NIHR Guideline B01 R&D Operational Capability Statement

Transcription

1 NIHR Guideline B01 R&D Operational Capability Statement Version History Version number Valid from Valid to Date approved Approved by Updated by RDOCSv1 Contents Organisation R&D Management Arrangements Organisation Study Capabilities Organisation Services Organisation R&D Interests Organisation R&D Planning and Investments Organisation R&D Standard Operating Procedures Register Planned and Actual Studies Register Other Information Organisation R&D Management Arrangements Information on key contacts Organisation Details Name of Organisation City Hospitals Sunderland NHS Foundation Trust R&D Lead / Director (with responsibility for reporting on Mr Kim Hinshaw, Consultant Obstetrician and Gynaecologist, Director of Research and Development R&D to the Organisation Board) R&D Office details: Name: Department of Research and Development Address: Room D1506, First Floor, The Education Centre, Sunderland Royal Hospital, Kayll Road, Sunderland Contact Number: ext Contact lynne.palmer@chsft.nhs.uk Other relevant information: City Hospitals Sunderland NHS Foundation Trust includes; Sunderland Royal Hospital, Sunderland Eye Infirmary and outreach centres/clinics including Monkwearmouth Hospital and The Galleries Health Centre. Key Contact Details e.g. Research Governance Lead, NHS Permissions Signatory contact details Contact 1: Role: Name: Contact Number: Contact Research and Development Manager Lynne Palmer ext lynne.palmer@chsft.nhs.uk Contact 2: Role: Name: Contact Number: Contact Data Manager Robert Smallcombe ext robert.smallcombe@chsft.nhs.uk Contact 3: Role: Name: Contact Number: Contact R&D Business Manager Ruth Turner ext ruth.turner@chsft.nhs.uk Research and Development Operational Capability Statement v1 1 City Hospitals Sunderland NHS Foundation Trust

2 Information on staffing of the R&D Office R&D Team R&D Office Roles (e.g. Governance, Contracts, etc) Whole Time Equivalent Comments indicate if shared/joint/week days in office etc Director of R&D 0.2 Mr Kim Hinshaw MB BS FRCOG, Consultant Obstetrician & Gynaecologist. Contact: R&D Manager 1 Data Manager 1 Lynne Palmer (R&D Manager), Financial Management, Governance Approvals, Risk Assessment, Quality Assurance, Feasibility, Contracts, Management of Clinical Research Staff and R&D Office Staff, Liaison with Senior Managers and Executives, Liaison with external Health care organisations, Sponsor Organisations, Universities. General Management of R&D Services, Promotion of research culture within the organisation. Robert Smallcombe, Assists with the governance check process for Portfolio/CSP Portfolio and non-portfolio studies, Liaison with PI and Research Team members, Liaison with Trial co-ordinators, R&D Form and SSI Form facilitation. Provides data management assistance to wider Trust. R&D Officer 1 Trish Storey, Creates, develops and maintains office systems (paper and electronic), Creates, maintains and amends databases to record progress of projects, Co-ordinates the research studies process, Liaises with PI/CI/Trial Co-ordinators, SSI and R&D form facilitation. R&D Administratror 1 Mary Crane, Co-ordinates the research studies process, Liaises with PI/CI/Trial Co-ordinators, SSI and R&D form facilitation, Co-ordinates meetings, diary dates etc., Minutes of the Research Governance Group and Executive Group. Information on reporting structure in organisation (include information on any relevant committees, for example, a Clinical Research Board / Research Committee / Steering Committee.) Reporting Structures The Trust is a member of the Northumberland and Tyne and Wear Comprehensive Local Research Network. The Trust has an Executive Group, which exercises business and contract/performance management functions, meeting biannually. There is also a Governance Group, which exercises research governance functions on behalf of the Trust, meeting two weekly, and has clinical, allied health professional, organisational representative and service support membership. All decisions on sponsorship of research are referred to the R&D Manager/Director of R&D, in order to facilitate more rapid grant of permission in straightforward cases. The Director of R&D submits an annual report to the Trust Board on behalf of the R&D department Information on Research Networks supporting/working with the Organisation. Information on how the Organisation works with the Comprehensive Local Research Network (CLRN), Primary Care Research Network (PCRN), Topic Specific Clinical Research Networks (TCRN). Research Networks Research Network (name/location) Northumberland and Tyne and Wear Comprehensive Local Research Network Stroke Research Network Diabetes Network Dementia and Neurodegenerative Diseases Research Network Primary Care Network National Cancer Research Network Role/relationship of the Research Network eg host Organisation As a CLRN member, the Trust employs, with CLRN funding, 3 core generic research nurses and 1 clinical trials officer and supports additional nursing/administrative staff working in various support departments and specialties. Specialties served at present are Respiratory, Rheumatology, Cardiology, Opthalmology, Urology, Gastroenterology, Renal, Neonates and ICCU. The R&D Manager is consulted during the RSS Study Planning process for all new clinical trials of investigational medicinal products (CTIMPs) being introduced to the Trust and for all other substantial studies requiring support. This ensures both robust feasibility, and, that workload is managed such that it is possible for the Trust to provide the necessary support for additional studies. The Trust host the North East Stroke Research Network. NESRN funded research nurses support stroke trials within the Trust, led by Mrs Penny Williams, Stroke Network Manager. The Trust is supported by a research nurse, employed by the Diabetes Research Network. Cross cover is provided by the core generic research nursing team. Sessional support is provided to the Parkinsons Specialist Nurse to provide research input within the Trust. Collaborative work is undertaken with the local Primary Care Network, aiming to facilitate both joint initiatives and rapid assessment of Participant Identification Centre identification. The Trust hosts an NCRN-supported clinical trials officer and administrative staff support to cancer studies across the Trust; with the NCRN Co-ordinating Centre providing additional portfolio management and training support to the wider cancer team. Research and Development Operational Capability Statement v1 2 City Hospitals Sunderland NHS Foundation Trust

3 Information on collaborations and partnerships for research activity (e.g. Biomedical Research Centre/Unit, Other NHS Organisations, Higher Education Institutes, Industry) Current Collaborations / Partnerships Details of Collaboration / Organisation Name Contact Name address Partnership (eg Contact Number Sunderland University R&D are developing collaborations with Sunderland University, particularly within the field of Pharmacy and drug development. Kath Griffin - early liaison kath.griffin@chsft.nhs.uk Newcastle University CHSFT regularly contribute to work delivered by the University by virtue to joint initiatives and grant applications including CHSFT personnel. Prof John Simpson j.simpson@newcastle.ac.uk North East Design Service The Trust recommends researchers access services available through the North East Research Design Service. However this must be undertaken in partnership with R&D in order that early feasibility is addressed, and finance support and management is achieved. Prof E McColl e.mccoll@newcastle.ac.uk Innovations North The Trust work in partnership with Innovations North in maximising Intellectual Property. Anna Taylor anna.taylor@nhsinnovationsnorth.org.uk Organisation Study Capabilities Information on the types of studies that can be supported by the Organisation to the relevant regulatory standards Types of Studies Organisation has capabilities in (please tick applicable) CTIMPs Clinical Trial of a Other Clinical (indicate Phases) Medical Device Studies Human Tissue: Tissue Samples Studies Study Administering Questionnaires Qualitative Study OTHER As Sponsoring Organisation x x As Participating Organisation Phase 3 onwards As Participant Identification Centre Phases 1-4 Which licences does the organisation hold which may be relevant to research? Organisation Licences Licence Name Licence Details Example: Human Tissue Authority Licence Human Tissue Authority Licence HTA Licence, for the procurement of tissues and/or cells intended for human application, designated individual Mr Barry Shaun O'Brien, Consultant Orthopaedic surgeon. Licence Start Date (if applicable) 11/03/2011 Licence End Date (if applicable) until revoked Research and Development Operational Capability Statement v1 3 City Hospitals Sunderland NHS Foundation Trust

4 PCT ONLY: Information on the practices which are able to conduct research Number/notes on General Practitioner (GP) Practices Organisation Services Information on key clinical services contacts and facilities/equipment which may be used in studies for supporting R&D governance decisions across the organisation. Clinical Service Departments Service Department Specialist facilities that may be provided (eg number/type of scanners) Contact Name within Service Department Contact Contact number Laboratory Medicine Pharmacy Range of laboratory services available - Microbiology/Clinical Biochemistry/Haematology, Transfusion and Immunology/ Histopathology/Cytology Clinical Trials Team within Pharmacy - Principal Pharmacist, Clinical Trials Co-ordinator and Administrative support. Dr Anura Kalansooriya Rod Beard Principal Pharmacist Anura.Kalansooriya@chsft.nhs.uk rod.beard@chsft.nhs.uk Details of any internal agreement templates and other comments For any study requiring involvement of the Trust's Laboratories Dr Kalansooriya is consulted during the RSS Study Planning process. The Trust aims to complete the Study Planning process quickly and Laboratory Medicine commit to giving speedy responses to requests for protocol assessment from the R&D department. This contributes to the overall assessment the R&D team undertake. The Principal Pharmacist is consulted during the RSS Study Planning process for all new CTIMPs being introduced to the Trust and for any other studies requiring Pharmacy Department support. The Trust supports a significant CTIMP portfolio and introduction of new studies requires early assessment of storage and any other capacity requirements. The overall Pharmacy team consists of GCP trained clinical trial pharmacists and technicians. Expertise includes clinical trial IMPs, IMP receipt, storage, reconciliation and disposal. This includes aseptic preparation of IMPs. Environmental monitoring ( temperature), dispensing to protocol, stock control, and re-ordering, labelling, re-labelling, monitoring, audit visit support is undertaken within the Department. Clinical trial pharmacy SOPs, and clinical trial pharmacy files, documentation storage and retention are regularly updated and maintained. There is a research lead pharmacist (GCP trained), and a cancer lead pharmacist (GCP trained). All 3 pharmacies have either GCP trained pharmacists or technicians. All pharmacists receive some clinical trial training. Clinical trials can be supported at Sunderland Eye Infirmary, and at Sunderland Royal Hospital, and if required, at outreach sites ( e.g. Washington). Research and Development Operational Capability Statement v1 4 City Hospitals Sunderland NHS Foundation Trust

5 Radiology The Trust has a range of facilities including Digital Plain Film X-Ray, 2 MRI scanners (1 mobile and 1 fixed), 3 CT scanners ( 1x64 slice, 1x128 slice and 1x mobile), a digital catheter lab, interventional facilities, digital mammography, a number of ultrasound machines. We also provide fluroscopy and have access to nuclear medicine imaging as required. Scott Elwell DGM scott.elwell@chsft.nhs.uk For any study requiring involvement of the Trust's Imaging Services the Directorate Manager is consulted during the RSS Study Planning process. The Trust aims to complete the Study Planning process within days and Radiology commit to giving speedy responses to requests for protocol assessment from the R&D Unit. This contributes to the overall assessment the R&D department shares with Sponsors and others concerned, identifying any operational risks and plans for dealing with them. Information on key management contacts for supporting R&D governance decisions across the organisation. Management Support e.g. Finance, Legal Services, Archiving Department Specialist services that may be provided Contact Name within Service Department Contact Named archivist within R&D department; archiving governed Archiving by Standard Operating Procedure; Lynne Palmer storage contracted to external lynne.palmer@chsft.nhs.uk specialist provider with facilities and systems. Contracts All research contract negotiations and signatures are managed by the R&D department. The use of national model agreements is very strongly encouraged; use of nonstandard draft agreements is likely to cause delay. Sponsors requiring Confidentiality Agreements to be in place before providing the Protocol are asked to approach the R&D department so that an agreement can be made allowing all relevant staff in the Trust to see the Protocol; agreements limiting protocol access to the proposed PI do not allow RSS Study Planning to be carried out and are not acceptable. Early liaison with Finance is always arranged Lynne Palmer lynne.palmer@chsft.nhs.uk Contact number ext ext Details of any internal agreement templates and other comments Statistical software is available in the Trust (SPSS). Please contact R&D in the first instance. Data management support Statistical support may be sought from Sunderland, Newcastle or Lynne Palmer lynne.palmer@chsft.nhs.uk ext Durham Universities and it is recommended researchers access the Research Design Service. Research and Development Operational Capability Statement v1 5 City Hospitals Sunderland NHS Foundation Trust

6 Finance The Trust has a Finance Manager with dedicated responsibility for R&D; in addition Finance Managers with responsibility for clinical and support directorates are involved in all financial arrangements; contact via R&D. Lynne Palmer lynne.palmer@chsft.nhs.uk ext The Trust has a Systems and Network Services department, responsible for managing all Information Technology systems and data security; data is Simon Joyce stored on secure servers with Simon.Joyce@chsft.nhs.uk disaster recovery plans etc. appropriate for clinical trial data; contact via R&D. The Trust's Information Governance team liaise closely with R&D, with a member of the IG team sitting on the Research Governance Group to provide Information Governance access to guidance on local Louise Mitchell louise.mitchell@chsft.nhs.uk protocols to ensure research applications comply with local protocols as well as with national law and guidance on data protection. Honorary contracts for research, and letters of access, are issued by HR in close collaboration with HR R&D department, using the Lynne Palmer Lynne.palmer@chsft.nhs.uk Research Passport System ext wherever possible and all current relevant guidance. Please contact R&D in the first instance. Research and Development Operational Capability Statement v1 6 City Hospitals Sunderland NHS Foundation Trust

7 Organisation R&D Interests April 2012 Information on the areas of research interest to the Organisation Organisation R&D Areas of Interest Area of Interest Cardiology Details The Cardiology team is experienced in running phase 3 & 4 studies in Cardiac Failure and ACS patients as well as stable CHD patients. Industry sponsored trials are ongoing supported by a committed R&D team. Interventional & Diagnostic facilities are available on site & a dedicated Chest Pain Assessment Unit deals with all Cardiology admissions. Contact Name Dr Shahid Junejo Contact shahid.junejo@chsft.nhs.uk Contact Number The ENT department has shown commitment to contributing to the national research agenda by recruiting to national randomised controlled trials dealing with aspects of Head & Neck Oncology treatment, as well as engaging in the application process to extend recruitment into other new trials. Alongside our colleagues in the department of Speech and ENT Language Therapy we have also developed links with Sunderland Mr James Moor James.Moor@chsft.nhs.uk University as well as other Universities across the country to recruit into non-nihr portfolio studies, again mostly involving head & neck cancer patients, as well as supporting more smallscale research activity that facilitates progression of trainee surgeons and speech therapists, both within and outwith the sphere of oncology based research. Research and Development Operational Capability Statement v1 7 City Hospitals Sunderland NHS Foundation Trust

8 The research team has specialist interests in inflammatory bowel disease, hepatology & endoscopy. We maintain close links with the North of England endoscopy Gastroenterology group and the South of Tyne GI Dr David Hobday research group to facilitate collaborative research and sign posting. We are collaborating on both national clinical trails and genetic epidemiology studies. Haematology malignancy and non-malignancy. The Department of Haematology in Sunderland Royal Hospital offers up to level 3 haematooncological therapies which includes aggressive induction and consolidation chemotherapies for high grade myeloid and lymphoid malignancies (for example acute myeloid leukaemia, lymphoblastic leukaemia, high grade lymphoma and myeloma) and also offers therapy and consultation for nonmalignant haematological disorders (for example autoimmune haemolysis, idiopathic thrombocytopaenic purpura, thrombosis and haemophilia). Our department currently participates in a large portfolio of NCRI badged studies, supports local research and is involved with industry sponsored trials. Dr Simon Lyons/Dr Scott Marshall simon.lyons@chsft.nhs.uk;scott.marshall3@nhs.net Our team of two specialist research nurses (Paula Newton and Jane Cole) work closely with the research leads Dr Scott Marshall and Dr Simon Lyons (Consultant Haematologists). Research and Development Operational Capability Statement v1 8 City Hospitals Sunderland NHS Foundation Trust

9 ICCU The Intensive Care research team has participated in a recent portfolio trial lead by ICNARC. There is close collaboration with the Newcastle University Respiratory Unit & Sunderland is a principal centre in a national portfolio trial. These close links will lead to further research into critically ill patients. The team has a specific interest in Ventilator associated pneumonia, having completed a commercially backed trial into its prevention. The results are awaiting publication. Dr Alistair Roy alistair.roy@chsft.nhs.uk The team is keen to participate in other portfolio based research, including commercially sponsored studies. Neonates The specialist team run a range of multicentre neonatal studies. There is joint collaboration with obstetric research team ensuring required follow up of infants born to mothers enrolled in studies. The team has considerable expertise in neurodevelopment outcome assessment required for many neonatal studies. Dr Lorna Gillespie lorna.gillespie@chsft.nhs.uk Obstetrics and Gynaecology Multidisciplinary research team with specialist expertise in obstetric, gynaecology & early pregnancy trials. Active recruitment to multiple NIHR portfolio trials with high accrual. Close links and active research collaboration with obstetrics/foetal medicine departments at RVI, Newcastle upon Tyne and St Thomas Hospital, London. Have worked collaboratively with Primary Care to enhance recruitment to specific NIHR trials. Mr Kim Hinshaw kim.hinshaw@chsft.nhs.uk Research and Development Operational Capability Statement v1 9 City Hospitals Sunderland NHS Foundation Trust

10 Oncology Portfolio of NIHR research is managed in collaboration with NCRN. An Acute Oncology Service (AOS) is running at City Hospitals Sunderland which covers all Oncology patients, led by the Nurse Consultant. Those entered into an oncology clinical trial are included within this. The AOS service aims to review all oncology patients admitted to Sunderland Royal Hospital. This service is available Monday to Friday & patients will be seen within 24 hours of admission to hospital (ideally day of admission) flagged via an alert system. Melanie Robertson Ophthalmology The clinical trials team has particular specialist expertise in all types of retinal disease including macular degeneration, diabetic retinopathy & vitreoretinal diseases. Onsite large cataract treatment centre with track record in large interventional clinical trials. Active recruitment to multiple NIHR portfolio trials with good track record of high recruitment and target achievement. Experience of commercial and non commercial studies. Close links with Newcastle university and growing interest in cellular and genetic therapies for retinal disease. Mr David Steel Rheumatology The rheumatology team has an interest in inflammatory arthritis studies with particular skills in MSK ultrasound. We have close links with Freeman Hospital in Newcastle. We are involved in several portfolio studies & have actively participated in industrysponsored trials. We share an interest in connective tissue disease & early rheumatoid arthritis. Dr David Coady Research and Development Operational Capability Statement v1 10 City Hospitals Sunderland NHS Foundation Trust

11 Stroke The specialist stroke team runs a 24/7 hyperacute service within a purpose-built acute stroke unit. Excellent infrastructure support from the Stroke Research Network. The team runs phase 3 and 4 clinical trials & observational studies. Excellent experience of running own multicentre acute stroke RCT as the lead centre. Dr Janice O'Connell janice.oconnell@chsft.nhs.uk Urology Research in the Urology department is primarily delivered by Prof Greene, Mr Ben Jenkins & Sue Asterling, Urology research nurse. The main ongoing projects are Biosignatures (early cancer detection using novel genetic signatures), the CROP study and SUSPEND. Other studies include the Degarelix study with future participation in LIFT (novel methods in BPH treatment) Prof Damien Greene damien.greene@chsft.nhs.uk Information on Local / National Specialty group membership within the Organisation which has been shared with the CLRN Specialty Group Membership (Local and National) National / Local Specialty Group Specialty Area (if only specific areas within group) Contact Name Contact Contact Number National Ophthalmology Mr David Steel david.steel@chsft.nhs.uk Local Age and Ageing Dr Uma Nath uma.nath@chsft.nhs.uk Local Cardiovascular Cardiology Dr Shahid Junejo shahid.junejo@chsft.nhs.uk Local Cardiovascular Vascular Mr Shanmu Vetrivel shanmu.vetrivel@chsft.nhsuk Local Gastroenterology Dr John Painter john.painter@chsft.nhs.uk Local Hepatology Dr Harriet Mitchison harriet.mitchison@chsft.nhs.uk Local Metabolic and Endocrine Dr John Chapman john.chapman@chsft.nhs.uk Local Musculoskeletal Disorders Dr David Coady david.coady@chsft.nhs.uk Local Nervous System Disorders Dr Peter Cleland peter.cleland@chsft.nhs.uk Local Paediatrics Dr Lorna Gillespie lorna.gillespie@chsft.nhs.uk Local Renal Dr Saeed Ahmed saeed.ahmed@chsft.nhs.uk Local Reproductive Health & Childbirth Mr Kim Hinshaw kim.hinshaw@chsft.nhs.uk Local Respiratory Dr Ian Taylor ian.taylor@chsft.nhs.uk Local Surgery/Urology Prof Damien Greene damien.greene@chsft.nhs.uk Research and Development Operational Capability Statement v1 11 City Hospitals Sunderland NHS Foundation Trust

12 Organisation R&D Planning and Investments April 2012 Planned Investment Area of Investment (e.g. Facilities, Training, Recruitment, Equipment etc.) Further recruitment of generic nurse/cto staff to enhance trial recrutiment is planned for 2012 Description of Planned Investment Two full-time posts are being actively recruited (June 2012) Value of Investment Particular focus for one post will be to support setup and accrual to industry sponsored trials Indicative dates Aug-12 Organisation R&D Standard Operating Procedures Register Standard Operating Procedures SOP Ref Number SOP Title SOP Details Valid from Valid to Trust Standard Operating Procedures are held on the Trust Intranet. Ongoing review Information on the processes used for managing Research Passports Indicate what processes are used for managing Research Passports These are issued and managed by the Department of R&D in collaboration with HR in accordance with current guidance. Joint spreadsheet is maintained. Information on the agreed Escalation Process to be used when R&D governance issues cannot be resolved through normal processes Escalation Process From R&D Administrator, to R&D Manager, then R&D Director followed by the Medical Director and/or Chief Executive. Planned and Actual Studies Register The Organisation should maintain or have access to a current list of planned and actual studies which its staff lead or collaborate in. Comments The R&D Department maintains a database with details of all planned and actual studies. Please contact the R&D Manager for information. Other Information For example, where can information be found about the publications and other outcomes of research which key staff led or collaborated in? Other Information (relevant to the capability of the Organisation) The R&D team has worked to increase the number of specialties recruiting into NIHR portfolio trials over the last 3 years. Accrual to all studies has increased year on year with a 90% increase in total accrual from 2011 to (2010= 563 [4% total CLRN accrual] ; 2011= 722 [5% of total CLRN accrual] ; 2012= 1395 [9% of total CLRN accrual]. The focus for 2012 is to achieve a further increase in overall accrual with a CLRN target set of There is a commitment to increase active participation in NIHR portfolio industry-sponsored research. The Department has developed a formal vision and is working collaboratively with external bodies to develop formal partnerships (this includes collaborative work with the University of Sunderland, where there is a very active pharmacy research programme, liaising with several major pharmaceutical firms). Please contact the R&D Manager directly if you require any further specific information. Research and Development Operational Capability Statement v1 12 City Hospitals Sunderland NHS Foundation Trust