Singapore legislation
Regulation 6
Regulation 6
Investigator’s brochure
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.