TMF Reference Model: Adopt or Adapt?

April 15, 2015

  • eTMF Guidelines

We all know that the TMF Reference Model as been a tremendous asset to organizations, allowing them to define their TMFs in a way that promotes completeness, interoperability with other organizations, and increased ease of use for Health Authority inspectors. Recently I’ve participated in some discussions around whether the model should be used out of the box or adapted to the needs of a specific organization. In my experience, most organizations with the exception of the smallest ones make some level of change to the model. Last year’s TMF Reference Model Survey #4 supports this observation. When asked about their use of the model, only 27% of respondents answered that they used the model “as is”:

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The reference model survey also asked those who change the model what they change, with these results:

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Does changing the reference model add value? After working with our clients, participating in discussions at conferences, and monitoring discussion threads on LinkedIn, I would say a qualified “Yes”. Some key points to consider are:

  • Does the reference model provide a sufficient level of granularity for its intended use in your organization? Several of my clients have taken existing artifacts and broken them down to a more granular level. They believe this encourages correct filing, improves ability to judge completeness of the TMF, and improves the ability to find specific documents.
  • Does the reference model cover all document types you need to collect? The reference model is most mature when used for trials involving drugs and biologics in the US and Europe. It has always been challenging to adequately represent medical devices and combination products in the model as those user communities have not participated as extensively in the working groups. (There is an ongoing med device working group at this time.) Likewise, requirements outside of the US and EU, or for specialized types of trials or products, may not be as fully represented.
  • Do you want to include documents that are not required by Health Authorities? Some organizations want to include administrative, reporting or partnering documents not needed in the official TMF but contributing to other business goals.

As additional point – the reference model, although highly useful, is not perfect. Feedback from the user community is periodically solicited, and changes are made to the model based on the experiences of the user base in fitting it into their organizations. Every time the model is updated, artifacts are added, renamed, and clarified. In fact, this process is going on right now – see the TMF Reference Model Version 3.0 Press Release for details.