The sponsor is responsible for ensuring that arrangements are in place for the research team to access resources and support, to deliver the research as proposed and ensure that agreements are in place which specify responsibilities for the management and monitoring of research. They are also responsible for identifying and addressing poorly designed or planned research and poor quality research proposals, protocols or applications, as well as ensuring that proposals are scientifically sound.

Sponsors must also ensure that arrangements are in place to review significant developments as the research proceeds, particularly those that put the safety of individuals at risk, and to approve modifications to the study design. The UK Policy Framework for Health and Social Care Research (2017)Link opens in a new window requires that the sponsor be confirmed prior to the commencement of a study.

Clinical trials of Investigational Medicinal Product/s (CTIMPs) are governed by the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). These require that all CTIMPs must declare an agreed sponsor to the Competent Authority prior to the commencement of the trial. The Competent Authority in the UK is the Medicines and Healthcare Products Regulatory Agency (MHRA).

The University does not allow individuals to sponsor trials, and any University employee or student that wishes to deliver a study within the NHS or social care must apply to the University for sole or co-sponsorship.

Once you have established that University research sponsorship will be required for your project, you will need to apply for and receive full approval from the Sponsorship & Oversight Committee, in addition to HRA and NHS REC or other REC approval (as applicable) before beginning your study. For studies requiring an application for HRA/ NHS REC approval via IRAS, Sponsorship & Oversight Committee approval will be required prior to an application being submitted via IRAS.

Approvals cannot be granted retrospectively, so it is important to consider approval timescales when planning your project.

Applications for sponsorship must be made by a substantive member of University staff, or a registered student in conjunction with their University employed supervisor, who will be expected to act as the Chief Investigator.

In certain cases, the University’s decision to sponsor a study classified as an interventional clinical trial shall be dependent on the study being ran through a UK-CRC registered Clinical Trials Unit.

All applications for University sole or co-sponsorship should be made on the sponsorship application form, available hereLink opens in a new window.

The completed form should be submitted to the Research Governance Team via email to sponsorship@warwick.ac.uk, along with the documentation listed in the ‘Chief Investigator Declaration’ section of the Sponsorship Application Form, including all participant facing documentation and recruitment materials.

The Sponsorship & Oversight Committee reviews all applications for research sponsorship. Sponsorship applications must be received by the Sponsor's Office in R&IS via sponsorship@warwick.ac.uk 4 weeks ahead of the meeting date, to be considered by the Committee at that meeting.

Applicants will be notified of the sponsorship decision within ten working days of the Committee meeting.

Once received, your application will be risk assessed by the Sponsor's Office.

Applications assessed as moderate - high risk or interventional in nature will be subject to review at a full Sponsorship & Oversight Committee meeting. Meeting dates and deadlines for the receipt of full Sponsorship & Oversight Committee applications are shown below.

Deadline for Applications	Full Committee Meeting Date
Friday 16 February 2024	Friday 15 March 2024
Friday 19 April 2024	Friday 17 May 2024
Friday 21 June 2024	Friday 19 July 2024

Applications assessed to be low risk and non-interventional in nature will be suitable for review by the Sponsor's Office. Meeting dates and deadlines for the receipt of such applications are shown below.

Deadline for Applications	Sponsor's Office Meeting Date
Tuesday 20 February 2024	Tuesday 19 March 2024
Tuesday 19 March 2024	Tuesday 16 April 2024
Tuesday 16 April 2024	Tuesday 14 May 2024
Tuesday 28 May 2024	Tuesday 25 June 2024
Tuesday 18 June 2024	Tuesday 16 July 2024

What is HRA approval?

IRAS Application Form

Applying to the HRA

Organisational Information Document & Schedule of Events

Research Sponsorship

Arranging review of HRA applications

After submission

UK Clinical Research Network Portfolio Eligibility & Support

Research Passports, honorary contracts and gaining NHS R&D Trust Permissions

Student Research

Training

As a condition of University sponsorship, researchers working on Warwick sponsored studies are required to comply with all relevant requirements of our Standard Operating Procedures (SOPs), which are applicable to all University of Warwick sponsored studies and are available here. Please note that these SOPs apply to all Warwick sponsored studies and are not limited to clinical trials.

In particular, researchers working on University sponsored studies should also ensure they understand the relevant safety and compliance reporting requirements applicable to their study, as set out in SOP 17 ‘Safety Reporting’ and SOP 31 ‘Deviations, Violations, Misconduct and Serious Breaches of GCP and/or Trial Protocol’. If advice or guidance is required, please contact the Sponsor’s Office via sponsorship@warwick.ac.uk.

More generally, all researchers involved in Warwick research studies are required at all times to comply with the University’s Research Code of Practice.

Online Research Integrity Training

It is mandatory for all staff involved in the delivery of research to complete the concise version (45 minutes) of the online research integrity training. Research students are advised to complete the full version.

All staff and students applying for sponsorship approval must also complete the supplementary ‘Protecting Human Participants’ module (15 minutes).

The online research integrity training can be accessed here.

Good Clinical Practice (GCP) Training

Good Clinical Practice (GCP) training is required to be undertaken by all Chief Investigators of University of Warwick sponsored studies. An online e-learning course is available via the National Institute for Health Research here. Alternatively, a face-to-face course may be available through Warwick Clinical Trials Unit, further details can be obtained by contacting wctuqa@warwick.ac.uk

Chief Investigator Training

Warwick Clinical Trials Unit also offers a training course for Chief Investigators. This is a full two-day event which will run twice a year. It is recommended for anyone acting as CI for a clinical trial sponsored by the University of Warwick. The day combines presentations and interactive sessions to cover all aspects of trial management from initial planning right through to closing a trial.

Please contact wctuqa@warwick.ac.uk for more information.

Human Tissue Training

All staff and students undertaking research involving human tissue must be able to demonstrate their competency and be registered to do so. They must register as working with human tissue with the Human Tissue Act Designated Individual (DI), be familiar with the relevant documentation and SOPs, undergo training and maintain a training portfolio.

Please see the Use of Human Tissue at Warwickwebpages or contact HTA@warwick.ac.uk for more information.

Other training for researchers

The University takes its responsibilities for training seriously as part of its commitment to the Concordat to Support Research IntegrityLink opens in a new windowLink opens in a new window and the Concordat to Support the Career Development of ResearchersLink opens in a new windowLink opens in a new window.

Please see the Leadership and Management Development pages to find out more about the range of training and individual support available to researchers.

Changes to a study over the course of its conduct are considered amendments. These could, for example, be changes to protocol procedures, participant-facing documents, key study staff, data collection or analysis, dissemination and publication arrangements, or the addition or removal of sites conducting the study.

All amendments to The University of Warwick sponsored or co-sponsored studies must be submitted to the Sponsor’s Office for review and authorisation, prior to submission to the HRA and the approving Research Ethics Committee. The Sponsor’s Office is responsible for determining the substantiality (classification) of amendments and formally authorising the completed amendment tool.

Detailed guidance on how to complete and submit amendments is available hereLink opens in a new window.

Annual and end of study reporting is the responsibility of the Chief Investigator of University of Warwick sponsored or co-sponsored studies.

All NHS REC approved studies are required to submit an Annual Progress Report to the approving REC each year after approval is granted. Further details are available on the HRA webpages.Link opens in a new window For University sponsored or co-sponsored studies, the Sponsor’s Office should be copied into the submission of Annual Progress Reports to the REC via sponsorship@warwick.ac.uk.

For studies with University or non-NHS REC ethical approval, an Annual Report to Sponsor Form, available hereLink opens in a new window, should be completed and submitted to the this to the Sponsor’s Office via sponsorship@warwick.ac.uk within one month of the anniversary of the University sponsorship approval.

At the end of the study, for NHS REC/ HRA approved studies, an End of Study DeclarationLink opens in a new window must be submitted to the approving REC/ HRA. Notification to other review bodies may also be required depending on the nature of the study. Further details can be found on the HRA webpages here. The Sponsor’s Office should be copied into the submission of the report via sponsorship@warwick.ac.uk.

For studies with University or non-NHS REC ethical approval, the Sponsor’s Office should be notified in writing via sponsorship@warwick.ac.uk when the study has ended, however there is no prescribed format for this notification.

Secretary: Mathew Gane m.gane@warwick.ac.uk

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 of the UK

c) Receive, and have oversight of reports submitted by Warwick Clinical Trials Unit (WCTU) in relation to The 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 The 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

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

g) The results of the risk assessment any subsequent agreed actions for monitoring, managing or mitigating risk

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

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 James Mason
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) (or nominated representative)	Professor Nigel Stallard
Head of Operations, WCTU	Natalie Strickland
Head of Research Development & Innovation, University Hospitals Coventry & Warwickshire (UHCW) (or nominated representative)	Ceri Jones
Chief Operating Officer Warwick Medical School (WMS)	Jane Hodge
Chair of the University’s Biomedical and Scientific Research Ethics Committee	Professor David Ellard
Human Tissue Designated Individual (DI)	Professor Geraldine Hartshorne
Head of Governance & Quality, WMS	TBC
Research Support Manager, WMS (R&IS)	Debbie Owen
Insurance Services Manager (Finance Office)	Richard Campbell-Kelly
Nominated clinical and academic representatives	Professor Janet Dunn TBC (Deputy Chair) Professor Ponnusamy Saravanan Professor Debra Bick Dr Jo Parsons

 

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	Alex Killey