The purpose of the IB is to compile data relevant to studies of the IP in human subjects gathered during preclinical and other clinical trials.
An IB may introduce key aspects and safety measures of a clinical trial protocol, such as: An IB contains a "Summary of Data and Guidance for the Investigator" section, of which the overall aim is to "provide the investigator with a clear understanding of the possible risks and adverse reactions, and of the specific tests, observations, and precautions that may be needed for a clinical trial.
This understanding should be based on the available physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information on the investigational product(s).
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.
[1] (broken link) If many clinical trials have been completed, tables that summarize findings across the various studies can be very useful to demonstrate outcomes in, e.g., different patient populations or different indications.