TMF Reference Model Review Imminent

As previously mentioned here, the formal review process to develop the next revision of the TMF Reference Model is about to kick-off. To support this process, the TMF Reference Model Steering Committee has released a slide deck to provide an overview of the process and what is needed to make the review successful.

The development of v3 of the Reference Model depends on contributions from as wide a variety of industry stakeholders as possible, including input from people with expertise in all areas, including the following:

  • sponsor TMF requirements
  • CRO TMF requirements
  • investigator site TMF requirements
  • device trials
  • diagnostics trials
  • drug trials

We are particularly keen to receive feedback from companies and organizations who have tried to implement the TMF Reference Model. A template will shortly be available for anyone to provide feedback but in addition we need:

  • volunteers to lead a small group of experts focussing on one of the Reference Model zones (Zone Lead)
  • volunteers to participate in reviewing the feedback for one of the Reference Model zones (Zone Member)
  • volunteers to participate in a technical team looking at the structure and format of the Reference Model spreadsheet itself (Technical Team Member)
  • volunteers to participate in a communications team looking at publicity, press releases, engaging with other groups etc (Communications Team)

If you would like to volunteer, please join the TMF Reference Model Team (if you are not already a member) and contact Karen Roy to put your name forward or send an email directly to    f e e d b a c k @ t m f r e f m o d e l . c o m

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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