In GCP, what is the primary reason for maintaining a clinical trial master file?

Maintaining a clinical trial master file is essential for ensuring transparency and facilitating compliance with regulations. This file serves as a comprehensive repository of all essential documents related to the clinical trial, including protocol, informed consent forms, study reports, and subject information. The presence of a well-organized master file demonstrates compliance with Good Clinical Practice guidelines and regulatory requirements established by agencies such as the FDA or EMA.

In the context of audit and inspection, regulators expect a clear and accessible trail of documentation that confirms the trial was conducted ethically and in accordance with approved protocols. The master file provides the necessary evidence to support this accountability. Thus, it plays a vital role in safeguarding participant rights, ensuring data integrity, and promoting public confidence in the research process. This functional aspect aligns with regulatory expectations and fosters an environment of transparency throughout the clinical trial phase.