Secretary: Mathew Gane email@example.com
Terms of Reference
The remit of the University of Warwick Sponsorship and Oversight Committee (the Committee) is to ensure that staff and student studies sponsored by the University of Warwick (the University) comply with the requirements of the UK Policy Framework for Health and Social Care Research (2017) and/or the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and to standards of Good Clinical Practice (GCP).
The Committee also manages any reputational risk to the University that may arise as a result of the University acting as sponsor of research carried out within the NHS or social care and also for clinical trials conducted outside the UK.
The Committee will review all staff and student applications for University sponsorship or co-sponsorship for studies that require sponsorship under the UK Policy Framework for Health and Social Care Research (2017). The Committee will also review applications for clinical trials carried out outside the UK, and provide appropriate sponsor oversight of sponsored studies on behalf of the University, ensuring compliance with sponsor responsibilities and other applicable legislative requirements.
Specifically the Committee will:
a) Receive and review sponsorship applications from University staff and students, and approve, conditionally approve, or reject applications;
b) Receive and review sponsorship applications for clinical trials carried out outside the UK.
c) Receive, and have oversight of, reports submitted by Warwick Clinical Trials Unit (WCTU) in relation to University of Warwick sponsored or co-sponsored WCTU managed studies;
d) Receive, and have oversight of, reports submitted by the Sponsor’s Office detailing the low risk non-interventional studies approved via delegated procedures;
e) Ensure that studies sponsored or co-sponsored by the University can be undertaken within the requirements of the UK Policy Framework for Health and Social Care Research (2017), the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and to standards of Good Clinical Practice;
f) Provide oversight of the management of University of Warwick Sponsored studies;
g) Ensure that the projected financial plans for studies provide the necessary funding with which to deliver the study and are in line with the current costing attribution of the Department of Health;
h) Ensure that studies have the necessary insurance cover from the outset;
i) Ensure that studies receive appropriate peer review; and
j) Ensure that a robust risk-assessment is carried out in order to inform the Committees decision on whether to issue Sponsorship approval.
In reviewing applications, the Committee will have due regard for:
a) Compliance with the UK Policy Framework for Health and Social Care Research (2017), the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and to standards of Good Clinical Practice, as applicable;
b) Compliance with the University’s Sponsorship & Oversight Policy;
c) The allocation of trial/study monitors, appropriate to the needs of the trial/study, and for international trials/studies, the availability of an International Trial Monitor to provide reasonable oversight;
d) The allocation of staff resource and facilities required to deliver the study;
e) Evidence of appropriate peer review of the scientific design and quality of the study;
f) Evidence that the finances attached to the study are adequate to allow the University to discharge its sponsor responsibilities; and
g) The results of the risk assessment any subsequent agreed actions for monitoring, managing or mitigating risk.
h) The Committee will receive the following regular reports:
- Progress against Quality Assurance Audit Plans for University sponsored studies and WCTU managed studies
- Quality Assurance Audit and Monitoring reports completed since the last meeting
- Annual and End of Study REC reports submitted since the last meeting
- Development Safety Update Report (DSUR) reports submitted since the last meeting
- Protocol and/or GCP violations/serious breaches, with any Medicines and Healthcare products Regulatory Agency (MHRA) reported serious breaches also being referred immediately to the Chair of the Committee.
- Suspected Unexpected Serious Adverse Reaction (SUSAR) line reporting, with immediate referral to the Chair of the Committee.
- Report on any SOPs that have exceeded their next review date
- Minutes of the WCTU Governance Committee
- Sponsor’s Office report of low-risk non-interventional studies approved via delegated procedures
- Report on WCTU managed studies, including those:
- Open and recruiting
- In follow-up
- In set up
- Grants submitted and pending decision
- Grants in work up
i) The Committee will also receive the following annual reports:
- Quality Assurance Audit Plan for WCTU managed studies
- Quality Assurance Audit Reports for external clinical trials units that manage a University sponsored study
The quorum for the Committee will be five members, including the Chair, a representative of Research & Impact Services, and a representative of the University’s Clinical Trials Unit.
The Committee reports to the University Research Governance and Ethics Committee.
Membership (Ex Officio)
|Chair||Professor Anne-Marie Slowther|
|Research Governance & Quality Assurance Manager||Mathew Gane (Secretary)|
|Assistant Director of R&IS & Head of Research Governance||Carole Harris|
|Director of Warwick Clinical Trials Unit (WCTU)||Professor Gavin Perkins|
|Head of Operations, WCTU||Natalie Strickland|
|Head of Research Development & Innovation, University Hospitals Coventry &
Warwickshire (UHCW) (or nominated representative)
|Chief Operating Officer Warwick Medical School (WMS)||Jane Hodge|
|Chair of the University’s Biomedical and Scientific Research Ethics Committee||
Dr David Ellard
|Human Tissue Designated Individual (DI)||
Professor John Davey
|Head of Governance & Quality, WMS||Neil Stockton|
|Research Support Manager, WMS (R&IS)||Debbie Owen|
Insurance Services Manager (Finance Office)
|Information & Data Director/ Warwick Group Data Protection Officer (or nominated representative)||TBC|
|Nominated clinical and academic representatives||
Professor Janet Dunn
Professor James Mason (Deputy Chair)
Professor Ponnusamy Saravanan
Professor Debra Bick
Dr Maja Korica
In attendance (Ex Officio)
|Research Governance & Quality Assurance Manager, R&IS||Mathew Gane|
|Quality Assurance Manager, WCTU (or nominated WCTU QA Team representative)||Claire Daffern|
|Research Governance & Quality Assurance Manager, R&IS||Dr Rosie Bellamy|
|Research Support Officer (Governance & Ethics), R&IS||Dale Topley|