Which section addresses the reporting of reactions associated with active comparator or placebo treatment?

• A. E2A III.E
• B. E6
• C. E9
• D. E8

Answer: (A)

The reporting of reactions in trials that use an active comparator or placebo is addressed in the safety data management guidance, specifically in E2A, Section III.E. This part covers how investigators collect, classify, and report adverse events and suspected adverse reactions, including those occurring in control arms. It ensures that all safety signals are captured and reported in a timely, consistent way to the sponsor and regulatory authorities, with guidance on causality assessment and SUSAR reporting as applicable. Other sections focus on general conduct (E6), statistics (E9), or broader trial considerations (E8), but the targeted guidance for reporting adverse reactions in comparator arms is found in E2A III.E.