IB

The Investigator’s Brochure (IB) is a critical document in clinical trials that compiles all clinical and non-clinical data about an investigational product (such as a drug, device, or supplement) according to regulation EU No 536/2014. Its primary purpose is to ensures that investigators have comprehensive knowledge of the investigational product to safeguard participants and maintain compliance throughout the trial process.

The information should be presented in a concise, simple, objective, balanced and non-promotional manner so an Investigator has a clear understanding and can make their own unbiased risk-benefit assessment. A medically qualified professional should be involved in the editing process of the Investigator’s Brochure. The available non-clinical and clinical information on an IMP should be adequate to support the proposed clinical trial.

The IB must be updated by the sponsor at least once a year.

When the IMP is already authorized in any EU Member State (MS), and the product is to be used in accordance with the terms of the Marketing Authorization (MA), the Summary of Product Characteristics (SmPC) may be used instead of an extensive IB.

The Content:

• Summarizes data from preclinical and clinical studies, including physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information.
• Includes a « Summary of Data and Guidance for the Investigator » section to outline potential risks, adverse reactions, and necessary precautions 
• Provides guidance on dose, frequency, methods of administration, and safety monitoring procedures