NIHR CRN Portfolio Number of sites recruiting into Dermatology studies % of our provider sites already recruit into dermatology studies and we expect this will increase to 80% this year. We are seeking to engage with the remaining site and in particular district general hospitals to place more studies outside of the main dermatology centre. In 2015/16 Dermatology has engaged with 80% of our provider sites 1.5 Ear, Nose and Throat (ENT) 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% In 2015/16, four GM provider Trusts will be recruiting into ENT studies. Local efforts will be centred around an objective to develop this area within one of our large teaching hospitals (University Hospital of South Manchester). 45% GM appointed a new ENT specialty lead in the summer. The lead has been engaging with PIs through local specialty meetings and a newsletter which have been well received as well as encouraging the sites with regular correspondence. We have identified an ENT lead in each of the Trusts. We aim to continue this engagement in 16/ Gastroenterology Increase NHS participation in Gastroenterology studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting into Gastroenterology studies on the NIHR CRN Portfolio 90% 8 GM Trusts are currently recruiting to gastroenterology (72%). To achieve the 15/16 national target, the local objective will be to ensure that an additional two acute Trusts become actively involved in NIHR portfolio Gastroenterology studies. 82% In 2015/16 37

38 1.7 Haematology Increase NHS participation in Haematology studies on the NIHR CRN Portfolio Proportion of eligible NHS Trusts undertaking Haematology studies in each LCRN 50% Identify new NIHR Portfolio studies, both commercial and non commercial, which can be delivered within the LCRN, in particular the DGHs to increase Trust participation in haematology studies. Engage with industry to maintain & develop the commercial portfolio ensuring robust feasibility and consequently RTT. Engage with LCRN Industry team, in particular the Business Development Manager & Industry Operations Manager in order to generate new potential commercial business.. 44% During 15/16 GM has recruited patients to 15 haematology studies across 7 sites. Haematology have a strong commercial portfolio with 9 of the 15 studies being industry sponsored. The industry team continue to link well with the haematology teams undertaking commercial research. Although GM have not met the 50% target of Trusts undertaking haematology studies the overall patient recruitment for haematology studies in 15/16 has surpassed 14/15 and nationally they are ranked 2nd in 15/16 compared with 13th the previous year. 1.8 Injuries and Emergencies Increase NHS major trauma centres participation in NIHR CRN Portfolio studies Proportion of NHS major trauma centres recruiting into NIHR CRN Portfolio studies 100% All three major trauma units in CRN: GM currently participate in portfolio research and this is expected to continue in 2015/16. Additional studies are in the pipeline to continue recruitment All three major trauma units in CRN: GM have continued to participate in research in 15/ Injuries and Emergencies Increase NHS emergency departments Proportion of NHS emergency departments 30% Four CRN: GM emergency departments (36%) are recruiting in 14/15, currently meeting the CRN generic nurse has supported the BEST study at CMFT. 38

39 participation in NIHR CRN Portfolio studies recruiting into NIHR CRN Portfolio studies national target. The local objective is to engage further with Darren Walter (Consultant in Emergency Medicine and Trauma Lead at the University Hospital of South Manchester) and Laith Sultan (Emergency Medicine Consultant) to develop their activity. BEST study now open and recruiting in 14 A+E departments. 3M BRIGHT is open and recruiting in North Manchester. Several sites have new studies in the pipeline, including the BEST study and 3M BRIGHT Musculoskeletal Increase NHS participation in Musculoskeletal studies on the NIHR CRN Portfolio Number of sites recruiting into Musculoskeletal studies on the NIHR CRN Portfolio 300 We already have the maximum number of secondary care centres recruiting into MSK studies including our only AQP. We are working to expand MSK research outside into community and primary care services (mainly physio based care) and are working with Keele University MSK group to place studies in these settings. 26 Patients have been recruited to MSK studies across a range of secondary and community based settings. The Lead and RDM continue to engage with sites through visits, network specialty meetings, s and newsletters. The Lead and RDM have also been working with sites to increase the range of MSK studies, in particular orthopedic studies. Linking with the Surgical and Children s specialty to help ensure opportunities are not missed. 39

40 1.1 1 Ophthalmology Increase NHS participation in Ophthalmology studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting into Ophthalmology studies on the NIHR CRN Portfolio 60% Three Trusts recruited into Ophthalmology studies in 14/15. The local objective, with engagement through the Speciality, is to ensure a previously recruiting Trust recommences actively as well as developing three other GM acute Trusts. 36% Although we have not reached 60%, the number of Trust recruiting to ophthalmology studies has increased to 4 during 15/16. The Lead has created a database of research interested PIs at Trusts in GM to support engagement and placement of studies. Expanding the number of sites undertaking ophthalmology research continues to be a goal for 16/17. The Lead, RDM and Industry team presented at 2 seminars for ophthalmology registrars/trainees to promote research involvement Renal Disorders Increase the proportion of NHS Trusts recruiting into Renal Disorders studies on the NIHR CRN Portfolio which actively engage renal and urological patients in research Proportion of NHS Trusts recruiting into Renal Disorders studies on the NIHR CRN Portfolio which implement Patient Carer & Public Involvement and Engagement (PCPIE) strategies for Renal Disorders research 25% Both GM Renal Units currently meet this target therefore Work with the other Trusts undertaking renal disorders studies to consider how they can develop PCPIE strategies, linking with the already active Trusts for advice and support. To investigate what PCPIE initiatives already exist within the Trusts to see if they can be The majority of Renal disorder studies are undertaken within the 2 GM Renal Units which also see patients in satellite clinics within other Trusts. Both Units have PCPIE strategies in place. The other 4 Trusts which recruited to Renal Disorder studies do not have specific 40

41 utilised to support Renal Disorders Research PCPIE strategies in place for renal disorders research. However the number of Renal Disorder studies recruiting is much lower, 1 2 studies per Trust Stroke Increase the proportion of NHS Trusts, providing acute Stroke care, recruiting to Stroke studies on the NIHR CRN Portfolio Proportion of NHS Trusts, providing acute Stroke care, recruiting participants into Stroke studies on the NIHR CRN Portfolio 80% Currently 90% of NHS Trusts providing acute Stroke care are recruiting into NIHR portfolio studies. This activity will be maintained and expanded in as delivery of acute stroke services changes across Greater Manchester. Maintained recruitment in to NIHR portfolio studies within 90% of NHS Trusts providing acute Stroke care. There has been expansion of portfolio study activity in some Trusts with an increased activity at Stockport NHS Trust. The Specialty Lead and RDM are currently working closely with the one remaining Trust to ensure they are able to support NIHR portfolio studies in The appointment of Division 2 Lead nurse to support and facilitate research in Stroke has increased interest and support at Trusts level. Speciality Lead, RDM and Lead nurse have had talks with Royal Bolton Hospital Stroke team to start research studies in this area. The expected result of this support by the lead team will be to have all Trusts providing acute Stroke care delivering research studies within 16/17. 41

42 1.1 4 Surgery 85% Eight acute NHS Trusts (72%) are currently recruiting patients to surgery studies. The speciality will lead an initiative to involve an additional two District General Hospitals to ensure the 15/16 target is met. Target is now up to 82% Sub speciality leads now appointed, and regular meetings arranged. The Lead and RDM presented at a Clinical Research Update in Colorectal Surgery. Nurse appointed to support Vascular and ENT trials surgical at CMFT Increase NHS participation in Surgery studies on the NIHR CRN Portfolio Proportion of acute NHS Trusts recruiting patients into Surgery studies on the NIHR CRN Portfolio Surgical team at CMFT has expanded, now have 2 Clinical Trials Co ordinators. Trial portfolio extended in Vascular, ENT,Upper GI, Urology and Colorectal. Shared care studies supported and co ordinated across the Network, to ensure that patients have access to trials which will improve their outcomes. The RDM, Lead nurse and Speciality Lead endeavour to identify new portfolio studies and share with the sites. 42

43 GROUP 2: PORTFOLIO BALANCE Delivering a balanced portfolio (across and within Specialties) that meets the needs of the local population and takes into account national Specialty priorities ID Specialty Objective Measure Targe t 2.1 Ageing Increase access for patients to Ageing studies on the NIHR CRN Portfolio 2.2 Cancer Increase the number of cancer patients participating in studies, to support the national target of 20% cancer incidence 2.3 Cancer Increase the number of cancer patients Proportion of Ageing led studies which are multicentre studies Number of LCRNs recruiting at or above the national target of 20%, or with an increase compared with Number of LCRNs recruiting at or above the national target of LCRN actions to achieve objective(s) 50% We are working closely with a growing number of academics at all three local universities to encourage collaborations and help support the development of projects in older people, many of which will be multi centred. 15 The GM cancer research team have achieved the set recruitment targets for the past 7 years and this remains a priority for 15/16.Each trust is set a target to recruit 20% of their own cancer population into all studies and progress to achieve is will be discussed at the monthly band 7 meeting and any actions identified will be put in place. 15 The GM cancer research team have achieved the set recruitment targets for the past 7 Performance against plan 100% The Speciality Lead has established collaborative links with fellow academics across Manchester particularly within the fields of dementia and primary care, has linked with external groups including the Council and British Geriatric Society and has attended national meetings representing Manchester regularly. In 2015/16 recruitment to Type 1 has reduced to just over 16% however the Cancer Research Teams continue to work extremely hard to achieve this target It has been a challenging year as there have been a number of changes to 43

44 participating in interventional trials, to support the national target of 7.5% cancer incidence 7.5%, or with an increase compared with years and this remains a priority for 15/16.Each trust is set a target to recruit 7.5%of their own cancer population into all studies and progress to achieve is will be discussed at the monthly band 7 meeting and any actions identified will be put in place. We do acknowledge that the interventional target is a challenge for some of the DGH's to achieve therefore we plan monitor the number of patients identified at the trust MDT and referred to The Christie for recruitment into an interventional trial and locally acknowledge the recruitment service provision however the teams have still reached a target of 6.5% supported by the RDM, Lead Nurse and Specialty Leads 2.4 Cancer Deliver a Portfolio of studies including challenging trials in support of national priorities Number of LCRNs recruiting into studies in: Cancer Surgery Radiotherapy Rare cancers (cancers with incidence <6/100,000/year) Children's Cancer & Leukaemia and Teenagers & Young Adults 15 Cancer surgery Develop links with surgical teams, attendance at MDT meetings, link in with Division 6, develop a good knowledge of site specialities, send feasibilities as appropriate. Radiotherapy Use of shared care standard operating procedures, link in with Christie Teams. Rare cancers Children's Cancer & Leukaemia and TYA Established teams at The Christie and RMCH, both tertiary centres, Brightlights study open at other sites. In 2015/16 GM recruited to all 6 specialised areas 44

45 2.5 Cardiovascular Disease Increase access for patients to Cardiovascular Disease studies on the NIHR CRN Portfolio Number of LCRNs recruiting into multi centre studies in at least five of the six Cardiovascular Disease subspecialties 15 We have met this target in GM for 14/15 we will therefore continue to Identify and map existing and potential new CIs and PIs within GM LCRN identifying areas of interest in relation to the sub specialities. Identify new NIHR Portfolio studies from across the sub specialities which can be delivered within GM LCRN, in particular DGHs, and monitor progress quarterly. Speciality Lead and RDM to link with GM CRN Industry team in placing and identify new commercial CV studies which can be delivered across GM, providing robust feasibility to ensure delivery to time and target. GM has recruited into five of the six Cardiovascular Disease subspecialties as per ODP. GM appointed 2 new Leads in May/June The leads have been engaging with PIs through a local specialty meeting and site visits. They have worked with the industry team and RDM in identifying sites for commercial and noncommercial studies.the RDM and Leads also searched the portfolio database to identify studies which had the potential to be delivered by sites within GM and share information with sites as appropriate. 2.6 Diabetes Increase support for areas of Diabetes research where traditionally it has been difficult to recruit Number of LCRNs recruiting into diabetic foot studies on the NIHR CRN Portfolio 15 We have 3 centres actively recruiting into diabetic foot studies (we have a strong academic base in this area) and we fund a podiatrist post to help maximise recruitment at one of these sites In 2015/16 overall we have increased recruitment to diabetic foot studies and performance has remained strong throughout all quarters of the year. 2.7 Diabetes Increase access for people with Type 1 Diabetes Number of LCRNs approaching people with Type 1 Diabetes 15 We continue to develop capacity for diabetes studies in secondary care and will be working more There are now over 3000 people registered across Manchester through the Help 45

46 to participate in Diabetes studies on the NIHR CRN Portfolio early after their diagnosis to participate in interventional Diabetes studies on the NIHR CRN Portfolio within six months of their diagnosis intensively this year to increase recruitment in primary care and to ensure our resources are allocated to maximise potential in both settings. We are also focusing on expanding patient enrolment into the HelpBEAT diabetes consent for consent database. BEat Diabetes Campaign and they continue to matched to studies where appropriate. 2.8 Gastroenterology Increase the proportion of patients recruited into Gastroenterology studies on the NIHR CRN Portfolio Number of participants (per 100,000 population), recruited into Gastroenterology studies on the NIHR CRN Portfolio 15 Predicted recruitment for 15/16 is 362 which meets this national target. The local actions in meeting the predicted recruitment will ensure that the national target is met. 9 Trusts recruited to gastro studies. Recruitment has increased since 2014/15 but did not reach the planned target, however the suspension of the Chopin study has affected overall anticipated performance. 2.9 Genetics Increase access for patients with rare diseases to participate in Genetics studies on the NIHR CRN Portfolio Number of LCRNs recruiting into multi centre Genetics studies through the NIHR UK Rare Genetic Disease Research Consortium 14 The Greater Manchester Genetics team already meet the national measure, they will therefore continue Considering all appropriate, eligible new GM studies for approval via the NIHR Rare Genetic Disease Research Consortium. Consider participating in all appropriate NIHR Rare Genetic Disease Research Consortium approved studies. GM appointed a new Genetics Lead in the autumn. Greater Manchester continues to recruit into multi centre Genetics studies through the NIHR UK Rare Genetic Disease Research Consortium. This continues to be an aim for 16/17. The GM Genetics team have met with the industry team to looks at ways of increasing 46

47 Continue to work with the GM LCRN industry team to facilitate opportunities for industry funded intervention & non interventional studies. Continue to build on the capacity & capability for intervention studies by strengthening our links with the NIHR Clinical Research Facility & the Willink Inherited Metabolic Diseases team. commercial studies within the specialty and this continues to be a focus for the coming year, 16/17. The industry team continue to link well with the the Willink Inherited Metabolic Diseases team Haematology Increase access for patients to Haematology studies undertaken by each LCRN Number of LCRNs recruiting into studies in at least three of the four following Haematology subspecialties: Haemoglobinopathy, Thrombosis, Bleeding disorders, Transfusion 15 Increase LCRN engagement with GM Trusts regarding haematology studies. Maintain established links with other specialities in particular Injuries and Emergencies, Surgery, Children, Genetics. GM sites have recruited patients into all four of the haematology subspecialities in 15/16 as per OPD, maintaining links with other specialties, in particular Injuries and Emergencies, Children and the Genetics specialty Hepatology Increase access for patients to Hepatology studies on the NIHR CRN Portfolio Number of LCRNs recruiting into a multi centre study in all of the major Hepatology disease areas (including Viral Hepatitis, NAFLD, Autoimmune Liver Disease, Metabolic Liver Disease) 15 CRN: GM are currently achieving this objective in 14/15 and will look to increase UK PBC recruitment in line with national figures by resourcing increased recruitment from individual sites as well as increasing the number of sites involved with the study. Although similar study numbers there was a decrease in recruitment during 2015/16. The services in GM do not undertake research in all hepatology areas but the teams recognise the importance of offering research to this patient group 47

48 2.1 2 Infectious Diseases and Microbiology Increase access for patients to Infectious Diseases and Microbiology studies on the NIHR CRN Portfolio Number of LCRNs recruiting into antimicrobial resistance research studies on the NIHR CRN Portfolio 15 CRN: GM is recruiting into three commercial studies addressing various aspects of antimicrobial resistance in CDiff. This is expected to continue in 2015/16. We continued to successfully deliver good performance in this area CRN:GM continued to support Cdiff Studies in 15/16 and the commercial activity within this specialty outweighed the non commercial activity Metabolic and Endocrine Disorders Increase access for patients with rare diseases to participate in Metabolic and Endocrine Disorders studies on the NIHR CRN Portfolio Number of LCRNs recruiting into established studies of rare diseases in Metabolic and Endocrine Disorders on the NIHR CRN Portfolio 15 We have three centres with a strong academic base recruiting into the portfolio, and they lead their own studies and also recruit well into those led from elsewhere. We have a strong commercial portfolio in both endocrine and metabolic specialties and good engagement from local clinical teams involved with these rare diseases. The three main trusts have continued to recruit to both academic and commercial trials Oral and Dental Increase access for patients and practitioners to Oral and Dental studies on the NIHR CRN Portfolio A: Proportion of Oral and Dental studies on the NIHR CRN Portfolio recruiting from a primary care setting B: Proportion of participants recruited from a primary care setting into Oral and 20% Our Dental School already lead a number of multi centred studies delivering in primary care as their portfolio is health services focused and this will continue in future. 30% We already easily exceed this target locally but will continue to ensure we recruit via dental practices in our region. 100% All portfolio studies in 2015/16 recruited from a primary care setting 48

49 Dental studies on the NIHR CRN Portfolio 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% We are currently undertaking a GP engagement programme and have doubled the number of practices in receipt of CRN funding during 14/15 and plan to continue to develop capacity and infrastructure in practices. We have recruited new staff to support primary care delivery and will be adding to the team during 15/16. We are working closely with academic partners from all three local universities to help them appropriately develop projects in primary care and provide support for secondary care based teams who wish to recruit patients from primary care. We have appointed Community Pharmacy Champion and are also undertaking a similar programme of engagement in this setting. The CRN team delivered similar study numbers to 14/15 within primary care but these studies were smaller in sample size when compared with the previous year. Although where primary care is deemed the main specialty the proportion of studies is between 3 4%, as a co adopted specialty approaching 6000 participants have been recruited demonstrating the collaboration between colleagues and partner organisations across Greater Manchester The Pharmacy Champion came in to post at the end of 2015/16 and will work closely with the Primary Care Specialty Lead, RDM and CRN Team to enable pharmacy community engagement across GM Renal Disorders Increase NHS participation in Renal Disorders studies on the A. Proportion of acute NHS Trusts recruiting into multi centre Renal Disorders randomised controlled 30% Renal, Urology leads & RDM to Identify new Urology NIHR Portfolio studies which can be delivered within sites across GM, GM have a urology lead in post who has been engaging with sites through local network meetings and , discussing opportunities for 49

50 NIHR CRN Portfolio trials on the NIHR CRN Portfolio linking with other specialities such as surgery. Continue to engage with the LCRN industry team and national co ordinating centre to expand the commercial portfolio within the speciality across GM sites. new studies as well as ways to increase links with other specialties to expand opportunities for urology studies across GM. We now have a list of research interested PIs at most Trusts to help continue this engagement in 16/17. Linking with the industry team to increase commercial studies continues to be a focus for the specialty for both renal and urology studies. B. Proportion of Renal Units recruiting into multi centre Renal Disorders randomised controlled trials on the NIHR CRN Portfolio 80% The GM Renal Units both actively recruit to multi centred studies therefore RDM and Lead to investigate whether there are portfolio studies which satellite units within the LCRN can either act as a PIC or undertake studies themselves. Both Renal Units continue to actively recruit to multi centred studies, involving the satellite units as appropriate. The Renal units meet quarterly with the RDM, divisional lead and specialty lead to discuss renal objectives, local performance, study issues and new studies 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 the Respiratory Disorders main disease areas of 15 CRN GM currently participates in the disease areas Asthma and COPD. Historically, studies looking into Pneumonia sit with critical care. These are expected to continue in 2015/16. GM remained the highest recruiting Network enabling access to over 2000 GM patients to Respiratory Studies in 2015/16. The portfolio was again 50

51 Asthma, COPD or Bronchiectasis dominated by asthma and COPD Stroke Increase the proportion of patients recruited into Stroke randomised controlled trials on the NIHR CRN Portfolio A. Number of patients (per 100,000 population) recruited into Stroke randomised controlled trials on the NIHR CRN Portfolio 8 Monthly meetings between the Specialty Lead and RDM are in place to review performance and capacity across Greater Manchester to expand the Stroke portfolio RDM, Speciality Lead and Division Lead Nurse meetings will continue to review performance and disseminate study opportunities to Trusts. Interaction with University researchers early in the concept and protocol writing stage allowing use of expertise for deliverable studies is also being addressed Stroke Increase activity in NIHR CRN Hyperacute Stroke Research Centres (HSRCs) A: Number of patients recruited to Hyperacute Stroke studies on the NIHR CRN Portfolio in each NIHR CRN HSRC 50 Stroke Service reconfiguration across Greater Manchester will lead to greater numbers of stroke patients presenting to the site which should provide improved access for hyperacute studies. Performance management of the Salford HSRC will continue through its Team Leader and Clinical Lead Stockport NHS Foundation Trust as a hyperacute stroke centre has restarted recruitment to hyperacute studies, enrolling their first patient recently, after closing to all stroke studies early in Incorporating the Ambulance service into the NIHR portfolio studies of hyperacute stroke will increase the number of patients within that area. Progress has been made with a view to the Pasta 51

52 study opening in second quarter of 16/17. B: Number of patients recruited to complex Hyperacute Stroke studies on the NIHR CRN Portfolio in each NIHR CRN HSRC 15 The HSRC team supported by the Specialty Lead/RDM will continue to review the portfolio and look to expand the HSRC portfolio if capacity allows. The annual HSRC Review of SRFT took place in October 2015 where HSRC status was renewed. It was recognised that complex recruitment within the Centre had been good GROUP 3: RESEARCH INFRASTRUCTURE Developing research infrastructure (including staff capacity) in the NHS to support clinical research ID Specialty Objective Measure Targe t 3.1 Cancer Establish local clinical leadership and a defined portfolio across the cancer subspecialty areas Number of LCRNs with, for each of the 13 Cancer subspecialties, a named lead and a defined portfolio of available studies LCRN actions to achieve objective(s) 15 In collaboration with Manchester Cancer Centre 17 sub speciality leads have been identified.each lead is also the identified research lead for the Manchester Cancer Centre Pathways boards. The principal aim of this role is to ensure that Manchester Cancer and the Clinical Research Network has an active and successful portfolio of research, meeting the priorities and needs of the local population and contributing to the national research agenda. Performance against plan In collaboration with the Manchester Cancer Centre, CRN:GM have maintained 17 sub speciality leads throughout 15/16. 52

53 The research leads will be supported by an identified senior research nurse to provide a practical delivery perspective and attend the pathway meeting as required but at least twice a year. The core GMCRN team will provide the research lead with quarterly reports on recruitment to be discussed in addition an annual report will also be produced for both the Pathway boards and the acute trusts.the annual report will be used as evidence of research activity in the annual Peer Review process. 3.2 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 Number of LCRNs where Specialist Registrar networks are recruiting into NIHR CRN Portfolio studies 4 The GM Specialty Lead, Anton Krige, is to lecture to Specialist Registers at the North West Research & Audit Group (NWRAG). The lecture will focus on how to apply for a study grant. The plan is to generate interest in research amongst the Specialist Registrars. Anton will also be working to foster collaboration between the Anaesthesia Trainee Group & the North West Surgical Trainee Group. The potential for the Surgical Trainee Research Group to help with recruitment to??? 53

54 anaesthesia studies & vice versa for the Anaesthesia Group will be investigated re intra op data collection for surgery studies on the portfolio. 3.3 Dementias and Neurodegenerati on (DeNDRoN) Optimise the use of Join Dementia Research to support recruitment into DeNDRoN studies on the NIHR CRN Portfolio The proportion of people identified for DeNDRoN studies on the NIHR CRN Portfolio via Join Dementia Research 3% Join Dementia Research in Greater Manchester became operational in Q Project Lead will continue to communicate key information about the Join Dementia Research system to Trusts, clinicians and clinical teams involved in the delivery of dementia services across GM Project Lead will continue to facilitate JDR training with researchers and ensure that JDR is included as a recruitment tool within their research applications. A promotional campaign will continue to run in in partnership with the Mental Health and secondary care Trusts, primary care and main charities and through our PPI communities and networks. In 2015/16, 2 regional JDR Study Administrators and multiple Researcher Users have remained in their roles. Additional Study Administrator and Researcher accounts activated with training and continued support provided by the Regional JDR Project Lead. Project Lead has contributed to the redesign of JDR version 2 to help ease both volunteer and researcher user usability to maximise sign up. Project Lead performance manages regional use to evaluate volunteer and researcher use to efficiently identify potential matches. Regional Champions continue to advocate JDR and encourage volunteer sign up. 54

55 3.4 Dementias and Neurodegenerati on (DeNDRoN) Increase the global and psychometric rating skills and capacity of LCRN staff supporting DeNDRoN studies on the NIHR CRN Portfolio Proportion of LCRN staff who support DeNDRoN studies who have successfully completed Rater Programme Induction and joined the national Rater database 40% 3 Dementia Practice Lead Facilitators are in place to support the existing team of dementia raters across GM in order to ensure skills are maintained. If there are opportunities to enlist on rater training programmes, the network will put forward new staff in order to support the growing portfolio of dementia research. 65% In 2015/16 3 dementia PLFS have remained in their roles and dementia rating skills continue to be shared across the GM CRN team within Division 4. The cohort of raters has increased over the past year. Training records are kept up to date and some raters have received Industry accreditation. 3.5 Infectious Diseases and Microbiology Maintain research preparedness to respond to an urgent public health outbreak Number of LCRNs maintaining a named Public Health Champion 15 The CRN GM Public Health Champion is Andrew Ustianowski (Andrew.Ustianowski@pat.nhs.u k). CRN: GM Local Public Health Plans are in place and are accessible to staff via the NIHR Hub. The CRN GM Public Health Champion is Andrew Ustianowski ( Andrew.Ustianowski@pat.n hs.uk ) remains in place as are plans to respond to an urgent public health outbreak. 3.6 Mental Health Maintain and enhance the skills and capacity of staff supporting Mental Health studies on the NIHR CRN Portfolio in frequently used Mental Health Number of staff trained in frequently used Mental Health study eligibility assessments PANSS Practice Lead Facilitators are in place to support the existing team of raters across GM in order to ensure skills are maintained. Working with the academic teams at the University of Manchester, a training package of frequently used assessments is in place to support the local 3 PANSS Practice Lead Facilitators have remained in their roles and have contributed to national training updates during 2015/16. Skills have continued to be shared at events over the past year with the wider tea, and delivery staff have been encouraged to train to deliver 55

56 study eligibility assessments (e.g. PANSS, MADRS, MCCB) workforce in GM and this will be delivered to staff in MH assessments where possible. 3.7 Neurological Disorders Increase clinical leadership capacity and engagement in each of the main disease areas in the Neurological Disorders (MS; Epilepsy and Infections) Specialty Number of LCRNs with named local clinical leads in MS; Epilepsy and Infections 15 Named Leads for MS and epilepsy are already in place. In 15/16 the Network will identify a lead for Infections Overall the Neurological Disorders Lead represents all three specialties nationally however we have significant expertise within epilepsy. In 2015/16 the MS and Epilepsy portfolios have remained strong and an increase in MS Consultants at the Neuroscience Centre has increased the capacity within this field. 3.8 Reproductive Health and Childbirth Increase engagement and awareness of the Reproductive Health and Childbirth Specialty Number of LCRNs with a named midwifery lead to increase engagement and awareness 15 Continue to support & develop the role of the two GM midwifery champions, ensuring active engagement with clinical colleagues at a local level for both obstetrics and gynaecology studies. Work closely with the LCRN industry team, national co ordinating centre team and local clinical teams to increase the numbers of We have had two midwifery champions in place for the majority of the year who have engaged nationally as well as locally through the specialty meetings and a newsletter. One of the champions has recently changed job roles we will therefore be looking for a new person to take on the role in 16/17. Working with the industry team in identifying commercial studies for the specialty and supporting 56

57 commercial studies across the specialty. Continue to promote the excellent local track record in non commercial studies to commercial sponsors to increase the number of studies placed at LCRN sites. Undertake a local scoping exercise to Identify, encourage and assist specialty related contacts in undertaking feasibility assessments and expressing interest in studies at LCRN sites. feasibility/site selection has continued to be a focus. The RDM, Lead and divisional lead research nurse have visited sites throughout the year to discuss current studies and potential for new studies. GM appointed a new lead to the specialty in February. Appendix 2: Report against the network s Patient, Public Involvement and Engagement Plan 2015/16 57

58 Please complete the table below with (a) details from your Annual Plan for 2015/16, adding details as needed for any additional actions undertaken; (b) In the right hand column, please comment on your network s performance against your plan for 2015/16. Please highlight approaches which have proven particularly successful and challenges encountered, and provide reasons or explanations for these where possible. Planned actions in PPIE strategy and action plan to be approved Implement the GM: CRN PPIE action plan see attachment Milestones and outcomes once actions complete PPIE Strategy for 2015/16 and associated action plan approved by the CRN Executive and Partnership Group Timescale Lead Performance against Plan Completed Janet Eastwood/ Angie Parker Actions completed April 2016 Janet Eastwood/ Angie Parker/ Mary Speake Action Plan approved Strong communication strategy was interlinked with PPIE strategy. In 2015/16 Building Research Partnerships (BRP) Training was introduced to the region working with relevant organisations including CRN: NWC, MAHSC, CLAHRC, RDS, Patient Safety and NW People in Research. The GM Patient Research Ambassador Initiative is in development and will link closely with our BRP training. Provided effective and regular communication with the Co ordinating Centre via representation on their PPIE group and through ongoing dialogue. Also met with others to build up landscape of GM. Awareness event was held on the 24th November and 2 BRP workshops held 12 Feb and 27 April (2016) in collaboration with NWC and WorkForce 2 Please insert any additional actions undertaken, as required 58

59 lead. Video of the day available on YouTube Coordinate International Clinical Trials Day/OK to ask 2015 Campaign Link with Comms Teams across GM to support Trust activity through attendance at event/provision of materials Completed Janet Eastwood Coordinated activity and national plans were shared with Trusts. Support was given to Trusts with information on materials, branding and timescales. 10 Trusts took part throughout the week with events, social media, news items, press releases (national and local). Worked with RDM s supporting all PPI events Scope NHS Trusts across GM to understand current roles held by patients i.e Existing Patient Research Ambassadors (PRA s) Review recruitment methods, job descriptions, training provision and payment policy in existence at partner Trusts April 2016 Janet Eastwood Initial scoping of existing PPIE activities within GM took place in order to understand current best practice which has been or is being carried out and identify gaps across the network 16 Trusts were sent initial survey and 11 responded. 15 generic groups and 4 patient representatives identified. Disseminate examples of good practice and if no PRA s, support GM NHS partner organisations to recruit at least 2 per trust Supported Trusts and partner organisations to recruit PRA s through sharing of information via our communications channels. This included attending events, case studies published (2 last year) and stakeholder engagement with PPI leads at CLAHRC, GMAHSN, MAHSC, RDS, and partner trusts. 59

60 Continue to support Divisional PPIE activities and support/promote events Support key national campaigns including #Whywedoresearch and Join Dementia Research Evidence of an increase in volunteers registering Evidence of Comms campaigns leading up to and following PPIE events (social media, press releases) Ongoing Janet Eastwood PPIE lead supported by RDM s Supported national campaigns including JDR over 500 volunteers registered in 2015/16 ; Patient stories ; NIHR at 10; Spotlight Campaign (Young People/Mental Health) ; GM CRN/Ziggy s Wish Sasha s Trial Online open access film was launched and available on Youtube 789 views (Up to April 2016) 91eF8 Bolton research open day (8 Sept) Patient engagement event Hemophilia (19 May), Salford Research week (13 Aug), Let s ask about research Bolton (8 Sept), PPI Presentation The Christie (11 Dec) Develop stronger PPIE presence on GM:CRN website GM CRN PPIE microsite will signpost resources for GM patients and will be linked with key PPI stakeholder websites Completed Janet Eastwood Microsite on main CRN website has been further developed and public inv olvement ppi/ Links to local and national resources including INVOLVE and other partner organisations 60

61 Appendix 3: Report against the network s Continuous Improvement Plan 2015/16 Please complete the table below with (a) details from your Annual Plan for 2015/16, adding details as needed for any additional actions undertaken; (b) In the right hand column, please comment on your network s performance against your plan for 2015/16. Please highlight approaches which have proven particularly successful and challenges encountered, and provide reasons or explanations for these where possible. Planned actions in Report on mapping R&D Trust Service Improvement interfaces Milestones and outcomes once actions complete Report Sept 2015 Originally IOM but lead by CCO and RM&G Team Timescale Lead Performance against Plan RM&G Team supported the successful local transition of governance services to the HRA. The COO linked with Trust R&D departments to ensure research set up services locally were maintained for GM. LEAN SixSigma projects Reports evidenced improvements July 2015 IOM The IOM attended the Lean SixSigma training and has the skills the analyse and support continuous improvement projects locally. Engagement with national C.I. group Ongoing developments dissemination Ongoing IOM IOM engages with the NIHR CI national group to share best practice and shared learning opportunities. Development of Speciality Specific projects Evidenced improvements in processes April 2016 Originally IOM but led by Business The Business Development Manager led the Primary Care Engagement initiative, with the RDM and IDL. This led to a structured Primary Care model which 3 Please add any additional actions as required 61

62 Developm ent Manager supports the delivery of NIHR studies outside of secondary care environments. Joint C.I. training with CRN: North West Coast Trained Workforce April 2016 Originally IOM but led by Workforce Developm ent Lead RN GM Workforce Development Lead works with North West Coast to build a North West Training programme with shared events. This allows staff from both areas to access the same quality of training across both CRN areas. Recording on CRN Central C.I. website Promotion/sharing of GM C.I. activity Ongoing IOM and Communi cations Manager The Communications Manager shares all GM news via the web pages and monthly updates. The IOM has links with the national CI leads for each area and they manage the Central CI webpages. 62

63 Appendix 4: Report against the network s Workforce Plan 2015/16 Please complete the table below with (a) details from your Annual Plan for 2015/16, adding details as needed for any additional actions undertaken; (b) In the right hand column, please comment on your network s performance against your plan for 2015/16. Please highlight approaches which have proven particularly successful and challenges encountered, and provide reasons or explanations for these where possible. 4 Planned actions in Each network to complete based on their Annual Plan Milestones and outcomes once actions complete Each network to complete based on their Annual Plan Timescale Lead Performance against Plan Each network to complete based on their Annual Plan Each network to complete based on their Annual Plan LCRN to complete To establish Trust/CRN GM lead research nurse group Shared policies/protocols and a communication strategy between Trusts/Core CRN: GM on WFD related issues April 2016 WFD Lead A Lead Nurse Community of Practice has been agreed in principle but the first meeting is scheduled in June To further embed CRN GM induction pathway as a standard for CRN GM supported study delivery staff. Shared practice Ongoing WFD Lead This is on going we have updated the pathway to include additional training at later timepoints than induction (3 6 month period). Additionally when other NIHR supported research practitioners make contact to access our training 4 Please add any additional actions as required 63

64 programme, we share and encourage use of our induction package to enable them to be able to meet course learning objectives. To continue to work with Trust Lead nurses and R&D managers to assess the training needs of their workforce. Extension of the "Essentials" range for Research Practitioners to include refresher events involving experienced staff. Ongoing WFD Lead The Research Practitioner Essentials Course continues to be accepted as essential to a novice s research career. The course itself is continually updated to ensure it is current and receives consistent feedback, providing excellent value for investment. WFD Lead was a member of the CRN CC Working Group for developing a NIHR CRN Branded Fundamentals of Research programme. This lead to de prioritising refresher events as these would be included as part of the new programme. This national work has now been postponed until To provide bespoke training according to the needs of the workforce ie. consent in CTIMPs for non medics. Evidence of appropriately trained workforce Ongoing WFD Lead PI Training/Recruitment Division 4 have built on the success of 2014 by adapting this programme to focus on the needs of the potential PI. Experience has been shared nationally via WFD Leads Group. Consent in CTIMPs our Host organisation have now embedded this programme into their Standard Operating Procedures & Governance Procedures. Other CRN Partners are yet to make this controversial yet smart working move to extend the role of the non medic in CTIMPs. Buddy Training this short course (classroom based) has been through a pilot phase in and can now 64

65 be offered in any of our partner organisations that standardise research practitioner induction. To introduce/establish the following training events to the current programme: (i) communication skills course "Let's Talk Trials" (ii) working in the CRN (iii) a range of bite size events mixture of face to face/elearning) relating to Working with the Life Sciences Industry (iv) a range of bite size events (mixture of face to face/elearning) relating to the role of Principal Investigator Evidence of appropriately trained workforce Ongoing WFD Lead (i) Let s Talk Trials facilitator development has been suspended. No CRNGM facilitators established as yet. (ii) Working in the CRN this short course (classroom based)is evaluated very highly. Initially a NIHR CRN CC course, CRNGM have adapted the content and now deliver 6 8 weeks to a small group of people who wish to understand more about how working in the network can benefit their patients/service. (iii) Life Sciences Industry CRNGM industry facilitators offer team support sessions, plus have input into our Essentials course to ensure all research is conducted to the same standard. They have also been involved in delivering bite sized sessions within Specialty meetings/seminars. (iv) Have begun to develop a range of training/support for PIs and Primary Care this range will cover the knowledge gap between becoming interested in delivering research and GCP level understanding. PI Training Suite of 3 sessions from CRN CC was planned for release in The third session planned has been released for implementation. CRNGM will now lead on completing the work 65

66 initiated by CRN CC WFD and develop and pilot an introductory session, in close collaboration with CRN NENC as they are piloting a session 2. To work with change Champions to ensure anyone who needs access to the training we provide has a NIHR Google Hub account. NIHR LMS will move over to Google Hub in this financial year. Evidence of appropriately trained workforce October 2015 WFD Lead / Comms Manager Work continues. Some Partner organisations will not allow NIHR google platform access, some allow only access to NIHR CRN Learn. All research staff are offered the opportunity to request a NIHR address and are encouraged to use the Hub whenever relevant ie. GCP facilitators have to use the Hub to access course materials. To set up and complete a simple Training Needs Analysis in May 2015 which can then be repeated annually to inform the WFD team of Trust vs individual needs More accurate information on training requirements May 2015 WFD Lead NIHR CRN CC did create a TNA for local use. It was implemented by CRN GM but had an extremely poor response. This activity was then put on hold in this financial year a neighbouring network performed a large scale workforce review. The results are available for CRN GM to utilise and will help inform a review within as part of that plan. 66

67 Central Manchester University Hospitals NHS Foundation Trust, North Road, Manchester, M13 9WL Contact us Tel: Web: 67