Which entities should the sponsor promptly notify about findings that could affect subject safety, trial conduct, or the continued favorable opinion of the IRB/IEC?

• A. Investigators and institutions and regulatory authorities
• B. Only the IRB/IEC
• C. The sponsor's internal team only
• D. Subjects directly

Answer: (A)

Timely communication to the right oversight bodies and investigators is required when findings could affect subject safety, trial conduct, or the ethics board’s continued approval. The sponsor must promptly inform the investigators and the trial sites’ institutions so that immediate safety actions and protocol considerations can be addressed at the site. Regulatory authorities also need to be notified to ensure proper regulatory oversight, potential actions, or amendments as needed. The IRB/IEC must be informed to preserve its ongoing ethical oversight and review if the findings could impact its favorable opinion. Direct notification to subjects is typically handled by the investigators, not the sponsor alone. Therefore, notifying investigators and institutions, regulatory authorities, and the IRB/IEC is the appropriate course.