What term describes a unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name?

What term describes a unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name?

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

Answer: (A)

To protect participant confidentiality in trials, a unique subject identification code is assigned by the investigator to each subject. This code is used on all trial records and data forms in place of the subject’s name, so identifying information isn’t disclosed in analyses or reports. The actual identity is kept separately in a secure master list accessible only to appropriate personnel, allowing re-identification only as needed for safety or regulatory purposes. The other options don’t describe a privacy-preserving identifier: a site or trial location, or a reference to the subject’s well-being, doesn’t serve the purpose of protecting identity in data handling.

To protect participant confidentiality in trials, a unique subject identification code is assigned by the investigator to each subject. This code is used on all trial records and data forms in place of the subject’s name, so identifying information isn’t disclosed in analyses or reports. The actual identity is kept separately in a secure master list accessible only to appropriate personnel, allowing re-identification only as needed for safety or regulatory purposes. The other options don’t describe a privacy-preserving identifier: a site or trial location, or a reference to the subject’s well-being, doesn’t serve the purpose of protecting identity in data handling.