What is the purpose of the sponsor notifying investigators of safety information?

• A. To log IP usage
• B. To inform investigators of safety information
• C. To identify the SAEs
• D. To request updated demographics

Answer: (B)

Communicating safety information to investigators is essential so they can protect study participants. When safety data emerge—such as adverse events or new risk signals—the sponsor provides investigators with the relevant details, the sponsor’s assessment, and any recommended actions. This enables investigators to re-evaluate participant safety, adjust monitoring or procedures, update the informed consent if needed, implement risk-minimizing measures, or pause/stop the study if safety concerns arise. This is about maintaining participant safety and appropriate risk response, not about logging IP usage, identifying SAEs, or requesting demographics.