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.
May 9, 2022 – Slide Deck YouTube Recording NEW
March 14, 2022 – Slide Deck YouTube Recording
January 24, 2022 – Slide Deck YouTube Recording
December 13, 2021 – Slide Deck YouTube Recording
September 13, 2021 – Slide Deck YouTube Recording
July 19, 2021 – Slide Deck YouTube Recording
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
TMF Reference Model Training, Part 1: History and Current Status
TMF Reference Model Training, Part 2: Definition, Application, Maintenance, Implementation
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 the 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
Recording: Meeting of TMF-EMS Change Control Board 28-Jul-2022 NEW
Recording: Meeting of TMF-EMS Change Control Board 31-May-2022
eTMF-EMS Specification v1.0.2 Published 21-Jan-2022
eTMF-EMS Release Notes r22.1 Published 21-Jan-2022
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)
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)
2015 TMF Survey Overview (PDF File)
TMF Reference Model Initiative Charter (current version) REVISED
Webinar – EU Clinical Trial Regulation and its Impact on TMF Content & Process NEW
Position Paper on CDISC Affiliation
Applicability of 21CFR11 to Third Parties – FDA Q&A (19-JUL-2021)
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 Version Control Policy
Steering Committee Charter (27-NOV-2017)
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
See Resources Archive page