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Governance & Sponsorship

The Sponsor is the organisation taking responsibility for securing the arrangements to initiate, manage and finance a study including provision of insurance and/or indemnity. The Sponsor is not necessarily the funder. A Sponsor is required for all types of clinical research. For CTIMPs this is described in the Medicines for Human Use (Clinical Trials) Act  (aka the UK Regulations). Some medical device research studies are subject to the Medical Device Regulations. For other types of clinical research the need for a Sponsor is described in the  Research Governance Framework (RGF) for Health and Community Care, Scotland.

The University of Dundee and/or NHS Tayside are willing to assume Sponsorship of a research study when it is appropriate to do so. The University or the Board must actively consent to act as Sponsor of a study.

If you would like the University and/or NHS Tayside to act as Sponsor for your particular study, contact a TASC Research Governance Manager (RGM).  You should do this as early as is possible (and usually after funding for the study is in place). If you wish to conduct unfunded research contact the RGM to discuss. A study protocol is required by the RGM before a Sponsorship Review can be conducted.

Sponsorship requires to be in place before any  further approvals are sought ie REC favourable opinion, MHRA authorisation, NHS R&D Management Approval or any others.

Key Contacts

 

Research Governance Manager Vera Nuritova f.nuritova@dundee.ac.uk  (0)1382 383877

Please make contact as early as possible, but as a minimum at the time of funding application in the case of Clinical Trials of Investigational Medicinal Products (CTIMPs) or at least 5 working days before submission of an IRAS REC application for all other types of clinical research.

Ongoing sponsorship is subject to the condition that substantial amendments to the study Protocol or other study documents are submitted to the Sponsor for approval, prior to submission to REC and the MHRA (if applicable). In addition, all Annual Progress Reports, Annual Safety Reports, End of TrialStudy Notifications and Final Reports to the REC and/or MHRA must be copied to the Sponsor.