TMF Reference Model:

Project Team All-Hands Meetings:

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

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

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)

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