A Trial Master File (TMF) is a collection of essential documents that support the conduct of a clinical trial. It includes information such as study protocols, informed consent forms, and regulatory approvals. The TMF ensures that all necessary documentation is organized and accessible for review by regulatory authorities and sponsors. Maintaining a complete and accurate TMF is crucial for compliance with regulations set by organizations like the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A well-managed TMF helps facilitate audits and inspections, ensuring that the clinical trial is conducted ethically and in accordance with established guidelines.