In SAE reporting, how should subjects be identified?

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

Answer: (A)

In clinical trials, protecting participant privacy while keeping safety data traceable means using non-identifying codes to identify subjects in SAE reports. Unique code numbers assigned to trial subjects allow all SAEs to be linked to the same individual across different reports and time points without exposing personal information. The actual identities are kept in a secure linkage file accessible only to authorized personnel, while the SAE submissions to regulators or ethics committees contain only the coded ID. Names, addresses, or phone numbers should not appear in safety reports, as they would compromise confidentiality and are not needed for safety assessment. Using unique study codes thus provides both confidentiality and the necessary ability to follow up and aggregate safety information across the trial.