A compilation of the clinical and non-clinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. It provides Principal Investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, methods of administration and safety monitoring procedures.

A document containing a summary of the clinical and non-clinical data relating to an investigational medicinal product which are relevant to the study of the product in human subjects.

a document provided by the sponsor to all investigators that compiles the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects

Relevant clinical and non-clinical data compiled on the investigational drug, biologic or device being studied.

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. (ICH)

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 brief description of the drug substance and the formulation. 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.