From Industry Recommendations To Reality – What's New In The TMF Reference Model 3.2.0

By Shah Ashraf, TMF Quality Team Manager, TransPerfect Life Sciences, Trial Interactive.

The beginning of November saw the launch of version 3.2.0 of the TMF Reference Model. The updates align with current regulatory guidance and industry best practices, making it easier to organize the TMF Reference Model to suit a company’s own processes.

As someone who has been heavily involved with the TMF Reference Model since 2010 and part of the sub-artifact working group tasked with the review for this new version, I am delighted to see over a year of hard work finally come to fruition. The revision of the sub-artifact column in particular has been an arduous task. I reviewed suggestions and recommendations for document types (both artifacts and sub- artifacts from multiple organizations), with many contributions lists in excess of over 2,890 items! On behalf of the group, I was personally able to combine and analyze all the lists provided into one comprehensive (huge!) list and remove any duplicates so the steering committee could commence review. This was completed in a methodical manner: zone by zone and ensuring each sub-artifact was relevant.