TMF
Medical abbreviation · Medical Research
| Stands for | Trial master file |
|---|---|
| Categories | Medical |
TMF stands for Trial master file, a medical research abbreviation.
Collection of essential documents that allows a clinical trial's conduct and data quality to be reconstructed and evaluated, including protocols, approvals, consent versions, training records, monitoring reports and correspondence. Sponsors keep the TMF, and sites keep an investigator site file.
Example: Inspection readiness check: the eTMF is missing two signed delegation logs.
Usage notes
Most sponsors now use an electronic TMF, often organized according to the industry TMF Reference Model. Regulators inspect the TMF to verify GCP compliance, and missing documents are a common inspection finding. Records must be retained for years after a trial ends.
Related abbreviations
More medical research abbreviations
- 510(k) – Premarket notification (FDA section 510(k))
- AHRQ – Agency for Healthcare Research and Quality
- ARR – Absolute risk reduction
- AUC – Area under the receiver operating characteristic curve
- BTD – Breakthrough therapy designation
- CBER – Center for Biologics Evaluation and Research
- CDER – Center for Drug Evaluation and Research
- CEA – Cost-effectiveness analysis
- CI – Confidence interval
- CITI – Collaborative Institutional Training Initiative
- COI – Conflict of interest
- CONSORT – Consolidated Standards of Reporting Trials
See all 94 medical research abbreviations →
This entry is for general education and is not medical advice. Abbreviation use varies between institutions; always confirm in context.