The Investigator’s Brochure (IB) is a comprehensive document summarizing the body of information about an investigational medicinal product (or study drug) obtained during drug development. The IB is a document of critical importance throughout the drug development process and is at least annually updated with new information as it becomes available. The document provides the clinical investigator and others involved in clinical studies all information to facilitate their understanding of the rationale for the study and their compliance with key features of the study protocol (e.g. dose, dose frequency, methods of administration and safety monitoring). The IB therefore compiles all data relevant to studies of the investigational product in subjects gathered during preclinical and other clinical studies.
For medical devices, the IB contains the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. Updates to the IB, generated when new relevant information becomes available, should be provided to the investigators in a timely manner. Requirements for the IB are detailed in Annex XV (Chapter II, Section 2) of the Medical Devices Regulation (2017/745).