Investigator Brochure (IB)

The requirements for the creation, content, and updating of an Investigator Brochure (IB).

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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.

The IB should be concise, balanced, non-promotional, and updated/validated at least once a year.

This SOP applies to all clinical trials sponsored, co-sponsored or managed by King’s Health Partners (KHP) organisations where an IB is required.

For licensed products, a current Summary of Product Characteristics (SmPC) may be used instead of an IB, if appropriate.

Investigator Brochure Standard Operating Procedure

 

Investigator Brochure SOP

Supporting documents

Investigator Brochure Table of Contents

Investigator Brochure Receipt

Version control guidelines (Investigator Brochure)