Investigator's Brochure (IB)

An Investigator's Brochure (IB) is a comprehensive document used in clinical research that provides detailed information about a new medical product or drug. It includes data from previous studies, potential risks, how it works, and how to use it safely. The IB helps doctors and researchers understand the treatment thoroughly, ensuring they can conduct the study responsibly and protect patients. It serves as an essential reference to ensure the clinical trial is conducted ethically and safely, while also helping investigators make informed decisions throughout the research process.