Which action should the investigator take if a trial is prematurely terminated or suspended?

• A. Delay informing subjects until sponsor approval
• B. Immediately inform trial subjects and assure appropriate therapy and follow-up, and inform regulatory authorities if required.
• C. Only inform the sponsor; do not inform regulatory authorities
• D. Terminate communication with IRB/IEC

Answer: (B)

When a trial is prematurely terminated or suspended, the priority is to protect participants and ensure proper oversight. The investigator must promptly inform trial subjects about the termination, explain what it means for their care, and arrange for any necessary therapy and follow-up. At the same time, report to the appropriate regulatory authorities if required by regulations, so the safety issue is reviewed and monitored. Delaying notification until sponsor approval risks patient safety and undermines ethical responsibilities. Limiting communication to the sponsor or terminating contact with the oversight IRB/IEC would leave participants uninformed and underprotected. So the best action is to inform subjects immediately and arrange continued care, with regulatory notification as required.