Presentation on theme: "Working together for better Research - Collaborative research with BCUHB Dr Nefyn Williams & Dr Richard Tranter, NWORTH Associate Clinical Directors &"— Presentation transcript:
Working together for better Research - Collaborative research with BCUHB Dr Nefyn Williams & Dr Richard Tranter, NWORTH Associate Clinical Directors & BCUHB R&D Assistant Directors
North Wales AHSC Hub Glyndwr University, Welsh Ambulance Service, Powys LHB NISCHR CRC Bangor University BCUHB Key North Wales health research stakeholders
Early career researcher NWRC small grants scheme BCUHB academic support programme CPG academic boards Established Bangor University research teams NISCHR fellowship National funding and NISCHR portfolio project Jointly supporting the development of health researchers
Developing health research infrastructure in North Wales NISCHR activity based funding of R&D: Increase in BCUHB allocation to £1.3 million for 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 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 projectResearch roles:Students Applying for permissionsResearch support staff (eg RAs, CSOs) Site setupPrincipal and Chief Investigators Conducting researchSponsors Site closure Reporting results 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 roadmaproadmap
Planning & Preparation Permissions & registration Setup & activation Running a study Reporting & dissemination Closing and follow-up Student Research support staff PI or CI Role Stage sponsor Quality System Managing approvals Oversight Organisation
Applying for permissions Register with university school and internal peer review Making an IRAS application: Study approvals SOP 4.01 Link to IRAS site Link to IRAS guidance Trial Master File SOP 3.04, DM2 You may require specific permissions depending on your project: IRMER SOP** Study approvals SOP 4.01, QA4 ?human tissue act, children, incapacitated adults: add as website guidance Does your study require clinical trial authorisation from the MHRA? Link to MHRA algorithm 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 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 roadmaproadmap Go to MCQ Report deviations from SOPs
SOPs for CIs setting up a research site How to manage all the essential documents for your study Trial Master File SOP 3.04, DM2 Document control SOP DM2 CRF design and control SOP D1 Management of study specific SOPs SOP** IT and data management systems Data management SOP 6.01 IT systems in research SOP6.02 Defining responsibilities and training of research staff Defining responsibilities SOP RS2 Delegation log SOP RS2 Staff training & training records SOP T1, T2, 2.01 Doing a risk assessment and planning monitoring for your study Risk assessment for research SOP** Monitoring ( including independent data monitoring and steering committee ) SOP 3.07, M1 Go to roadmaproadmap Go to MCQ Report deviations from SOPs
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.