The Investigator’s Brochure (IB) is a comprehensive collection of clinical and nonclinical data on the investigational product(s) that are pertinent to the study in human subjects. It is designed to equip investigators and others involved in the trial with the necessary information to understand the rationale behind the protocol and to ensure their adherence to critical elements such as dosage, dosing frequency/interval, methods of administration, and safety monitoring procedures. The IB also offers guidance to support the clinical management of study subjects throughout the clinical trial. The information should be presented in a clear, concise, objective, balanced, and non-promotional manner, allowing clinicians or potential investigators to understand the data and independently assess the risk-benefit ratio of the proposed trial. Therefore, it is generally advisable for a medically qualified person to be involved in the editing of the IB, though the content should be approved by the disciplines responsible for generating the data described.

Read the original FDA guidance on Good Clinical Practice (GCP) and Investigator's Brochures here.