The Trial Master File (TMF) is the collection of essential documents that demonstrate a clinical trial was conducted in compliance with regulatory requirements and GCP.
The TMF includes approvals, monitoring documentation, safety reports, correspondence, contracts, training records, and vendor oversight artifacts. Regulators inspect the TMF to verify oversight, data integrity controls, and participant protections throughout the study lifecycle. An electronic TMF (eTMF) must support audit trails, access controls, and controlled document workflows. A complete, inspection-ready TMF is critical for regulatory submissions and successful audits.