![]() When new information relevant to the clinical trial becomes available, it should be communicated to the investigators, and possibly to the Institutional Review Boards (IRBs) prior to a scheduled revision of the IB. The IB should be reviewed at least annually and revised as necessary in compliance with a sponsor’s written procedures. In these cases, a basic product information brochure, package leaflet or an expanded background information section in the trial protocol may be permitted by regulatory authorities as an alternative, provided that it includes current, comprehensive, and detailed information on all aspects of the investigational product that might be of importance to the investigator. When the investigational product is marketed and its pharmacology is widely understood by medical practitioners, an extensive IB may not be necessary. Information in the IB should be presented in a concise, simple, objective, balanced, and non-promotional form that enables a clinician, or potential investigator, to understand it and make his/her own unbiased risk-benefit assessment of the appropriateness of the proposed trial. The purpose of the IB is to compile data relevant to studies of the investigational product in human subjects gathered during preclinical and other clinical trials to provide the investigator with information necessary for the management of study conduct and study subjects throughout a clinical trial.Īn IB facilitates understanding of the rationale for, and their compliance with, many key features of the protocol, such as: ![]() The IB is a document of critical importance throughout the drug development process and is updated with new information as it becomes available. The Investigator’s Brochure (IB) is a comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device or other product) maintained by a drug developer or investigator that contains the body of information about the investigational product obtained before and during a drug trial. Programs of Research and Scholarly Excellence.
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