SUSARs require expedited reporting to regulatory authorities within what general timeframe?

• A. 7 days for fatal or life-threatening cases, 15 days for others
• B. 24 hours for all cases
• C. 30 days for all cases
• D. 60 days for all cases

Answer: (B)

SUSARs are reported to regulatory authorities on an expedited basis to allow rapid safety assessment and protection of participants. The standard timing is a split: fatal or life-threatening SUSARs should be reported within 7 calendar days of the investigator becoming aware of the event, while all other SUSARs should be reported within 15 calendar days. The idea is that the most severe, life-threatening cases receive the fastest alert, with less urgent cases given a bit more time to gather complete information. The 24-hour timeframe is not the general deadline for regulatory reporting to authorities; it may apply to initial safety communications within the sponsor or for urgent safety measures, but not to the formal regulatory submission. Thus, the typical answer reflects 7 days for fatal/life-threatening cases and 15 days for others.