Clinical Trial Insurance Checklist

Guidance Notes for Researchers requiring Clinical Trials Insurance

These notes are provided to answer some of the common queries University of Cambridge researchers have about the Clinical Trials Insurance, which can be arranged by the University of Cambridge Insurance Section. The process for arranging Clinical Trials Insurance is by completion of a checklist prior to submission of trial papers to LREC, and completion of a ‘commencement form’ prior to the start of the trial. These forms can be obtained from the Insurance Section (tel: 01223 332216 or 339659). Confirmation of insurance will be provided by formal letter and must not be assumed.

How is a Clinical Trial defined?

The Clinical Trials Insurance Policy definition of a Clinical Trial is as follows:

A Clinical Trial is an investigation or series of investigations conducted on any person for a medicinal purpose, meaning:

 treating or preventing disease;  diagnosing disease or ascertaining the existence, degree or extent of a physiological or psychological condition;  assisting with or altering in any way the process of conception or participating in methods of contraception (BUT see “Which Trials Are Excluded From Automatic Cover?” below);  inducing anaesthesia;  otherwise preventing or interfering with the normal operation of a physiological or psychological condition.

This definition is a wider definition than that of the Medicines for Human Use (Clinical Trials) Regulations 2004. The main areas where the definitions are wider under the insurance policy are for drafting protocols, treatments such as physiotherapy and data analysis.

What is a Drug Trial?

Insurers (RSA) consider a drug trial to be any investigation involving a medicinal substance that requires a Clinical Trial Authorisation from the MHRA under the Medicines for Human Use (Clinical Trials) Regulations 2004.

Which Trials Are Excluded From Automatic Cover?

Insurers aim is to provide protection for Clinical Trials work. However, the Clinical Trials insurance policy does exclude certain trials which require special consideration and referral to insurers:

 large scale Trials involving more than 1000 Research Subjects;  trials involving children under 5 years of age;  genetic trials for non-medical purposes;  trials involving conception or contraception;  trials involving pregnant women;  trials involving Research Subjects who are resident outside Great Britain, Northern Ireland, the Channel Islands or the Isle of Man;  trials where the substance (or equipment) under investigation has been designed and/or manufactured by the Insured (in this case the University).

Sometimes insurers will agree to provide cover for such trials at additional cost, but insurers will always require individual notification in advance, with full details (e.g. trial protocol, ethics application, patient information sheet and consent form). For these trials cover is not provided unless the insurers specifically agree in writing.

Trials which insurers generally regard as being unacceptable are:

 any trial where the University designs, manufactures or makes up the drug used in the trial.

All other Trials

These are all other clinical trials which do not fall into any of the above categories. CLINICAL TRIAL INSURANCE CHECKLIST

University Department : Insurance Reference (to be added by Insurance Section) : Chief Investigator for University : Title of Trial : Expected Commencement Date : Sponsor(s) :

Please tick the appropriate box

1) Will the trial involve the use of research subjects outside Great Britain, Northern Ireland, the Channel Islands or the Isle of Man? Yes No

2) Will the trial involve assisting with or altering in any way the process of conception or investigating or participating in methods of contraception? Yes No

3) Will the trial involve research subjects known to be pregnant at the time of the trial? Yes No

4) Will the trial involve research subjects who will be under the age of 5 years at the time of the trial? Yes No

5) Will the trial involve genetic engineering where the purpose of such genetic engineering is NOT preventing or diagnosing disease? Yes No

6) Will the trial involve the use of a drug or medical device designed or manufactured by the University (such trials are generally unacceptable)? Yes No

7) Will the total number of research subjects exceed 1,000? Yes No

8) Will written informed consent be obtained either from the research subject or their legal guardian? Yes No

9) Is the trial being sponsored by a pharmaceutical manufacturer or similar commercial organisation? Yes No

10) If the answer to Q 9) is Yes, is an ABPI indemnity or equivalent indemnity being obtained? Yes No

If any of the answers to Q 1) – 7) are Yes, or the answer to Q 8 is No, the Trial may need to be submitted to Insurers for further consideration. To allow the Trial to be referred, please supply the following:

A) Full copy of the Trial Protocol and Ethics Committee approval, or other documentation describing the study B) A copy of any indemnity agreement from the commercial organisation sponsoring the trial where applicable C) Full details of all trial centre locations and numbers of trial subjects where such centres are outside the UK D) Details of the procedure and parties from whom consent will be obtained if the answer to Q 8) is No E) Any other information you consider will assist the Insurers’ understanding of the Trial and the contractual relationships

Please now return this form and a copy of the Trial Information Sheet to the Insurance Manager, University of Cambridge, Finance Division, Greenwich House, Madingley Road, Cambridge CB3 0TX.