TMF Reference Model:

• TMF Reference Model V3.2.1, Released 01-Mar-2021, Excel spreadsheet
• TMF Reference Model V3.2.1 Release Notes, Released 01-Mar-2021
• TMF Reference Model V3.2.0, Released 02-Nov-2020, Excel spreadsheet
• TMF Reference Model V3.2.0 Release Notes,  Released 02-Nov-2020 (see revised Implementation Guide below)
• TMF Reference Model v3.1.0, Released 10-SEP-2018, Excel Spreadsheet
• TMF Reference Model v3.1.0 Release Notes, Released 10-SEP-2018

Please note: Older resources can be found on our Resources Archive page.

Project Team All-Hands Meetings:

• July 19, 2021 – Slide Deck   YouTube Recording  NEW
• June 7, 2021 – Slide Deck   YouTube Recording
• April 19, 2021 – Slide Deck    YouTube Recording     
• March 1, 2021 – Slide Deck   YouTube Recording     
• January 11, 2021 – Slide Deck     YouTube Recording
• October 26, 2020 – Slide Deck    YouTube Recording
• September 21, 2020 – Slide Deck    YouTube Recording
•  July 27, 2020 – Slide Deck    YouTube Recording
• June 22, 2020 – Slide Deck    YouTube Recording
• May 11, 2020 – Slide Deck     YouTube Recording
• March 30, 2020 – Slide Deck      YouTube Recording
• February 3, 2020
• November 18, 2019
• September 23, 2019
• June 3, 2019
• April 1, 2019
• February 11, 2019

Meeting recordings (where available) can be accessed on our YouTube channel: click HERE

Resources for Current Version of Model:

• TMF Reference Model Implementation Guidance: Provides a framework for implementing the model in your organization (v2.0 Approved 02-November-2020)
• TMF Reference Model User Guide – Guide to the TMF Reference Model (v2 Approved 18-Nov-2020) REVISED
• TMF Reference Model v3.1.0 Presentation – Overview of the Reference Model  REVISED
• TMF Reference Model Process Maps: Used in development of Reference Model to align TMF artifacts to trial processes
• The Evolution of the TMF Reference Model v3.0: Recording of webinar delivered in July 2015

eTMF Exchange Mechanism Standard (eTMF-EMS):

• Recording: Exchange mechanism Standard Survey Results
• eTMF-EMS Specification v1.0.1 Released 25-OCT-2019
• eTMF-EMS Release Notes r19.3.2 25-OCT-2019
• eTMF-EMS Release Notes r19.1.5
• eTMF-EMS Specification v1.0, Released 14-JUN-2018
• XML Exchange Structure (hosted on GitHub)
• eTMF-EMS Launch Presentation at DIA Global 22-JUN-2018 (PowerPoint)

TMF Tools:

• Email Communications in the TMF: Webinar Slides   YouTube Recording (webinar held 15-Jan-2021)
• Responses to Questions: Email Communications in the TMF
• Real-World Studies Document Index Provides a proposed Document Index for use on real-world studies, based on the TMF Reference Model for clinical trials (v1.0 Approved 29-July-2020)
• Industry Guidance: Email Communications Guidance from the TMF Reference Model Project on the management of email communications in clinical studies (v1.0 Approved 29-July-2020)
• TMF Plan Template: Suggested structure and outline for a Trial Master File Plan  (v1.0 Approved 23-February 2018)
• TMF Plan Template Feedback: Click on LINK to provide feedback on the TMF Plan
• Date Conventions Guidance: Guidance notes to be used with Date Conventions columns (Approved 15-Feb-2017)
• TMF Quality Control: Toolkit to help prepare a TMF quality control programme (Approved 12-Oct-2016)
• TMF Quality Control Presentation: Powerpoint slides presented to group meeting November 7, 2016
• Inspection Readiness RACI: RACI Toolkit to help prepare TMF for regulatory inspections (Approved 09-Nov-2016)
• Inspection Readiness Presentation: Powerpoint slides presented to group meeting January 9, 2017
• eTMF Selection – Request for Proposal Template (co-authored by Scientific Archivists Group, TMF Reference Model and Pocket EDMS, March 2017
• Inspection FAQs: Common inspection questions with answers, and regulatory resource list (Approved 15-Mar-2017)

• Metrics 101 – How to Implement a TMF Metrics Program (PDF File)
• Metrics 101 – How to Implement a TMF Metrics Program (PPT File)
• Metrics Definitions – Recommended Metrics for your TMF Metrics Program (XLS File)

Annual TMF Reference Model Survey:

• 2015 TMF Survey Overview (PDF File)

Miscellaneous Resources:

• Applicability of 21CFR11 to Third Parties – FDA Q&A (19-JUL-2021)  NEW
• Future-proofing the TMF Reference Model: Discussion during General Meeting (19-Apr-2021)
• Guideline on the Content, Management & Archiving of the Clinical TMF (06-Dec-2018)
• MHRA Q&A Document from ExL TMF Summit, London, October 2018
• Duke Clinical Research Institute Resources External resource – Not a project deliverable(14-Nov-2018)
• NIH Resources for Clinical Research  External resource – Not a project deliverable (01-Aug-2018)
• Presentation to ICH M2 Expert Working Group (10-Apr-2018)
• TMF Exchange Mechanism Status Summary
• 2017 MHRA TMF Focus Day Summary
• Steering Committee Members
• TMF Reference Model Project Charter (current version)
• TMF Reference Model Version Control Policy  
• Steering Committee Charter (27-NOV-2017)

Published Articles:

• TMF Reference Model Standard = Process Efficiency (published Applied Clinical Trials, May 2014)
• TMF Reference Model Presentation: Overview of the TMF Reference Model, Published August 2012