Investigator's brochure

The Investigator's Brochure (IB) is a basic document which is required in a clinical trial of a new drug (that is, one not yet approved by regulatory authorities for sale), together with the clinical trial protocol. The IB contains both clinical and non-clinical data pertaining to the new drug. The pharmaceutical company sponsoring the study provides a copy to each principal investigator (local researcher) prior to the start of a clinical trial.

According to United States 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 its safety and effectiveness in humans, and
* a description of possible risks and adverse reactions to be anticipated, and the precautions or special monitoring that the investigator should take.

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

As part of its [http://www.fda.gov/cdrh/guidance-about.html#1 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. [http://www.fda.gov/cder/guidance/959fnl.pdf]

See also

* Directive 2001/20/EC (Europe)
* Directive 2005/28/EC (Europe)
* Clinical trial
* Investigational product
* Clinical site
* Clinical trial protocol
* Case Report Form
* Patient-reported outcome
* Clinical data acquisition
* Clinical research associate (CRA)
* Drug development

External links

* [http://www.fda.gov/oc/ohrt/irbs/informedconsent.html Guidance for Institutional Review Boards and Clinical Investigators] (FDA)
* [http://www.fda.gov/oc/ohrt/irbs/toc4.html Guidance for Institutional Review Boards and Clinical Investigators] (FDA)