Day 2 Session 2 - Way Past Paper Charting the Digital Future of the CDISC TMF Reference Model скачать в хорошем качестве

Day 2 Session 2 - Way Past Paper Charting the Digital Future of the CDISC TMF Reference Model

Big changes are on the horizon for the TMF Reference Model. In this forward-looking session, we’ll explore what’s coming in version 4—and what lies beyond. Whether you're a long-time user or just getting familiar with the model, this is your chance to understand where the industry is headed and how you can prepare. Join us for a deep dive into the next three years of planned initiatives, including the shift toward record types, expanded metadata standards, alignment with ICH E6(R3), and the introduction of process-based models. Get a clear view of the evolving vision and how these developments will impact your TMF strategy. What you'll learn: Key updates coming in TMF Reference Model v4 and beyond How the model is aligning with ICH E6(R3) What to expect from new metadata and process-based model initiatives The long-term vision for TMF standardization and how to stay ahead of the curve CHAPTERS 00:00 Intro 03:25 Session introduction 04:00 A Vision for the future 04:52 Digital First 06:03 Harmonization 07:21 Governed Standards 09:22 Community Driven 10:23 Interoperability & Integration 11:12 Data & Process Driven 12:16 Regulatory Recognition 13:40 CDISC TM RM Roadmap 2025-2028 14:41 Core Standard Development 19:18 Digital TMF Metadata Standard - Interoperability 23:06 Ancillary Standards and Mappings 29:01 TMF RM Standard Management Tools 30:38 Training, Guidance and Frameworks 33:16 Q&A 45:15 Closing statement and next session introduction