Certified Clinical Research Associate (CCRA) Practice Exam 2026 – Complete Preparation Guide

Clinical trial data must be stored for a specified duration after the study close-out to ensure compliance with regulatory requirements and to maintain the integrity of the research. In most cases, the data is required to be retained for at least two years following the completion of the study. This is in line with guidelines established by various regulatory bodies, including the FDA and ICH GCP, which emphasize the importance of preserving trial data to allow for proper scrutiny and review, if necessary.

The stipulation for permanent storage can come into play depending on specific regulatory, sponsor, or ethical considerations, particularly if there is a potential for long-term follow-up, safety monitoring, or further scientific investigation stemming from the study. This highlights the need for a nuanced understanding of the storage requirements that may extend beyond the minimum timeframe recommended by regulatory frameworks.

While other options suggest varying durations, they either do not align with the most common regulatory standards or imply shorter retention periods which do not adequately support the thorough oversight necessary for clinical research integrity.