Investigator’s Brochure

Investigator’s Brochure

The investigator’s brochure is a “compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.” (ICH E6).

In general, the investigator’s brochure provides more complete background information on the investigational product than is provided in the protocol. The investigator’s brochure assists the investigator in interpreting and implementing the study protocol, and may be of particular importance in helping the investigator determine whether specific adverse events are unanticipated, and accordingly, when and how such events should be reported to the sponsor, IEC/ IRB, and regulators.

Source: ICH E6