Investigator Brochure Update

An IB is usually revised and updated to include new information at least annually, if not more frequently, depending on the stage of development and the volume of new relevant information generated. If the clinical trial is not sponsored by the pharmaceutical company, but is sponsored by the investigator, the sponsor-investigator is responsible for obtaining any updates to the brochure from the commercial manufacturer and distributing the updates to the clinical sites. If the investigational product is provided by the sponsor-investigator, then he or she should provide the necessary information to the trial personnel. If a formal IB is impractical, the sponsor-investigator should provide an expanded background information section in the trial protocol as a substitute. This section must contain the minimum current information described in the ICH guideline.


The Principal Investigator conducting the study at each site is responsible for ensuring the current IB has been provided to the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) while the study is ongoing at their site. The IEC or IRB reviews the IB as part of its responsibilities in reviewing and approving the clinical trial protocol and the investigators conducting the study. New information may be so important that it should be communicated to the investigators, and possibly to the IRBs/IEBs before it is included in a revised IB.

When providing an updated IB to the IEC/IRB, it is common practice to provide a listing of the changes made between the previous and current version. It is often helpful to the study sites to provide the change history to help ensure the study staff are aware of the changes. It is important, therefore, to have a document control system in place to manage the editing and publishing process.

As part of the site management process for regulated studies, it is common practice to have the site sign and return a document indicating the updated IB has been received and reviewed. Documentation of IRB approval is also required to be maintained in the study files both at the study site and by the study sponsor.