A Five-Step Game Plan For A TMF Close-Out

Successfully closing out a clinical trial involves addressing numerous questions about the responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out is only permissible when the clinical research associate (CRA) confirms that all necessary documents are in the appropriate files. However, in practice, the responsibility often falls to TMF teams.

The complexities of trial protocols, varying study sites, and international regulations necessitate meticulous planning for TMF close-out. To streamline this process, we present a five-part game plan that simplifies this complex process, ensuring compliance and readiness for regulatory review. This structured approach ensures a smooth and compliant TMF close-out, meeting all ethical and regulatory requirements.