Resources for Current Version of TMF Reference Model:
- TMF Reference Model v3.1.0, Released 10-SEP-2018, Excel Spreadsheet
- TMF Reference Model v3.1.0 Release Notes, Released 10-SEP-2018
- MindJet File for TMF-RM v3.0 (.mmap format – requires MindJet licence to open file or MindManager Viewer to view file)
- MindMap PDF File for TMF-RM v3.0 (.pdf format – requires Acrobat Reader and Adobe Flash)
- TMF Reference Model v3.1.0 Presentation – Overview of the Reference Model REVISED
- TMF Reference Model User Guide – Guide to the TMF Reference Model (revised 2018)
- 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):
- 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:
- TMF Reference Model User Guide: Introduction to the model, understanding its structure, and how to use it (v1.0 Approved 16-March-2018)
- TMF Reference Model Implementation Guidance: Provides a framework for implementing the model in your organization (v1.0 Approved 14-March-2018)
- 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)
The following are now incorporated into the TMF Reference Model:
- Milestones / Events: Suggested latest milestones or events by which each artifact should be filed (v1.1 Approved 31-January-2018)
- Date Conventions: Suggested date convention to use for each artifact (Approved 15-Feb-2017)
Annual TMF Reference Model Survey:
- 2015 TMF Survey Overview (PDF File)
- 2014 TMF Survey Overview (PDF File)
- 2013 TMF Survey Overview (PDF File)
- 2012 TMF Survey Overview (PDF File)
Miscellaneous Resources:
- Guideline on the Content, Management & Archiving of the Clinical TMF (06-Dec-2018) NEW
- MHRA Q&A Document from ExL TMF Summit, London, October 2018 REVISED 17-Dec-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)
- 2016 Project Team Roadmap
- DIA Framework for the Destruction of Paper Originals v2.0 (23-Jan-2019) NEW
- Presentation – Framework for Paper Destruction (May 2012)
- Process Map – Processes used in TMF Reference Model (July 2011)
Project Team All-Hands Meetings:
- January 9, 2017
- February 27, 2017
- April 24, 2017
- June 12, 2017
- September 11, 2017
- November 6, 2017
- January 22, 2018
- March 19, 2018
- May 14, 2018
- September 10, 2018
- November 12, 2018
- February 11, 2019 NEW
Meeting recordings (where available) can be accessed on our YouTube channel: click HERE NEW
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:
- TMF Reference Model v3.0, Released 16-JUN-2015, Superseded 10-SEP-2018
- TMF Reference Model v2.0, Released 25-JUN-2012, Superseded 16-JUN-2015
- TMF Reference Model v1.2, Released 02-DEC-2011, Superseded 25-JUN-2012
- TMF Reference Model v1.1, Released 11-FEB-2011, Superseded 02-DEC-2011
- TMF Reference Model v1.0, Released 04-JUN-2010, Superseded 11-FEB-2011