Working together for better Research - Collaborative research with BCUHB Dr Nefyn Williams & Dr Richard Tranter, NWORTH Associate Clinical Directors & BCUHB R&D Assistant Directors Key North Wales health research stakeholders North Wales AHSC Hub NISCHR CRC Bangor University BCUHB Glyndwr University, Welsh Ambulance Service, Powys LHB Jointly supporting the development of health researchers NWRC small grants scheme BCUHB academic support programme Early career researcher CPG academic boards NISCHR fellowship National funding and NISCHR portfolio project Established Bangor University research teams Developing health research infrastructure in North Wales • NISCHR activity based funding of R&D: Increase in BCUHB allocation to £1.3 million for 2012. • Research support post competition 2011: new posts in pharmacy and radiology to support clinical research. • Methodology support post competition 2012: NWORTH coordinated bid for new IT and health economics posts in Bangor University to support AHSC hub. • R&D offices, finance, administration, health records, KESS & KTP scholarships. Developing a health research quality system for North Wales • Collaboration between BCUHB, Bangor University and NISCHR CRC. • BCUHB MHRA inspection 2012. • Bangor University CoHABS research governance review. • Jointly develop health research SOPs and approval/review process. • Jointly develop training programmes for researchers. • Jointly develop sponsorship, monitoring and audit systems. Welcome to the research roadmap. This site has been developed jointly by BCUHB, Bangor University and NISCHR CRC to help guide clinicians and academics through the processes needed to conduct safe and high quality health research. The road map arranges all the current Standard Operating Procedures (SOPs) relating to health research in use in BCUHB and Bangor University according to the stage of the research project, and the role of the individual within the research project. Project stages: Planning a project Applying for permissions Site setup Conducting research Site closure Reporting results Research roles: Students Research support staff (eg RAs, CSOs) Principal and Chief Investigators Sponsors Every researcher must be familiar with the SOPs relevant to their role in the project. Each stage on the roadmap is linked to a training module relevant to your research role. You can register on this site using your BCUHB or BU username and password (click here) so that completion of training modules can be logged. It is expected that you will complete the training module before you embark on that stage of your project. Compliance with training will be monitored. This site is the only source for the up to date version of a research SOP. If you print an SOP from this site it will be time stamped and will be valid only for that day. Go to roadmap Role Student Research support staff PI or CI sponsor 1. Planning & Preparation 1 1 1 1 2. Permissions & registration 2 2 2 2 3. Setup & activation 3 3 3 3 4. Running a study 4 4 4 4 5. Closing and follow-up 5 5 5 5 Stage Organisation Quality System Managing approvals Oversight 6. Reporting & dissemination 6 6 6 6 Applying for permissions Making an IRAS application: Register with university school and internal peer review Study approvals SOP 4.01 Link to IRAS site Link to IRAS guidance Trial Master File SOP 3.04, DM2 Report deviations from SOPs You may require specific permissions depending on your project: IRMER SOP** Does your study require clinical trial authorisation from the MHRA? Study approvals SOP 4.01, QA4 Link to MHRA algorithm ?human tissue act, children, incapacitated adults: add as website guidance Clinical Trial Authorisation SOP 4.02 All clinical trials should be registered on an appropriate public database prior to start date: Clinical trial registration checklist Link to list of public clinical trial registers NISCHR portfolio/RDG registration Go to MCQ What clinical trial agreements do you need in place? Consider agreements with local departments and external collaborators and sponsors: Clinical trial agreements SOP 4.04 Do any team members need permission to work in the Health Board or with GPs? Honorary contracts SOP** Letters of access SOP D2 Go to roadmap SOPs for CIs setting up a research site Trial Master File SOP 3.04, DM2 Document control SOP DM2 CRF design and control SOP D1 Management of study specific SOPs SOP** Data management SOP 6.01 IT systems in research SOP6.02 Defining responsibilities SOP RS2 Delegation log SOP RS2 Staff training & training records SOP T1, T2, 2.01 Risk assessment for research SOP** Monitoring ( including independent data monitoring and steering committee ) SOP 3.07, M1 Report deviations from SOPs • How to manage all the essential documents for your study • IT and data management systems • Defining responsibilities and training of research staff • Doing a risk assessment and planning monitoring for your study Go to MCQ Go to roadmap IT link posts • 2 posts one based in NWORTH the other in BCUHB • Contribute to the planning of IT infrastructure to facilitate the integration of research studies into routine clinical practice • Design, develop & implement IT systems, services & applications for use in research studies Clinical Rehabilitation Facility • Possible future development between BU & BCUHB • Clinical rehabilitation is a strong & developing theme of research • Builds on strengths – – – – – – Exercise science & sports medicine Lifestyle and behaviour change Mental health and dementia care Applied health & social care Trials, economics, knowledge translation Chronic disease management in primary & secondary care • Cardiovascular, respiratory, renal, diabetes, musculoskeletal, cancer, older people, children & disability, stroke, dementia summary • Putting the “U” into BCUHB: public statement on the role of teaching and research in the Health Board. • Jointly supporting the development of new health researchers with clear long term goals. • Jointly supporting established research teams and collaborations for large scale bids and increased portfolio studies. • Jointly creating a health research quality system.