If monitoring or auditing identifies serious and persistent noncompliance, what should the sponsor do?

• A. Terminate the investigator's participation and promptly notify regulatory authorities.
• B. Increase monitoring but allow continued participation.
• C. Log the issue without corrective action.
• D. Replace staff without addressing the investigator.

Answer: (A)

When monitoring or auditing reveals serious and persistent noncompliance, the sponsor must remove the investigator from participation and promptly inform regulatory authorities. This step protects study participants and preserves data integrity by stopping continued risk and ensuring oversight. Increasing monitoring or allowing continued participation does not adequately mitigate ongoing risk once noncompliance is both serious and persistent. Logging the issue or replacing staff without addressing the investigator also fails to resolve the core problem, which is that the investigator is not meeting essential GCP and protocol requirements.