Secretary: Mathew Gane firstname.lastname@example.org
Terms of Reference
The remit of the University of Warwick Sponsorship Committee (the Committee) is to ensure that studies sponsored by the University of Warwick (University) receive appropriate peer review, and comply with the requirements of the Research Governance Framework for Health and Social Care (2005), and/or the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and to standards of Good Clinical Practice (GCP).
The Committee will review all applications for University sponsorship or co-sponsorship for all studies that require sponsorship under the Research Governance Framework (2005), and will provide appropriate sponsor oversight for sponsored studies, ensuring compliance with sponsor responsibilities and all other requirements of the Research Governance Framework (2005) and additionally, with the Medicines for Human Use (Clinical Trials) Regulations 2004 for all Clinical Trials of Investigational Medicinal Products (CTIMPs).
Specifically the Committee will:
a) Receive and review sponsorship applications from University staff and students, and approve, or approve in principle, and/or reject said applications;
b) Ensure that studies sponsored or co-sponsored by the University can be undertaken within the requirements of the Research Governance Framework for Health and Social Care (2005), the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and to standards of Good Clinical Practice;
c) Receive and review on behalf of the University applications from University staff and students to deliver clinical trials outside of the EU and to approve, or approve in principle and/or reject said applications on behalf of the University;
d) Ensure that the projected financial plan for the study provides the necessary funding with which to deliver the study and is in line with the current costing attribution of the Department of Health; and
e) Ensure that the study has the necessary insurance cover from the outset.
In reviewing applications, the Committee will have due regard for:
f) Compliance with the Research Governance Framework for Health and Social Care (2005), the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and to standards of Good Clinical Practice, where appropriate;
g) Compliance with the University’s sponsorship policies for the sponsorship and/or co-sponsorship of CTIMPs and non-CTIMPS;
h) The availability of trial monitors, appropriate to the needs of the trial, and for international trials, the availability of an International Trial Monitor to provide reasonable oversight;
i) The availability of staff and facilities required to deliver the research;
j) Evidence of appropriate peer review of the scientific design and quality of the study;
k) Evidence that the finances attached to the study are adequate to allow the University to discharge its sponsor responsibilities; and
l) The risks that can reasonably be said to emanate from the application, ensuring that a robust risk assessment and action plan for monitoring, managing or mitigating risk has been developed.
The Committee will also receive, for all CTIMPs and interventional trials, a series of regular reports to ensure appropriate oversight during their lifecycle, as follows:
- Report on any risks identified since the last meeting of the Committee
- Protocol and/or GCP violations/serious breaches
- SUSAR line reporting, with any MHRA reported SUSARs also being referred immediately to the Chair of the Committee.
- Report of DSUR submissions against due dates
- Compliance of monitoring visits against plan
- Report of international sites on CTIMPs
- Trial Steering Committee recommendations to sponsor
- Quality Assurance Audit Reports of CTUs.This will apply to all CTUs that are managing a University-sponsored or co-sponsored study
- Compliance with University policies and SOPs including notification of the end of the study and a summary of results.
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 will report to the University Research Governance and Ethics Committee.
Membership (Ex Officio)
|Chair of Faculty of Medicine||Professor Aileen Clarke (Chair)|
|Research Governance & Quality Assurance Manager||Mr. Mathew Gane (Secretary)|
|Chair of the University’s Biomedical and Scientific Research Ethics Committee||TBC|
|Chief Operating Officer Warwick Medical School (WMS)||Ms. Jane Hodge|
|Head of Governance & Quality, WMS||Mr. Neil Stockton|
|Director of Research & Impact Services (R&IS)||Dr. Catherine Cochrane|
|Deputy Director of R&IS & Head of Research Governance||Mrs. Jane Prewett|
|Research Support Manager, WMS (R&IS)||Ms. Debbie Greer|
|Deputy Director of Warwick Clinical Trials Unit||Professor Janet Dunn|
Head of Research Development & Innovation,
|Ms. Ceri Jones|
|Three nominated clinical and academic representatives||
Dr. Xavier Armoiry
Professor David Fitzmaurice
|Insurance Services Manager (Finance Office)||Mr. Richard Campbell-Kelly|
|One Nominated representative from Institutional Governance||TBC|
|Warwick Clinical Trials Unit Manager||Ms. Natalie Strickland|
In attendance (Ex Officio)
|Quality Assurance Manager, Warwick Clinical Trials Unit||Ms. Claire Daffern|
|Research Support Officer (Governance & Ethics),
Research & Impact Services
|Ms. Emily Dight|