Regulation 3A Sponsor’s responsibility for the investigator’s brochureF1

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

validate and update the investigator’s brochure at least once a year.