Spotlight On The TMF Reference Model

By Sharon Ames, Enterprise Program Director, NextDocs

• 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.