If a deviation is implemented to eliminate an immediate hazard, what must be done?

• A. Wait until trial ends.
• B. Submit the deviation and reasons to IRB/IEC, sponsor, and regulatory authorities as appropriate.
• C. Only inform sponsor.
• D. Inform subjects only.

Answer: (B)

When a deviation is implemented to eliminate an immediate hazard, you must promptly submit the deviation and the rationale to the IRB/IEC, the sponsor, and any applicable regulatory authorities. This ensures that safety actions are reviewed, recorded, and overseen, while maintaining the trial’s integrity. Even though the action protects a participant, it is still a protocol departure that requires official notification and, if needed, follow-up actions such as protocol amendments or changes to consent. Waiting until the trial ends or informing only the sponsor does not provide the necessary oversight and accountability.