Definitions for "Investigator's Brochure"
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