The sponsor should update the Investigator's Brochure in which scenario?

• A. Only at yearly intervals.
• B. As significant new information becomes available.
• C. When the trial ends.
• D. Only when regulatory demand exists.

Answer: (B)

Updates to the Investigator's Brochure should happen whenever significant new information becomes available that could affect participant safety or how the trial is conducted. The IB is a living document meant to reflect the most current understanding of the investigational product, so investigators have up-to-date risk-benefit information, dosing guidance, monitoring requirements, and safety data. If a new serious adverse event emerges, new pharmacokinetic or interaction data are reported, or new contraindications or monitoring recommendations are identified, an IB revision is needed to keep trial conduct safe and ethically sound. Relying on regulatory demand alone is not sufficient, and waiting for fixed intervals or at the trial’s end would deprive investigators of important information during the study.