Fatal or life-threatening unexpected ADRs must be reported to regulatory authorities within what timeframe after first knowledge?

• A. 30 calendar days.
• B. 7 calendar days.
• C. 15 calendar days.
• D. 60 calendar days.

Answer: (B)

Fatal or life-threatening unexpected adverse drug reactions are reported as SUSARs and must be reported to regulatory authorities within seven calendar days of the investigator first becoming aware of the event. This tight timeline ensures regulators receive urgent safety information quickly to protect participants and assess whether trial actions are needed. The other timeframes would delay communication and are not appropriate for such critical safety signals.