investigator's brochure

Details of the trial are also provided in other documents referenced in the protocol, such as an investigator's brochure.

Investigator's Brochure: Ademetionine 1,4-butanedisulfonate.

Investigator's brochure, a document summarizing pharmacological information about an investigational product ("IP" or "study drug")

In drug development, the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial.

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product).

"Unexpected" means that for an authorised (approved) medicinal product that the event is not described in the product's labeling, or in the case of an investigational (unapproved) product that the event is not listed in the Investigator's Brochure.

An IND must also include an Investigator's Brochure which is a document intended to educate the trial investigators of the significant facts about the trial drug they need to know to conduct their clinical trial with the least hazard to the subjects or patients who will be enrolled.