Investigator's Brochure

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The Investigator's Brochure' is a basic document which is required in a clinical trial, together with the clinical trial protocol. According to FDA regulations (Title 21 CFR 312.23) an Investigator's Brochure must contain:

a description of the drug substance and the formulation,
a summary of the pharmacological and toxicological effects,
a summary of information relating to safety and effectiveness in humans, and
a description of possible risks and side effects to be anticipated and precautions or special monitoring.

At the moment when a new drug enters a Phase I clincial trial, preclinical information about the pharmacological and toxicological effects and the pharmacokinetics and biological disposition in animals must be available in the Investigator's Brochure. As a drug candidate continues through Phase II and III clinical trials, information relating to safety and effectiveness in humans obtained from prior clinical studies must be included in the document. In addition possible risks and side effects to be anticipated on the basis of prior experience with the drug under investigation or with related drugs is to be included in the Investigator's Brochure.

As part of its guidance on Good clinical practice (GCP), the International Conference on Harmonisation (ICH) has prepared a detailed guidance for the contents of the Investigator's Brochure in the European Union, Japan, and the United States.[1]