Trial Master File

A Trial Master File (TMF) is an organized collection of essential documents and records related to a clinical trial. It serves as a central repository to ensure compliance with regulatory requirements and provides transparency throughout the trial process. The TMF includes documents like study protocols, informed consent forms, reports, and correspondence. It helps researchers, sponsors, and regulators track the progress of the trial, ensure data integrity, and facilitate audits. Essentially, the TMF acts as a comprehensive archive that captures all vital information necessary for the successful management and evaluation of a clinical study.