What is the purpose of the Subject Identification Code List?

• A. To log visits
• B. To log IP accountability
• C. To keep confidential list of names of all subjects allocated to trial numbers, and to reveal identity of any subject
• D. To report adverse events

Answer: (C)

In practice, the Subject Identification Code List is kept to protect subject privacy while still allowing tracing if needed. It securely maps each subject’s coded trial number to the person’s real identity, so data in the study records can be analyzed without exposing names. Access to this list is restricted to authorized personnel, and it is stored separately from the study data. This way, re-identification is possible only when necessary (for safety follow-up, regulatory requests, or other legitimate needs) without revealing identities in the primary data. It isn’t used for logging visits, IP accountability, or adverse events, which are handled in other records and systems.