Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

Identifying a subject by their subject identification number is crucial in clinical trial reporting, particularly after a serious adverse event. This practice ensures the confidentiality and privacy of the subject while still allowing researchers to track and analyze their data accurately. The subject identification number is unique to each participant in a study, providing a systematic way to refer to individuals without disclosing their personal information.

Using this number also helps maintain the integrity of the data. It allows investigators to efficiently manage the data associated with each subject throughout the trial, especially in the case of adverse events that require detailed documentation and follow-up. This level of organization is particularly important in regulatory submissions, as it allows reviewers to connect the event back to specific trial data without compromising participant confidentiality.

In contrast, identifying a subject by their name or age could potentially violate privacy regulations and ethical guidelines surrounding human subject research. Similarly, while a medical record number could serve as a unique identifier in a healthcare setting, it may not necessarily correspond to the subject's participation in a particular clinical trial and could expose other unrelated medical information. Therefore, the use of the subject identification number is the most appropriate and standardized method for identification in this context.