The Medicines for Human Use (Clinical Trials) Regulations 2004 No. 1031

PART 1 U.K. INTRODUCTORY PROVISIONS

[F1 Sponsor’s responsibility for the investigator’s brochure U.K.

3A.   The sponsor of a clinical trial shall—

(a) ensure that the investigator’s brochure for that trial, and any update of that brochure, presents the information it contains in a concise, simple, objective, balanced and non-promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial; and

(b) validate and update the investigator’s brochure at least once a year.]

Textual Amendments

F1 Reg. 3A inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 4