SCHEDULE 3PARTICULARS AND DOCUMENTS THAT MUST ACCOMPANY AN APPLICATION FOR AN ETHICS COMMITTEE OPINION, A REQUEST FOR AUTHORISATION, A NOTICE OF AMENDMENT AND A NOTIFICATION OF THE CONCLUSION OF A TRIAL

PART 1APPLICATION FOR ETHICS COMMITTEE OPINION

3

The following documents or, in each case, an explanation of why that document is not being provided—

a

the protocol;

b

the investigator’s brochure for the proposed trial or, where the investigational medicinal product has a marketing authorisation and the product is to be used in accordance with the terms of that authorisation, the summary of product characteristics relating to that product;

c

any document providing evidence of any insurance to cover the liability of the sponsor and investigator;

d

copies of the advertisement material for recruitment of research participants;

e

in the case of advertising contained on video or audio cassettes, a copy of the script for that advertising;

f

a copy of any letter inviting a subject to participate in the trial;

g

a copy of any questionnaire, diary or sample card to be completed by the subject in writing;

h

a copy of all written information to be given to a potential subject or their legal representative prior to seeking informed consent;

i

a copy of the form to be used to record the consent of a subject or their legal representative;

j

a copy of any letters or other written information to be sent to any person who normally provides a subject’s clinical care;

k

a summary curriculum vitae for the chief investigator and each investigator.