For non-life-threatening SUSAR, the reporting deadline is:

For non-life-threatening SUSAR, the reporting deadline is:

• A. Within 24 hours after awareness
• B. No later than 7 days after awareness
• C. No later than 15 days after awareness
• D. Immediately upon awareness

Answer: (C)

A SUSAR is a suspected adverse reaction that is serious and unexpected, and it must be reported to the sponsor and the regulatory authorities within a defined timeframe. For non-life-threatening SUSARs, the allowed window is up to 15 days after the sponsor or investigator becomes aware of the event. This timing balances the need to promptly inform regulators with giving enough time to verify the event and collect necessary details. Immediate reporting isn’t required because the report should be complete and accurate, not rushed. In contrast, life-threatening or fatal SUSARs require faster reporting (typically within 7 days) due to the higher immediate risk to participants. Awareness refers to when the event is recognized as a SUSAR, not when it occurred.

A SUSAR is a suspected adverse reaction that is serious and unexpected, and it must be reported to the sponsor and the regulatory authorities within a defined timeframe. For non-life-threatening SUSARs, the allowed window is up to 15 days after the sponsor or investigator becomes aware of the event. This timing balances the need to promptly inform regulators with giving enough time to verify the event and collect necessary details.

Immediate reporting isn’t required because the report should be complete and accurate, not rushed. In contrast, life-threatening or fatal SUSARs require faster reporting (typically within 7 days) due to the higher immediate risk to participants. Awareness refers to when the event is recognized as a SUSAR, not when it occurred.