Day 2 Session 1 - Beyond the PDF The Digital Convergence of DDF and TMF скачать в хорошем качестве

Day 2 Session 1 - Beyond the PDF The Digital Convergence of DDF and TMF

The future of clinical trials is digital—and that includes the TMF. In this session, we’ll explore how the CDISC Unified Study Definition Model (USDM) is paving the way for digital protocols, and what that means for the Trial Master File. As digital data flow (DDF) becomes more of a reality, aligning TMF standards with this evolution is key. Through real-world examples, we’ll look at how the TMF Reference Model can connect with USDM to improve efficiency, traceability, and interoperability. Join us to better understand how this alignment supports a more streamlined, digital-first clinical trial ecosystem. What you'll learn: What CDISC’s USDM is and where it stands today How the digital protocol movement impacts TMF management Ways the TMF Reference Model can align with and benefit from USDM CHAPTERS 00:00 TMF Week introduction 06:25 Session and speakers introduction 09:40 What is ICH M11? 11:30 What is USDM? 12:56 Session Agenda 13:34 DDF and USDM - A primer and where we are today 16:17 The USDM Standard 19:37 M11 & USDM 22:32 USDM 24:21 ICH M11 Updated Draft Released 25:52 Structured v Unstructured 27:51 ICH M11 & USDM 30:09 Visualizing the USDM 32:42 Q&A 43:21 Closing words & next session introduction