Investigator's brochure is a summary of the results of a preclinical testing of a medicine and a clinical trial of a medicinal product for medical use

Source: Russian Federation Law №61-FZ March 24, 2010 "On Circulation of Medicines"

Investigator's Brochure - 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

Source: CPMP/ICH/135/95 ICH topic E6 (R1) Note for guidance on good clinical practice