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Clinical Trials Sponsorship Committee


Terms of Reference

Terms of Reference

  1. Take overall responsibility for policy and procedure relating to clinical trials, including development of such policies and procedures as appropriate
  2. Take overall responsibility for ensuring that the University fulfils its legal duties as Sponsor or Co-Sponsor, including the decision to Sponsor, Co-Sponsor or participate in a CTIMPs trial
  3. Be kept informed of non-MHRA regulated trials approved by RE

Information on this website should be read in conjunction with the University Policy for Clinical Research.

Contacts

Chair: Jo Horsburgh, Registrar and Secretary
Secretary: Michael Barber, 9435180, michael.barber@york.ac.uk

Reports to

University Research Committee

Frequency of meetings

The Committee shall meet on a twice-yearly basis and conduct urgent business electronically, or by arrangement of additional meetings, in the interim.

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 health care intervention, which involves the administration of a treatment or type of management, including diagnosis or the provision of lifestyle (e.g. dietary) advice.

CTIMP

Clinical Trial of an Investigational Medicinal Product, i.e. 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.

 

Issue date: September 2010, updated April 2016

Membership

Committee Membership

RefConstituency
1 Registrar and Secretary (Chair)
2 Dean of the Hull York Medical School (HYMS), or their representative
3 The Director of the York Clinical Trials Unit
4 The Director of the Research and Enterprise Office
5 The Contracts and Sponsorship Manager
6 Representative of the Research & Development office of the York teaching hopsital NHS Foundation Trust
7-12 Members of University of York or NEY NHS Alliance staff who are engaged in, or who have experience of, clinical trials

 

RefNameOrganisation
1 Dr David Duncan Registrar and Secretary
2 Professor Bill McGuire HYMS, Director of Research
3 Professor David Torgerson Health Sciences
4 Dr Mark Mortimer Research & Enterprise
5 Michael Barber Research & Enterprise
6 Deborah Philips York Teaching Hospitals NHS Foundation Trust
7 Professor Charles Lacey HYMS
8 Liz Allen HYMS
9 Sarah Cockayne Health Sciences
10 Andrew Foster Health Sciences
11 Carol Taylor York Teaching Hospitals NHS Foundation Trust

 

 

For Members

Additional documents and information are available to members of the research committee.

Contact details

Michael Barber
Contracts and Sponsorship Manager

Tel: 01904 435180