Which step best describes what a CRC must do after identifying an adverse event?

• A. Notify only the participant.
• B. Immediately terminate enrollment.
• C. File away without action.
• D. Document, report per protocol, follow up to resolution.

Answer: (D)

When a CRC identifies an adverse event, the essential action is to document it clearly, report it according to the protocol, and follow up until it resolves. This approach ensures that the event is formally recorded in the participant’s records and the case report form, promptly communicated to the study team and sponsor as required, and monitored to see that any necessary safety actions are taken and that the event is resolved or properly determined to be unrelated. This safeguards participant safety and maintains the integrity of the trial data.

Notifying only the participant misses the critical steps of documentation and reporting to the study team. Immediate termination of enrollment is not an automatic response to every adverse event and is only appropriate if predefined stopping criteria are met. Filing the event away without any action neglects required documentation and ongoing safety monitoring.