Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

The label indicating the subject study number is a critical component in clinical trials, as it serves to uniquely identify each participant within the study. This uniquely assigned number facilitates tracking and managing subjects throughout all phases of the trial, ensuring that data collected is accurately attributed to the correct participants.

The requirement for a subject study number applies to all investigational drugs, spanning across all phases of clinical trials, not just limited to phase III. This consistency aids in maintaining the integrity of the study data, enhances accountability, and ensures compliance with regulatory standards. Proper identification through study numbers is essential for data management and subsequent analyses.

While the other options suggest alternative approaches, they do not meet the regulatory standards required. For instance, it isn’t optional as accurate tracking is essential in clinical research. Furthermore, it is not limited to only phase III trials; all phases require this information. Lastly, participant names cannot replace study numbers due to privacy concerns and the need for standardized identification in data management practices.