Sponsors struggling with setting up trial master files (TMF) can turn to a recently upgraded reference tool that helps them build compliant and inspection-ready TMFs.

The new version of the TMF Reference Model, first developed in 2008 by the Drug Information Association (DIA) Document and Records Management Community, includes updated regulatory guidance and industry best practices, as well as industry change requests DIA has received through June 2020. 

Requests received since June are being evaluated by the TMF development committee. The open-source model can be downloaded, along with release notes and an updated implementation guide, from the TMF website: https://bit.ly/2IFkMoQ.