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PLANREFERENCE OUTLINE
Trial Master File (TMF) Index
TMF index structuring essential documents by zone/section with an expected-document list and completeness tracking, so the TMF stays inspection-ready. Maps to ICH E6(R3) and the EMA TMF guideline.
REGULATIONS MAPPED
ICH E6(R3)EMA TMF Guideline
DOCUMENT TYPE
PlanLAST UPDATED
January 2025PURPOSE
A trial master file index that structures the essential documents demonstrating a clinical trial was conducted to GCP — organised so the TMF is inspection-ready and complete throughout the trial.
What's Inside
✓TMF zone and section structure
✓Essential document expected-list
✓Sponsor / investigator file split
✓Completeness and QC tracking
✓Archiving and retention plan
How to Use It
1Adopt the zone/section structure for the TMF
2Map each essential document to its section
3Track expected vs. present for completeness
4QC contemporaneously, not at study end
5Define archiving and retention up front
DOCUMENT CONTENTS
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1TMF Structure and Zones
2Trial Management Essential Documents
3Regulatory and Ethics Documents
4Investigational Product Documents
5Site and Monitoring Documents
6Completeness / QC Tracker
7Archiving and Retention Plan
REGULATORY CONTEXT
ICH E6(R3) requires a trial master file of essential documents kept current, and the EMA TMF guideline frames structure and completeness. This index makes ongoing completeness visible and inspectable.