If a trial is prematurely terminated or suspended, what information should be promptly communicated?

• A. Only investigators and institutions.
• B. Investigators/institutions, regulatory authorities, and IRB/IEC, with reasons for termination or suspension, as required by regulations.
• C. Only regulatory authorities.
• D. Only the sponsor’s internal records.

Answer: (B)

When a trial is terminated or suspended, the responsible party must inform all those who oversee subject safety and the study’s ethical and regulatory standing. The notice should go to investigators and the institutions where the trial is conducted, regulatory authorities, and the IRB/IEC, and it must include the reasons for the termination or suspension. This ensures participants’ rights and safety are protected, that regulators can assess risk and respond appropriately, and that the ethics oversight body is aware of what happened and any actions planned. Notifying only one group or only keeping internal records would leave gaps in oversight and protection. Providing the reasons helps all parties understand the context, the impact on participants, and the steps being taken to safeguard them.