An Investigator Brochure (IB) is the core reference document that summarizes clinical and nonclinical information about an investigational product for investigators and study staff.
It typically includes pharmacology, toxicology, prior human experience, known risks, dosing information, and guidance for handling and safety monitoring. Investigators use the IB to support informed consent discussions and manage study-related risks at the site level. Oversight bodies rely on IB content to understand the product risk profile and the rationale for protocol safeguards. Keeping the IB current is essential for participant safety and compliant communication of new safety information.