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TMF Reference Model Continues Momentum with Release of V3.0

Aug 12, 2015 | Todd Tullis

Version 3.0 of TMF Reference Model was published on June 16, 2015, marking an important milestone in the evolution of this popular industry initiative. As the “Controller” (Project Manager) for TMF RM v3.0, I had a unique perspective on this industrywide collaborative effort. For almost eight months (October 2014-June 2015), more than 100 volunteers contributed or reviewed material and worked diligently to further this shared asset.

Use of the TMF Reference Model has grown to the point that it has become a near-standard reference for clinical development organizations worldwide. The model fills a significant gap in regulations & guidance – ICH GCP does not provide a comprehensive list of contents for a trial master file.

The model is organized into “Zones”, “Sections”, and “Artifacts” — a common misconception regarding the model is that the artifacts are intended to be specific records. While some artifacts are specific (e.g., FDA 1572), most artifacts are, by design, “buckets” into which many kinds of records would be filed (e.g., IP Shipment Documentation). One of the most important changes in the new version is the addition of a column for “Sub-artifact Examples.” Adding this new column should help drive understanding of this key concept by providing companies with a clear place to document the mapping of their company specific records to the TMF Reference Model. In version 3.0, example sub-artifacts are also provided with the intent that organizations adopting the reference model will map and overwrite those examples with the specific names of the records called for in the organization’s’ SOPs. Such a mapping exercise is step 1 for any organization that wishes to adopt the model.

The project team was very careful with content changes, thus the volume of such changes was kept fairly low. A few highlights:

  • In Zone 01, the “Trial Committee” section was revised to allow flexible categorization of records generated by any study committee – previously the artifacts in this section referred to one specific type of committee (data adjudication).
  • New & updated artifacts to clarify qualification, regulatory responsibility agreements, and oversight records for sponsors working with third parties.
  • In Zone 02, the first section was revised to be called “Product and Trial Information” to better organize the kinds of product records required in a TMF – often such records are reused across many studies, and the newly named section and added artifacts allow for clearer designation of those kinds of records.
  • Wherever possible, artifact numbers were maintained – and where not possible, newly added artifacts received new numbers. While the “Unique ID” is the intended non-changeable “number” for a given artifact, the team realized that many users of the model rely on the “01.02.04” numbers to identify specific artifacts, and we felt maintaining those across versions was a worthy goal.

    • Several ancillary deliverables were developed to coincide with the publication of the new model version. These include:

  • An XML-based eTMF Exchange Mechanism, to better support transfers of eTMF content between systems and organizations.
  • A “Mind Map” representation of the TMF Reference Model, to provide a more visual way to peruse and understand the model.
  • A TMF Reference Model User Guide, to provide additional guidance for organizations implementing or using the model.

    • These deliverables are and/or will be made available to the public via the TMF Reference Model website.

    The consensus I have heard from Veeva customers is an eagerness to begin using v3.0 of the model. As a volunteer who has worked on the TMF Reference Model for nearly four years, this is a great sign – many of these companies used their eTMF implementations to introduce the model to their organization, and using it has simplified communication with internal and external team members. With more volunteer power than ever behind the model, I look forward to hearing the additional benefits that version 3.0 will bring our customers and the industry as a whole.

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