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.