Investigator’s Brochure (IB)

The IB is a comprehensive document summarizing the body of information about an investigational product (“IP” or “study drug”) obtained during a drug trial. The IB is critically important throughout the drug development process and is updated with new information as it becomes available.

• The purpose of the IB is to compile data relevant to studies of the investigational product in human subjects gathered during preclinical and other trials.
• An IB is intended to provide the investigator with insights necessary for management of study conduct and study subjects throughout a clinical trial.
• An IB may introduce key aspects and safety measures of a protocol, such as:
• Dose (of the study drug),
• Frequency of dosing interval,
• Methods of administration, and
• Safety monitoring procedures.
• The sponsor is responsible for keeping the information in the IB up-to-date. The IB should be reviewed annually and must be updated when any new and important information becomes available, such as when a drug has received marketing approval and can be prescribed for use commercially.