The Medicines for Human Use (Clinical Trials) Regulations 2004

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

(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 [F1 , or equivalent document,] 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.

Textual Amendments

F1 Words in Sch. 3 Pt. 1 para. 3(b) inserted (31.12.2020) by The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/744), regs. 1, 24(2); 2020 c. 1, Sch. 5 para. 1(1)