About the TMF Reference Model

The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. The Model can be adapted to an electronic or paper TMF, and does not endorse, nor require, any specific technology for application. DIA members and industry members are under no obligation to adopt the TMF reference model.


The TMF Reference Model is a valuable tool for:

• Biopharmaceutical sponsors of any size, both commercial and institutional, involved in clinical studies
• Clinical study team members, including trial and data management, clinical supplies, biostatistics, etc.
• Contract Research Organizations and vendors servicing TMFs, including technology providers
• TMF consultants
• Site staff, including investigators and coordinators
• Regulators who wish to overcome the challenges of different TMF terminology and file structures that create inefficiency and a higher degree of variability during sponsor audits

“DIA strives to serve as a knowledge resource for the dissemination of information to help professionals overcome some of their most challenging issues,” explains Paul Pomerantz, DIA Worldwide Executive Director. “With the support of an engaged group of industry leaders, our Document and Records Management SIAC has published a valuable resource for the clinical research community.”

It can be retrieved for free at http://www.diahome.org/en/HomePage/EDM+Corner.htm