Version 3.2.0 of the TMF Reference Model Launched

The TMF Reference Model Steering Committee today announces that version 3.2.0 of the Trial Master File Reference Model is now available to download free of charge. The TMF Reference Model project originated in the DIA Document and Records Management Community in 2008. This latest release incorporates updates developed in response to 25 requests from industry received through June 2020. As a result, Version 3.2.0 of the Reference Model reflects updated regulatory guidance and current industry best practices – making it easier for organizations to configure the TMF Reference Model to their processes, and to further improve TMF quality, completeness, and timeliness.

In addition to expanding the scope and definition of artifacts and file types, TMF Reference Model v3.2.0:

  • adds a new column, “Recommended sub-artifacts,” an option to list company-specific records that an organization would expect to file under a given artifact; and
  • features a super-set of 612 customizable sub-artifacts to replace the previous “Sub-artifact” and “Alternate name” columns, providing greater flexibility to help ensure the TMF Reference Model is aligned with an organization’s SOPS and compliance needs.

What’s new in TMF Reference Model version 3.2.0?

  • One new artifact – 06.05.04 Non-IP Storage Documentation
  • Four changes to artifact names 
  • One filetype change – adding site level to Monitoring Plan
  • One milestone change 
  • 22 changes to Artifact Definition/Purpose, Milestones, Glossary, Model Overview and ICH Code
  • One new column, “Recommended sub-artifacts,” as described above

Note: “Alternate name” was retired and replaced by the new ”Recommended Sub-Artifacts” column. Individual companies may choose to retain this column for alternate names that may exist across divisions or with partners.

Organizations wishing to implement this latest version of the TMF Reference Model can find the latest complete Model, Release Notes, an updated Implementation Guide and a recording of the October 26 General Meeting where Version 3.2 was presented at Industry requests received since June are in the process of evaluation.

“This latest version of the TMF Reference Model builds on the hard work and incredible collaboration of so many people in our industry to standardize and simplify TMF management processes,” said Karen Roy, Chair of the TMF Reference Model Steering Committee. “In the 10 years since version 1.0 of the TMF Reference Model was launched, we have seen it embraced by organizations worldwide as a critical component supporting Trial Master File compliance and inspection-readiness. We fully expect version 3.2.0 to be a valuable contribution to this ongoing effort.”

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