Good Clinical Practice (GCP) Practice Exam

What is the purpose of a Subject Identification Code?

1. To identify the trial site

2. To protect the subject's identity

3. To categorize the investigational product

4. To record research findings

The correct answer is: To protect the subject's identity

The purpose of a Subject Identification Code is fundamentally to protect the subject's identity throughout a clinical trial. This code allows researchers to track and manage data related to individual participants without revealing their personal information. By using a unique code assigned to each subject, trial sponsors and investigators can maintain confidentiality, which is critical for ethical considerations and regulatory compliance in clinical research. Maintaining the anonymity of subjects encourages participation by alleviating concerns about privacy, ensuring that sensitive information is kept secure. This practice is essential in adhering to Good Clinical Practice standards, which emphasize the importance of protecting the rights and well-being of trial participants. Other options, though relevant to trial operations, do not align with the primary function of the Subject Identification Code. Identifying the trial site pertains to the operational aspect of clinical trials, categorizing the investigational product relates to product management, and recording research findings has to do with data collection and reporting rather than participant confidentiality.