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.