- Industry accepted reference model for Trial Master File content
- Version 3.0 development starting imminently – get involved!
- Other initiatives – Usability, Metrics, Interoperability Quality
The Trial Master File Reference Model (TMF RM), a supported initiative of the Drug Information Association’s (DIA) Document and Records Management Community, is a collaborative reference for the contents of a TMF. First published in 2010, it is a single, unified interpretation of the regulations and best practices and was collaboratively developed through a volunteer effort that includes bio-pharmaceutical and device companies, contract research organizations (CROs), consultancies, technical vendors, industry groups, healthcare, academia and non-for-profit / NGO. Membership has quickly grown and by August 2014, over 350 members from over 200 companies. The group is managed by an elected Steering Committee, members detailed below.
The TMF Reference Model provides a reference for the industry and should not be considered mandatory, but rather an opportunity for harmonization across the industry in terms of content, naming and structure. The MHRA, EMA and FDA were invited to review, and their comments were incorporated. The TMF Reference Model can be adapted to either an electronic or paper TMF. It does not endorse, nor require, any specific technology for application.
The model can be downloaded from the DIA website. Although the DIA is fully supportive of the TMF RM, the work product of the group is in no way “owned”, governed, managed or endorsed by the DIA, hence DIA not being mentioned in its name.
Version 1 was published in 2010, version 1.1 (including Regulator feedback) in 2011 and version 2 in June 2012 which included additional details for Investigator Site Files, Investigator Initiated Studies, Process-based Metadata and Device Studies. The TMF RM volunteers are beginning the revision process to create version 3. Get involved in ‘Too Much Fun’ by joining the TMF RM group!.
Many of you will have heard of the OASIS eTMF standard for interoperability and will be wondering where this fits with the TMF RM. The answer is they should work together to be a standard for content and for interoperability, without impacting current implementations of the TMF RM. The TMF RM group seeks alignment between the two in order to advance the cause of interoperability for our industry; many TMF RM members provided feedback on the initial draft OASIS specification.
Over the coming months, several new TMF RM deliverables will be released, including:
- A Usability Guide, to help companies maximize the benefits of adopting the TMF RM
- A Metrics & Reporting Model, to help companies measure TMF completeness, timeliness, and quality using a common framework
- A Quality Control Process Model, to help companies improve quality throughout the lifecycle of the TMF
At the DIA EDM meetings in Washington (October) and Berlin (December), there will be dedicated sessions focussed on the EDM and eTMF Models, their usage, how they can be expanded, feedback & experience from users etc. New ideas often spring from these lively discussions – we hope to see you there!
Published by the TMF RM Steering Committee:
Sam Mowaswes, Daiichi Sankyo, Biopharma
Colleen Maude, GSK, Biopharma
Martin Thorley, Pfizer, Biopharma
Karin Schneider, Janssen, Biopharma
Tamika Jackson, Corementum, Consultant
Lisa Mulcahy, Mulcahy Consulting, Consultant
Fran Ross, Paragon, Consultant
Eldin Rammell (Secretary), Rammell Consulting, Consultant
Jamie Toth, Covance, CRO
Steve Scribner (Vice Chairman), EMC, Vendor
Paul Fenton, Montrium, Vendor
Sharon Ames, NextDocs, Vendor
Karen Roy (Chairman), Phlexglobal, Vendor / CRO
Todd Tullis, Veeva, Vendor
How to find out more:
Monthly calls (join our Yahoo! Group)