Investigator's brochure

Investigator’s brochure (IB) is a comprehensive document provided to clinical trial investigators containing detailed information about the investigational product being studied. It includes data on the product’s characteristics, including pharmacology, toxicology and pharmacokinetics, as well as product’s formulation, manufacturing and handling together with information on previous human experience.

Definitions

ICH E6(R2)

1.36 Investigator's Brochure:

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects .

Content of Investigator’s Brochure

Under 21 CFR 312.23(a)(5), the Investigator’s Brochure is a document that summarizes all relevant nonclinical and clinical information on the investigational drug that is necessary for its safe use in a clinical trial. It identifies the drug substance and formulation and, where known, provides basic chemical and pharmacological characteristics.

The Investigator’s Brochure compiles available data on:

• pharmacology
• toxicology
• pharmacokinetics
• prior human experience
• supporting publications included when appropriate

It also describes known and anticipated risks, side effects, and required precautions or monitoring, forming the basis for investigator awareness and ongoing trial conduct.

Distribution of safety information

Under 21 CFR 312.55, the sponsor is responsible for ensuring that each participating clinical investigator is adequately informed about the investigational drug.

The sponsor is also obligated to periodically inform investigators of new information on the investigational drug. This information may be distributed through updated Investigator’s Brochures or by other appropriate means, such as written communications or published materials.

See also

Another relevant pages

• IMP