To develop a better trial master file (TMF) model for sites and sponsors, two clinical trial standards organizations have merged to implement greater collaboration and outreach with regulators and clinical research experts on the development of TMFs.

The Trial Master File Reference Model Group — formed in 2009 to create an adaptable TMF model for sponsors, sites and their staff — has joined forces with the Clinical Data Interchange Standards Consortium (CDISC) under the CDISC banner, a move that will open up new resources and collaborations for TMF development.

The latest iteration of the TMF model was released in November 2020; the group had gathered input from more than 400 contributors, including sponsors, CROs, vendors, consultants and regulatory agencies. Joining CDISC will give the group access to resources for publishing and distributing documentation and implementation guides, and provide dedicated staff to help manage events, education, membership and volunteers, among other benefits.