Regulation 4 Insertion of regulation 3A of the principal Regulations

After regulation 3 of the principal Regulations (sponsor of a clinical trial) insert the following regulation—

“Sponsor’s responsibility for the investigator’s brochure

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.”.