What is the CRC's role in AE/SAE reporting?

What is the CRC's role in AE/SAE reporting?

• A. Document, report per protocol, follow up until resolution.
• B. Only escalate to IRB if death.
• C. Record events in local log only.
• D. Classify all events as SAE automatically.

Answer: (A)

This item centers on how a CRC handles adverse event reporting in a trial. The correct approach is for the CRC to document each event clearly in the source records, report it to the sponsor and the study team per the protocol’s defined timelines, and pursue follow-up information until the event is resolved or its outcome is known. This ensures safety data are captured accurately, regulatory requirements are met, and all necessary parties stay informed as the situation evolves. The other options miss key elements: reporting only in limited circumstances or logging locally without required dissemination, and automatically classifying every event as an SAE.

This item centers on how a CRC handles adverse event reporting in a trial. The correct approach is for the CRC to document each event clearly in the source records, report it to the sponsor and the study team per the protocol’s defined timelines, and pursue follow-up information until the event is resolved or its outcome is known. This ensures safety data are captured accurately, regulatory requirements are met, and all necessary parties stay informed as the situation evolves. The other options miss key elements: reporting only in limited circumstances or logging locally without required dissemination, and automatically classifying every event as an SAE.