What is an "investigator's brochure"?

An investigator's brochure is a comprehensive document that contains critical information about an investigational product, which may include data from both clinical and nonclinical studies. Its primary purpose is to provide investigators, ethics committees, and regulatory authorities with detailed information that is vital for understanding the product's safety profile and the rationale behind its development.

This document typically includes information on the product’s chemical composition, mechanisms of action, preclinical studies, and any prior human studies, along with their findings. By summarizing this information, the investigator's brochure supports informed decision-making and ethical considerations in the conduct of clinical trials.

The other options do not accurately describe the purpose or content of an investigator's brochure. While financial summaries, lists of researchers, and regulatory submissions are important documents in the research process, they do not encapsulate the breadth of information typically found in an investigator's brochure, which specifically focuses on the investigational product itself.