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.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ICH E6(R3)EMA TMF Guideline
DOCUMENT TYPE
Plan
LAST UPDATED
January 2025
PURPOSE

The index that structures a trial master file so completeness is visible while the trial runs rather than reconstructed after it closes. TMF inspection findings are overwhelmingly about currency and completeness, not about missing documents that never existed — so the index tracks expected against present, and treats quality control as a contemporaneous activity rather than a close-out task.

What's Inside

✓TMF structure and zones, with the section taxonomy fixed before the first document is filed
✓Trial management essential documents, mapped to the zone and section each belongs in
✓Regulatory and ethics documents, including approvals, substantial amendments, and correspondence
✓Investigational product documents covering release, accountability, and destruction
✓Site and monitoring documents, with the sponsor and investigator file split made explicit
✓Completeness and quality-control tracker showing expected against present, by milestone
✓Archiving and retention plan, including format, location, and the retention period per jurisdiction

How to Use It

1Fix the zone and section taxonomy before filing anything; re-indexing a populated TMF is the expensive version of this step
2Map each essential document to a section and a responsible party, so nothing is expected from everyone and produced by no one
3Track expected against present by milestone, not by document count — a full TMF missing one approval is not complete
4Make the sponsor and investigator file split explicit, including documents required in both
5Quality-control contemporaneously; a TMF reviewed only at close-out cannot recover a document that was never created
6Define archiving format, location, and retention period per jurisdiction before the trial closes, not after
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 essential documents to be maintained in a trial master file that permits evaluation of the conduct of the trial and the quality of the data, kept current throughout. The EMA guideline on the content, management and archiving of the clinical trial master file frames structure, completeness, and archiving expectations for trials in the European Union. Which documents are essential for your trial, and where the sponsor and investigator files divide, are the sponsor's determinations and are recorded in this index.

MAPPED STANDARDS
ICH E6(R3)EMA TMF Guideline
Browse the standards catalog →