1. Working together for better Research - Collaborative research with BCUHB
Dr Nefyn Williams & Dr Richard Tranter, NWORTH Associate Clinical Directors & BCUHB R&D Assistant Directors

2. Key North Wales health research stakeholders
North Wales AHSC Hub
NISCHR CRC
Bangor University
BCUHB
Glyndwr University, Welsh Ambulance Service, Powys LHB

3. Jointly supporting the development of health researchers
NWRC small grants scheme
BCUHB academic support programme
Early career researcher
CPG academic boards
Established Bangor University research teams
NISCHR fellowship
National funding and NISCHR portfolio project

4. 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.

5. 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.

6. Welcome 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: Students
Applying for permissions Research support staff (eg RAs, CSOs)
Site setup Principal and Chief Investigators
Conducting research Sponsors
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.
Go to roadmap
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.

7. Research support staff
Role
Research support staff
Student
PI or CI
sponsor
Organisation
Stage
Planning & Preparation 1. 1 1 1 1
Quality
System
Permissions & registration 2. 2 2 2 2
Setup & activation 3. 3 3 3 3
Managing
approvals
Running a study 4. 4 4 4 4
Closing and follow-up 5. 5 5 5 5
Oversight
Reporting & dissemination 6. 6 6 6 6

8. Applying for permissions
Register with university school and internal peer review
Trial Master File SOP 3.04, DM2
Link to IRAS guidance
Link to IRAS site
Study approvals SOP 4.01
Making an IRAS application:
?human tissue act, children, incapacitated adults: add as website guidance
Study approvals SOP 4.01, QA4
IRMER SOP**
You may require specific permissions depending on your project:
Clinical Trial Authorisation SOP 4.02
Link to MHRA algorithm
Does your study require clinical trial authorisation from the MHRA?
NISCHR portfolio/RDG registration
Link to list of public clinical trial registers
Clinical trial registration checklist
All clinical trials should be registered on an appropriate public database prior to start date:
Clinical trial agreements SOP 4.04
What clinical trial agreements do you need in place? Consider agreements with local departments and external collaborators and sponsors:
Letters of access SOP D2
Honorary contracts SOP**
Do any team members need permission to work in the Health Board or with GPs?
Go to roadmap
Report deviations from SOPs
Go to MCQ

9. SOPs for CIs setting up a research site
Management of study specific SOPs SOP**
CRF design and control SOP D1
Document control SOP DM2
Trial Master File SOP 3.04, DM2
How to manage all the essential documents for your study
IT systems in research SOP6.02
Data management SOP 6.01
IT and data management systems
Staff training & training records SOP T1, T2, 2.01
Delegation log SOP RS2
Defining responsibilities SOP RS2
Defining responsibilities and training of research staff
Monitoring ( including independent data monitoring and steering committee ) SOP 3.07, M1
Risk assessment for research SOP**
Doing a risk assessment and planning monitoring for your study
Report deviations from SOPs
Go to MCQ
Go to roadmap

10. 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

11. 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

12. 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.