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.