Version 3.2.0 of the TMF Reference Model Launched
The TMF Reference Model Steering Committee announced that version 3.2.0 of the Trial Master File Reference Model is now available to download free of charge. This latest release incorporates updates developed in response to 25 requests from industry received through June 2020. As a result, Version 3.2.0 of the Reference Model reflects updated regulatory guidance and current industry best practices.
“This latest version of the TMF Reference Model builds on the hard work and incredible collaboration of so many people in our industry to standardize and simplify TMF management processes,” said Karen Roy, Chair of the TMF Reference Model Steering Committee. “In the 10 years since version 1.0 of the TMF Reference Model was launched, we have seen it embraced by organizations worldwide as a critical component supporting Trial Master File compliance and inspection-readiness. We fully expect version 3.2.0 to be a valuable contribution to this ongoing effort.”
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Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
