Trial Master File(TMF)| Case Report Form( CRF)
|A comprehensive collection of all essential documents and records that describe the planning, conduct, and management of a clinical trial. |A document used to collect data from each participant in a clinical trial, capturing all protocol-required information.|
|To ensure that the trial is conducted in compliance with regulatory requirements and Good Clinical Practice (GCP).|To systematically gather and record individual / participant data for analysis and reporting.|
|Includes protocols, investigator brochures, consent forms, regulatory approvals, monitoring reports, correspondence.|Includes demographic, medical history, treatment detalls, lab results, and adverse event reports for each participant.|
|Used by sponsors, regulatory authorities, and auditors to verify trial conduct compliance.|Used by clinical investigators and date managers to capture and verify participant data.|
|Maintained as a central repository of trial documents, often in both physical and electronic formats.|Maintained as part of participant records, typically in electronic data capture (EDC) systems.|