Terms of Reference

Background

The Clinical Trials Sponsorship Committee was originally established to consider the University’s conduct of clinical trials in scope with the Medicines for Human Use (Clinical Trials) Regulations 2004, when acting either as a sponsor or co-sponsor of such trials. The University has also conducted equivalent international trials outside of the EU regulatory framework. The terms of reference of the Committee is now extended (as of March 2022) to consider review of other clinical trials where similar risk of harm to participants or a statutory
risk to the University may present.

Terms of Reference

1. The Committee shall take responsibility for procedure relating to the performance of all interventional clinical trials, either sponsored or co-sponsored (as defined in the UK Policy Framework for Health and Social Care Research, v3.3, November 2017) by the University in accordance with the Policy for Clinical Research[1], where there is a significant risk of physical or psychological harm to participants of the research or a statutory risk to the University. A clinical trial shall mean a study where participants receive a diagnostic, therapeutic, or other type of intervention determined by the study's protocol to evaluate the effectiveness or safety of the intervention in relation to a clinical outcome, or an assessment of non-clinical or purely physiological or other parameter associated with the intervention, and may include, but not limited to, investigation of medicinal products or medical devices, regardless of whether the study is conducted in accordance with a statutory requirement or out of scope of a statutory requirement or an exemption applies. The remit of the Committee includes all clinical trials (highlighted in yellow in section A of Appendix 1) where the focus of the investigation is either a medicinal product (or other substances) or certain categories of medical device or otherwise where the intervention is invasive (delivered through an opening in the skin or other transdermal means of delivery or into a body cavity) or deemed to be burdensome taking into account the nature of the procedures and the vulnerability of the clinical trial subjects (subject to an assessment of risk conducted with the research team).
2. The Committee shall take responsibility for the development of policies and procedures (including standard operating procedures) to ensure compliance with legal requirements and international standards for the conduct of interventional clinical trials, including, but not limited to;
   1. defining the essential requirements in order for the University to sponsor or co-sponsor (with another organisation) clinical trials meeting the criteria set out in (1);
   2. defining appropriate standards for the conduct of clinical trials meeting the criteria set out in (1), including procedures to ensure sponsor oversight;
   3. monitoring and ensuring compliance of registering clinical trial protocols and reporting of results of all clinical trials (including, but not limited to clinical trials meeting the criteria set out in (1)) in accordance with statutory requirements, a condition of a favourable ethical opinion or applicable codes of practice;
   4. recommending revisions to the University’s Policy for Clinical Research to the University Research Committee;
3. The Committee shall take overall responsibility for ensuring that the University fulfils its legal duties as a sponsor or co-sponsor, including the decision to sponsor or co- sponsor a clinical trial of an Investigational Medical Product in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 or sponsor a Clinical Investigation of a Medical Device conducted in accordance with the Medical Devices Regulations (2002) or the equivalents conducted outside the UK.
4. The Committee shall conduct a formal review of the arrangements for the conduct of clinical trials meeting the criteria set out in (1) prior to the start of the study and shall satisfy itself that the proposed research can be conducted in accordance with all ethical and legal requirements, to appropriate internationally recognised standards[2], and that risks have been appropriately identified, and, where possible, mitigated. The Committee may take in to consideration: (i) a risk assessment conducted by the Contracts and Sponsorship Manager (as the sponsor representative) with the Chief
   Investigator (in the form included at Appendix 2); (ii) a statement of compliance (in the form included at Appendix 3); (iii) review of clinical trial documentation, including the protocol, information sheet and consent form; and (iv) may request the Chief Investigator to attend a meeting of the Committee. Where a proposed clinical trial is deemed to present particular risks to the University or is proposed to be conducted outside of previously established arrangements, the Committee may request to review the arrangements for the conduct of the study at an early stage, including prior to an application for funding.
5. The Committee shall be notified of clinical trials meeting the criteria set out in (1) submitted for funding and those funded.
6. The Committee shall review reports of clinical trials meeting the criteria set out in (1) in progress, to  include, but not limited to, information on recruitment to target, summary safety information and reports of meetings of a trial Data and Safety Monitoring Board. Urgent safety measures shall be communicated to the Committee as urgent business. The completion of clinical trials shall be notified to the Committee.
7. The Committee shall be notified of other clinical trials sponsored by the University not meeting the criteria set out in (1) (as set out in section B of Appendix 1) at the earliest opportunity, either before the start of the clinical trial or at the next available meeting.
8. Clinical or health research outside the scope of these terms of reference is set out in section C of Appendix 1[3].
9. The Committee shall meet at least on three occasions per annum and conduct urgent business electronically, or by arrangement of additional meetings, in the interim.
10. The Committee shall provide the minutes of its meetings to the University Research Committee and the Academic Ethics and Compliance Committee.

[1] https://www.york.ac.uk/staff/research/governance/research-policies/policy-for-clinical-research/
[2] ICH E6(R2) Good Clinical Practice https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice
[3] Considerations under the University’s Code of practice and principles for good ethical governance (https://www.york.ac.uk/staff/research/governance/research-policies/ethics-code/) and key legal requirements set out in Appendix 1 apply to the conduct of all research involving human participants. 

Full Terms of Reference including appendices: Terms of Reference - Clinical Trials Sponsorship Committee (PDF , 361kb)

Membership

Membership 

• Chair
• Director of Research, HYMS
• Director of York Trials Unit
• Director of Research, Innovation and Knowledge Exchange (or delegate)
• At least one University clinical academic
• One representative from the R&D Unit, York Teaching Hospitals NHS Foundation Trust
• At least one other representative from York Trials Unit
• Contracts and Sponsorship Manager (sponsor representative), Research, Innovation and Knowledge Exchange
• Other University academics (clinical or non-clinical) expert in regulatory requirements applicable to the conduct of clinical trials or research, clinical trial design, management or conduct.

(quorate would be 50% of the membership including the Chair)

Current membership (October 2022)

Definitions

Definitions

Definitions taken from glossary of the Medical Research Council Experimental Medicine Toolkit.

Sponsor

An individual, company, institution or organisation which takes responsibility for the initiation, management and/or financing of a clinical trial (from the EU Directive 2001/20/EC).

Clinical Trial

A clinical trial is any prospective evaluation of a healthcare intervention, which involves the administration of a treatment or type of management, including diagnosis or the provision of lifestyle (eg dietary) advice.

CTIMP

Clinical Trial of an Investigational Medicinal Product, ie a clinical trial that is within the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004.

IMP

An Investigational Medicinal Product is a pharmaceutical form of an active substance or placebo being tested or used as a reference in a CTIMP. This includes products already with a marketing authorisation: when used or assembled (formulated or packaged) in a way different from the authorised form, when used for an unauthorised indication, or when used to gain further information about the authorised form.