Working together for better Research

Report
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.

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