If the sponsor terminates or suspends a trial, what is the investigator's obligation?

• A. Promptly inform the institution and ignore IRB/IEC
• B. Only inform the sponsor.
• C. Respect the sponsor's decision and wait for further instructions.
• D. Promptly inform the institutions where applicable and promptly inform the IRB/IEC; provide the IRB/IEC a detailed written explanation.

Answer: (D)

When a trial is terminated or suspended, the investigator must ensure proper oversight and subject protection by communicating quickly with the right bodies and documenting the rationale. Specifically, inform the participating institution(s) and the IRB/IEC promptly, and provide the IRB/IEC with a detailed written explanation of why the study was halted or ended, what will happen next, and any steps being taken to protect current and future subjects. This keeps the ethical review process informed, allows the IRB/IEC to reassess risk, and supports appropriate actions at the site(s).

Delaying or limiting communication is not appropriate, and simply waiting for the sponsor’s instructions or only notifying the sponsor would leave subject safety and regulatory oversight at risk.