Investigator Brochure (IB)
Requirements for the creation, content, and updating of an Investigator Brochure.
The Investigator Brochure
The Investigator Brochure (IB) provides investigators with the clinical and non-clinical information needed to understand the rationale for the trial, assess risks and benefits, and manage participants safely in line with the protocol. This SOP applies to all clinical trials sponsored, co-sponsored or manage by King’s Health Partners (KHP) organisations where an IB is required.
The IB should be concise, balanced, non-promotional, and updated/validated at least once a year.
For licensed products, a current Summary of Product Characteristics (SmPC) may be used instead of an IB, if appropriate.