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CLINICAL TRIAL – QUESTIONNAIRE

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					                             CLINICAL TRIAL – QUESTIONNAIRE

                        (FOR INSTITUTION SPONSORED TRIALS ONLY)

                          Complete and return to the Insurance Officer

If the Trial is within the UK and refers to the following there is no need to complete this Questionnaire:

Trials solely based upon questionnaires, venepuncture, measurements of physiological processes or
collections of body secretions by non-invasive methods, or the administration by mouth of foods or
nutrients or variation of diet other than the administration of drugs or other food supplements.

Institution (sponsor)………………………………………………………………………………………………

Title of Trial…………………………………………………………………………………………………………

Number of research participants………….

1. Advise details of the Trial and attach copy of the Protocol submission to the Ethics Committee



2. Is the Trial to be held in UK?
   If “No” please provide full details             ……………………………………………………………….

3. Who will be involved in conducting the Trial? ……………………………………………………………….

    If medical practitioners are involved will they be covered
    by the MDU or other organisation?               ……………………………………………………………….

4. Does the Trial involved use of drugs or surgery?                         ………………………………….

5. Are any of the research participants known to be pregnant?               ………………………………….

6. Are any of the research participants under 5 years of age?               ………………………………….

7. Is the purpose of the Trial:
   a) investigating or participating in the methods of contraception?       ……………
   b) assisting with or altering the process of conception?                 ……………

8. Does the Trial involve genetic engineering?                              ……………

9. Will the Trial use a pharmaceutical product designed or manufactured
   by the Institution?                                                 ……………

10. Proposed commencement date AND period of the Trial              ……………………………………….…...

                 If any of the answers to 4 – 9 are “Yes” please provide full details


Signed ……………………………………..…                                   Dated ……………………………………………..


Definitions:

Clinical Trial means an investigation or series of investigations conducted on any person for a
Medicinal Purpose

Medicinal Purpose means treating or preventing disease, diagnosing disease or ascertaining the
existence degree of or extent of a physiological condition, assisting with or altering in any way the
process of conception or investigating or participating in methods of contraception inducing anaesthesia
otherwise preventing or interfering with the normal operation of a physiological function.

				
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