Free Tools to Assess eTMF Health
Practical, No-Cost Resources for TMF Oversight and Inspection Readiness
Your Trial Master File (TMF) is more than a clinical record / document repository—it’s the official story of your study. And under the finalized ICH E6(R3) guideline, it must be managed with risk-proportionate oversight that extends beyond completeness to include quality, timeliness, and process control.
So how do you know if your eTMF is healthy?
At Just in Time GCP, we’ve developed a free, sponsor-friendly toolkit to help you evaluate and improve your eTMF oversight—no sales pressure, no software demo, just expert-built tools designed for the real world of clinical operations.
Start with the TMF Grading Tool
Curious how your TMF measures up?
This quick 5-question check-in helps you get a clear, no-pressure snapshot of your eTMF’s health—based on the criteria sponsors are most often evaluated against during inspection.
You’ll receive a simple grade with insights across completeness, quality, timeliness, and oversight—plus an optional follow-up summary and strategy session if you want to go deeper.
We ask for your name and email so we can send your personalized TMF Wellness Summary and follow up only if you find value in the results. Your information is never shared—and there’s no sales pitch attached.
TMF Red Flag Checklist
Identify common TMF oversight issues before they derail inspections
Use this practical checklist to uncover risk signals that often go unaddressed, including:
Inconsistent or missing metadata
Rejected uploads or delays in classification
Lack of audit trail for partner deliverables
No escalation pathway for repeated QC failures
Whether you’re overseeing your TMF internally or relying on a CRO, this checklist keeps critical quality factors front and center.
Receive Your TMF Wellness Summary
After completing the TMF Grading Tool, get a personalized report that breaks down your results and outlines next steps for achieving an inspection-prepared TMF.
Use it as an internal reference or to kick off improvement discussions across your TMF oversight team.
Schedule a Strategy Session with TMF Experts
Book a complimentary session with a clinical compliance expert to:
Review your TMF Grading Tool results
Discuss alignment with ICH E6(R3) expectations
Explore practical improvements across documentation, systems, and oversight
Understand how risk-proportionate TMF QC strategies can reduce audit risk
Why Your TMF Needs a Health Check
Under the updated ICH E6(R3) guidance, Trial Master File quality is no longer just about being “complete.” Sponsors must now show evidence of:
Risk-informed sampling and QC thresholds
Real-time oversight and escalation pathways
Accurate classification and metadata assignment
Audit-ready documentation throughout the trial
Waiting can be more costly, so get a pulse check on your TMF now — and take the first step toward inspection readiness and clinical trial documentation excellence.
