Who maintains the confidential Subject Identification Code List?

• A. Sponsor
• B. Investigator/Institution
• C. IRB
• D. FDA

Answer: (B)

When data is stored for a clinical trial, subjects are assigned unique codes so their identities aren’t exposed in analyses. The confidential Subject Identification Code List is the key that links those codes back to the actual identities, and it must be kept secure by the party that has ongoing contact with the subject—the investigator and the institution where the trial is conducted. This arrangement lets the investigator re-identify a subject if needed for safety follow-up, regulatory reporting, or other essential follow-up, while protecting privacy in the published data and in secondary analyses.

The sponsor typically receives data coded with the subject codes and does not rely on the master list for day-to-day care; the IRB oversees protections but doesn’t maintain the re-identification key as part of ongoing trial operations; the FDA inspects and reviews data but does not maintain the confidential re-identification list. Therefore, the investigator/institution maintains the confidential Subject Identification Code List.