What type of subject identification code should the sponsor use?

• A. A code that uses the subject's initials.
• B. An unambiguous subject identification code that allows identification of all data reported for each subject.
• C. The subject's full name.
• D. An acronym used for internal tracking.

Answer: (B)

The essential idea is to protect participant privacy while keeping data connected to the correct individual. Use a unique, unambiguous subject identification code that can be used to link all data reported for each subject across visits, tests, and records without revealing the person’s identity. This coded approach supports data integrity and audit trails.

Relying on a subject’s initials or full name would directly identify the person, which compromises confidentiality. An internal tracking acronym can be ambiguous or not uniquely tied to the subject’s data across different sources, increasing the risk of mix-ups. The stable, unique code ensures every data point for a subject can be identified and combined correctly, while the key that links the code to the actual identity is kept securely separate and access-controlled.