What is required before initiating a trial regarding Investigator's Brochure?

• A. A current copy of the Investigator's Brochure must be provided with the initial application, and updated copies supplied if the brochure is updated.
• B. Brochure is optional.
• C. Provided only after the trial begins.
• D. Kept by the sponsor only.

Answer: (A)

Before starting a trial, investigators must have access to the latest safety and clinical data on the investigational product through the Investigator’s Brochure. The sponsor is responsible for providing a current copy of the IB with the initial application and supplying updated copies whenever the brochure is revised. This guarantees that investigators have up-to-date information about risks, indications, and study procedures to protect participants. The IB should be available at the trial site before enrollment begins and kept current throughout the study. Options suggesting the brochure is optional, provided only after the trial starts, or kept only by the sponsor do not meet GCP requirements because they would leave investigators without timely, critical information.