If the investigator terminates or suspends a trial without prior agreement of the sponsor, what is required?

• A. Inform only the sponsor.
• B. Inform the sponsor and IRB/IEC only, without written explanation.
• C. Inform the sponsor and IRB/IEC and provide a detailed written explanation to both.
• D. Inform the institution only.

Answer: (C)

When a trial is terminated or suspended by the investigator, you must promptly inform both the sponsor and the IRB/IEC and provide a detailed written explanation to both. This ensures participant safety and rights are protected, and it gives oversight bodies a clear, documented understanding of why the trial stopped, what safety concerns exist (if any), and what steps will follow for participant care and data handling. The written explanation should cover the reasons for termination or suspension, any ongoing safety assessments, actions taken to protect participants, plans for notifying participants and transitioning care, and how essential documents and data will be managed. Informing only one party or omitting a written explanation would leave critical stakeholders without necessary information for proper oversight and decision-making.