Who keeps the Subject Identification Code List, a confidential list of names of all subjects allocated to trial numbers and the ability to reveal identity when needed?

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

Answer: (B)

In clinical trials, a confidential link exists between each subject’s trial number and their real identity, kept separate from the coded data. This Subject Identification Code List is maintained by the sponsor, so that identities can be revealed if needed for safety reporting or regulatory purposes, while the rest of the data remain coded to protect confidentiality. This separation preserves participant privacy but allows re-identification when necessary. The other items—logging IP accountability, logging visits, or recording consent—address different aspects of trial management and do not provide the identity linkage or re-identification capability.