The TMF tells the story of your trial — and a regulator who can't reconstruct that story from your TMF will assume the worst. A TMF audit verifies that essential documents are present, current, properly filed and inspection-ready, whether you run a paper TMF, an eTMF or a hybrid.
Audits can run periodically throughout the study (the best time to fix gaps) or as a focused pre-inspection check.
What the audit covers
- Completeness against the TMF Reference Model
- Timeliness and contemporaneousness of filing
- Document quality, versioning and signatures
- eTMF system controls and metadata
- Trial-, country- and site-level sections
- Reconciliation against expected documents
What you receive
- TMF audit plan and scope
- Gap analysis and risk-ranked report
- Remediation / CAPA support to close gaps
Why it matters
Incomplete or untimely TMFs are among the most common GCP inspection findings. Continuous TMF quality avoids a frantic reconstruction before an inspection — and demonstrates control of your study.
Standards & frameworks
Frequently asked questions
What is a TMF audit?
A TMF audit is an independent review of the trial master file to confirm that essential documents are complete, current, accurate and filed in a way that lets a regulator reconstruct the conduct of the trial.
How often should the TMF be audited?
Best practice is periodic, risk-based TMF reviews throughout the study rather than a single check at the end, so gaps are corrected while documents and people are still available.