Regulation 6
Investigator’s brochure
of Medicines (Clinical Trials) Regulations 2016
Subsidiary LegislationIn forceProvision 6 of 31
Regulation 6
The sponsor of a proposed clinical trial must ensure that the investigator’s brochure for the trial —
(a)
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 trial; and
(b)
is kept up-to-date.