TRIAL MASTER FILE (TMF) PLAN - Approvals

Aug 31, 2026

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Trial Master File (TMF) Plan template defining how trial records are set up, managed, stored, and controlled during and after study conduct. It specifies responsibilities for sponsor and other involved parties, including oversight and access arrangements, recordkeeping standards, and secure handling requirements compliant with ICH-GCP and local regulations. The plan also covers TMF maintenance, review processes, training, transfers, record disposition, and references applicable SOPs, ensuring consistent adherence across the study team.

LanguageEnglish

CategoryForms

FormatDOCX

Pages23

Reading Time8 min

AccessFree to download

Approvals

Document Version History

Definitions and Abbreviations

Introduction

TMF Oversight & Access Arrangements

RACI Matrix

Access arrangements

TMF Maintenance delegated to a CRO/Vendor

For Inspections/Audits

TMF Content

TMF Format, Structure/Content Map/Specifications

Authoritative Sources

Originals, Wet Inks, and Raised Seals

Relevant Correspondence

Unblinded Records

Translations

Record and TMF Disposition

Destruction

Retention

Archiving

Sponsor TMF

Investigator TMF

Legal Hold

Applicable SOPs

TMF Training

Conducting TMF Reviews

TMF Review Plan

TMF Review Documentation

Transfers of TMF

Appendix

[Instructions for use: Green text is instructional guidance on how to complete the TMF Plan and must be removed prior to finalization. Blue bold/italicized text is where expected content should be completed. This document has a page break for every section, which you may choose to remove to make the document less pages. After making adjustments to this document, and removing green text, you will need to Update the Table of Contents table on page 2 so that the page numbers are accurate. The entire plan is entered with Arial Narrow font. Tables have black headings with white font and are designed to split across pages. OVERVIEW PAGE to be completed by initiator of the TMF Plan and fill in as much detail as possible. Change Headers/Footers to match your sponsor information and following your sponsor practices/formats.] TRIAL MASTER FILE (TMF) PLAN [ENTER SPONSOR NAME] TOC \h \u \z HYPERLINK \l "_Toc506893372" 1 Approvals PAGEREF _Toc506893372 \h 3 HYPERLINK \l "_Toc506893373" 2 Document Version History PAGEREF _Toc506893373 \h 4 HYPERLINK \l "_Toc506893374" 3 Definitions and Abbreviations PAGEREF _Toc506893374 \h 5 HYPERLINK \l "_Toc506893375" 4 Introduction PAGEREF _Toc506893375 \h 6 HYPERLINK \l "_Toc506893376" 5 TMF Oversight & Access Arrangements PAGEREF _Toc506893376 \h 8 HYPERLINK \l "_Toc506893377" 5.1 RACI Matrix PAGEREF _Toc506893377 \h 8 HYPERLINK \l "_Toc506893378" 5.2 Access arrangements PAGEREF _Toc506893378 \h 9 HYPERLINK \l "_Toc506893379" 5.3 TMF Maintenance delegated to a CRO/Vendor PAGEREF _Toc506893379 \h 9 HYPERLINK \l "_Toc506893380" 5.4 For Inspections/Audits PAGEREF _Toc506893380 \h 10 HYPERLINK \l "_Toc506893381" 6 TMF Content PAGEREF _Toc506893381 \h 11 HYPERLINK \l "_Toc506893382" 6.1 TMF Format, Structure/Content Map/Specifications PAGEREF _Toc506893382 \h 11 HYPERLINK \l "_Toc506893383" 6.2 Authoritative Sources PAGEREF _Toc506893383 \h 11 HYPERLINK \l "_Toc506893384" 6.2.1 Originals, Wet Inks, and Raised Seals PAGEREF _Toc506893384 \h 12 HYPERLINK \l "_Toc506893385" 6.2.2 Relevant Correspondence PAGEREF _Toc506893385 \h 12 HYPERLINK \l "_Toc506893386" 6.2.3 Unblinded Records PAGEREF _Toc506893386 \h 13 HYPERLINK \l "_Toc506893387" 6.2.4 Translations PAGEREF _Toc506893387 \h 13 HYPERLINK \l "_Toc506893388" 7 Record and TMF Disposition PAGEREF _Toc506893388 \h 14 HYPERLINK \l "_Toc506893389" 7.1 Destruction PAGEREF _Toc506893389 \h 14 HYPERLINK \l "_Toc506893390" 7.2 Retention PAGEREF _Toc506893390 \h 14 HYPERLINK \l "_Toc506893391" 7.3 Archiving PAGEREF _Toc506893391 \h 14 HYPERLINK \l "_Toc506893392" 7.3.1 Sponsor TMF PAGEREF _Toc506893392 \h 14 HYPERLINK \l "_Toc506893393" 7.3.2 Investigator TMF PAGEREF _Toc506893393 \h 15 HYPERLINK \l "_Toc506893394" 7.4 Legal Hold PAGEREF _Toc506893394 \h 15 HYPERLINK \l "_Toc506893395" 8 Applicable SOPs PAGEREF _Toc506893395 \h 16 HYPERLINK \l "_Toc506893396" 9 TMF Training PAGEREF _Toc506893396 \h 17 HYPERLINK \l "_Toc506893397" 10 Conducting TMF Reviews PAGEREF _Toc506893397 \h 18 HYPERLINK \l "_Toc506893398" 10.1 TMF Review Plan PAGEREF _Toc506893398 \h 18 HYPERLINK \l "_Toc506893399" 10.2 TMF Review Documentation PAGEREF _Toc506893399 \h 18 HYPERLINK \l "_Toc506893400" 11 Transfers of TMF PAGEREF _Toc506893400 \h 19 HYPERLINK \l "_Toc506893401" 12 Appendix PAGEREF _Toc506893401 \h 20 Approvals [Approval and form of the approval is at the discretion of the sponsor authoring the TMF plan. Consideration should be given as to whom on the project should at a minimum agree to the terms of the TMF Plan. Example is provided below and can be removed if not needed or replaced by a simple approval statement. If electronic signatures or approvals are in place then the below could simply state that.] Document Version History

FAQs

What is the purpose and scope of the TMF Plan?

The TMF Plan outlines the process and procedures for managing and storing trial records to ensure high-quality TMF. It covers responsibilities for the sponsor and other involved parties and includes archiving and destruction processes, with guidance to align study team expectations.

Who is responsible for TMF setup and maintenance?

The plan states that TMF setup and maintenance involve responsible parties described in a table. It also allows inclusion of vendor/CRO responsibilities when the TMF is managed externally.

How does the plan ensure TMF access is controlled during and after the trial?

The document requires secure management of TMF records so access is controlled at all times. It includes oversight and access arrangement sections and procedures for audits/inspections and TMF review activities.

Aug 31, 2026

Upload by Aditya