TMF
TMF, or Trial Master File, is a collection of essential documents that support the conduct of a clinical trial. It includes records such as study protocols, informed consent forms, and regulatory approvals. The TMF ensures that all necessary information is organized and accessible for review by regulatory authorities and sponsors.
Maintaining a complete and accurate TMF is crucial for compliance with Good Clinical Practice (GCP) guidelines. A well-managed TMF helps facilitate audits and inspections, ensuring that the trial's integrity and participant safety are upheld throughout the research process.