When the Investigator's Brochure is updated, what should IRB/IEC receive?

• A. The updated brochure.
• B. The site monitoring report.
• C. Adverse event log.
• D. The current Investigator's Brochure.

Answer: (D)

When the Investigator's Brochure is updated, the IRB/IEC needs the most up-to-date safety information to review the study’s risk/benefit and to ensure the consent process remains accurate. Providing the current Investigator's Brochure gives the IRB/IEC the latest data on adverse events, new dosing or monitoring recommendations, and any new inclusion criteria that could affect participant safety. Other documents like the site monitoring report or the adverse event log are important for oversight, but they do not replace the requirement to furnish the current, updated Investigator's Brochure to the IRB/IEC.