To preserve confidentiality, which identification method should be used in SAE reporting?

• A. The subjects' real names.
• B. The subjects' addresses.
• C. Unique code numbers assigned to trial subjects.
• D. The subjects' phone numbers.

Answer: (C)

Protecting participant privacy in SAE reporting is achieved by using coded identifiers rather than direct personal details. Replacing real names, addresses, or phone numbers with unique code numbers allows investigators and regulators to track and clarify safety events without exposing who the subjects are. The code key that links codes to actual identities is kept securely by authorized personnel, so the data remain identifiable only to those who need it while the published or shared safety information remains de-identified. This approach aligns with GCP and privacy principles, enabling effective safety monitoring without compromising confidentiality. Using direct identifiers in SAE reports would risk exposing participants’ identities and breach confidentiality.