Presentation on theme: "Working together for better Research - Collaborative research with BCUHB Dr Nefyn Williams & Dr Richard Tranter, NWORTH Associate Clinical Directors &"— Presentation transcript:
1Working together for better Research - Collaborative research with BCUHB Dr Nefyn Williams & Dr Richard Tranter, NWORTH Associate Clinical Directors & BCUHB R&D Assistant Directors
2Key North Wales health research stakeholders North Wales AHSC HubNISCHR CRCBangor UniversityBCUHBGlyndwr University, Welsh Ambulance Service, Powys LHB
3Jointly supporting the development of health researchers NWRC small grants schemeBCUHB academic support programmeEarly career researcherCPG academic boardsEstablished Bangor University research teamsNISCHR fellowshipNational funding and NISCHR portfolio project
4Developing 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.
5Developing 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.
6Welcome to the research roadmap 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 Research roles: StudentsApplying for permissions Research support staff (eg RAs, CSOs)Site setup Principal and Chief InvestigatorsConducting research SponsorsSite closureReporting resultsEvery 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.Go to roadmapThis 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.
7Research support staff RoleResearch support staffStudentPI or CIsponsorOrganisationStagePlanning & Preparation1.1111QualitySystemPermissions & registration2.2222Setup & activation3.3333ManagingapprovalsRunning a study4.4444Closing and follow-up5.5555OversightReporting & dissemination6.6666
8Applying for permissions Register with university school and internal peer reviewTrial Master File SOP 3.04, DM2Link to IRAS guidanceLink to IRAS siteStudy approvals SOP 4.01Making an IRAS application:?human tissue act, children, incapacitated adults: add as website guidanceStudy approvals SOP 4.01, QA4IRMER SOP**You may require specific permissions depending on your project:Clinical Trial Authorisation SOP 4.02Link to MHRA algorithmDoes your study require clinical trial authorisation from the MHRA?NISCHR portfolio/RDG registrationLink to list of public clinical trial registersClinical trial registration checklistAll clinical trials should be registered on an appropriate public database prior to start date:Clinical trial agreements SOP 4.04What clinical trial agreements do you need in place? Consider agreements with local departments and external collaborators and sponsors:Letters of access SOP D2Honorary contracts SOP**Do any team members need permission to work in the Health Board or with GPs?Go to roadmapReport deviations from SOPsGo to MCQ
9SOPs for CIs setting up a research site Management of study specific SOPs SOP**CRF design and control SOP D1Document control SOP DM2Trial Master File SOP 3.04, DM2How to manage all the essential documents for your studyIT systems in research SOP6.02Data management SOP 6.01IT and data management systemsStaff training & training records SOP T1, T2, 2.01Delegation log SOP RS2Defining responsibilities SOP RS2Defining responsibilities and training of research staffMonitoring ( including independent data monitoring and steering committee ) SOP 3.07, M1Risk assessment for research SOP**Doing a risk assessment and planning monitoring for your studyReport deviations from SOPsGo to MCQGo to roadmap
10IT 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 practiceDesign, develop & implement IT systems, services & applications for use in research studies
11Clinical Rehabilitation Facility Possible future development between BU & BCUHBClinical rehabilitation is a strong & developing theme of researchBuilds on strengthsExercise science & sports medicineLifestyle and behaviour changeMental health and dementia careApplied health & social careTrials, economics, knowledge translationChronic disease management in primary & secondary careCardiovascular, respiratory, renal, diabetes, musculoskeletal, cancer, older people, children & disability, stroke, dementia
12summaryPutting 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.