If the Investigator's Brochure is updated during the trial, what should be done?

• A. Ignore update.
• B. Stop trial.
• C. Supply updated Investigator's Brochure to the IRB/IEC.
• D. Only inform sponsor.

Answer: (C)

When new safety or other important information emerges during a trial, the Investigator's Brochure must be updated and the revised version provided to the IRB/IEC for review. This allows the ethics committee to reassess the study's risk/benefit profile in light of the latest data and determine whether any changes to the protocol, consent form, or participant information are needed. The update should be available to all investigators and sites, and, if the new information affects participant consent, the consent documents should be amended and participants re-consented. Simply ignoring the update, stopping the trial, or only informing the sponsor do not meet GCP responsibilities for ongoing ethical oversight and participant protection.