Swansea University

Clinical Trials and Insurance Issues

Want to find out more about Clinical Trial coverage or what to put on your LREC form regarding indemnities? The following information should help you.

Swansea University has automatic cover for all research and Clinical Trials except those on the Clinical Trial Exclusion List .

If you are involved in Clinical Trial Research you should be made aware that any trials which include something on the aforementioned list must be referred to our insurers via the Insurance Administrator, Alison Spence. Contact her by e-mail, a.j.spence@swansea.ac.uk or by telephone on +44 (0)1792(29)5434.

Our insurance providers, UMAL, have devised an updated methodology that must be used by SU staff to inform them when a Trial is to be undertaken. Please note:-

1. A Questionnaire will require completion for any projects that go before the MHRA except, but only, if they fall into the referral categories noted on Form CT09A .

2. For research projects that do not need MHRA approval, but nonetheless may be considered Research involving Human Participants according to the insurer's definition, Form CT09B should be used.

Any completed Questionnaire should be returned to the Insurance Administrator, in the first instance. It is then sent onto our insurers for discussion by underwriters and may also involve an additional premium for cover, payable by the department undertaking the research.