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:
- September 13, 2021 – Slide Deck YouTube Recording NEW
- 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
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
Prior Versions of the TMF Reference Model:
See Resources Archive page