What is the primary purpose of expedited SUSAR reporting to regulatory authorities?

• A. To ensure participant safety and regulatory oversight
• B. To recruit more participants
• C. To shorten the trial
• D. To publish results early

Answer: (A)

Prompt and clear communication of serious and unexpected adverse reactions to regulators and ethics committees is the main purpose of expedited SUSAR reporting. This rapid notification supports participant safety by allowing regulators to assess risk across trials, identify new safety signals, and require immediate actions such as protocol changes, enhanced monitoring, informed consent updates, or trial stoppage if needed. It ensures ongoing regulatory oversight and risk management throughout the study. Recruitment, shortening the trial, or publishing results early are not the goals of SUSAR reporting.