A unique identifier assigned by the investigator to protect subject identity when reporting trial data is called what?

• A. Subject/Trial Subject
• B. Trial Site
• C. Subject Identification Code
• D. Well-being (of the trial subjects)

Answer: (C)

Protecting participant privacy in trial reporting is achieved by using a coded identifier instead of direct personal information. The Subject Identification Code is the unique code assigned by the investigator to each participant. This code lets data be linked across visits and records for analysis while keeping the person’s identity confidential. The secure linking key that maps the code to the real identity is typically kept by the sponsor or a designated data management team. In data sets used for reporting, using this code reduces the risk of exposing personal information.

The other options don’t describe a coding system for protecting identity: a subject is the person, not an anonymized code; a trial site refers to where the study takes place; and well-being relates to the safety of the participants.