How should data reported to the sponsor be identified?

• A. By the participant's full name.
• B. By the site location only.
• C. By random numbers with no link to identity.
• D. By an unambiguous participant code that can be traced back to the identity of the participant.

Answer: (D)

The main idea is to identify data with a coded, traceable identifier rather than using a person’s name. Data reported to the sponsor should use an unambiguous participant code that uniquely corresponds to that participant, with a separate, secure linkage key kept by authorized personnel to re-identify if needed. This protects confidentiality in the dataset while still allowing a way to link back to the actual identity when appropriate for regulatory, safety, or study-management purposes. Using the full name would disclose identity, site location alone does not uniquely identify participants, and random numbers with no link to identity would prevent tracing back to the person if required.