Which statement best describes when risk control measures should be reviewed?

• A. Only after a major protocol deviation occurs.
• B. Once at trial initiation and never again.
• C. Periodically, to ascertain their effectiveness and relevance, considering emerging knowledge and experience.
• D. Only when a regulatory audit is planned.

Answer: (C)

Continuous, periodic review of risk control measures is essential because risk management in trials is an ongoing process. As new information emerges—from safety data, literature, protocol changes, or experiences at sites—the controls in place may need to be updated to remain effective and appropriate. This periodic check ensures that what is being done still aligns with the current understanding of risks and with regulatory expectations, and it allows adjustments to be made before problems arise.

Relying on a review only after a major protocol deviation is too reactive; waiting for deviations means opportunities to prevent issues may be missed. Checking risk controls only at trial initiation and never again ignores how the trial environment and knowledge evolve. Waiting until a regulatory audit is planned makes the review opportunistic rather than part of ongoing risk management.