Good Clinical Practice E6 (R3) Practice Test

When a trial is terminated or suspended by the sponsor, the obligation is to promptly notify the IRB/IEC and regulatory authorities and provide an appropriate explanation. This ensures oversight bodies are aware of safety concerns, participant rights, and the trial’s impact on data integrity. The explanation should cover why termination or suspension is occurring, whether safety issues are involved, the expected duration, and how ongoing safety and data handling will be managed. Merely informing participants or making protocol changes does not meet this reporting duty, and timely oversight communication is essential for protecting participants and maintaining regulatory compliance.