Day 2 Session 3 - Site Seeing Tour Understanding ISF Reference Model v1 Essentials скачать в хорошем качестве

Day 2 Session 3 - Site Seeing Tour Understanding ISF Reference Model v1 Essentials

Standardization is coming to the Investigator Site File—and it’s about time. In this session, two key contributors to the ISF Reference Model initiative will take you behind the scenes of this pivotal project, designed to bring greater consistency, clarity, and compliance to site-level documentation across the industry. You’ll hear about the progress made so far, the challenges being tackled, and what’s next on the roadmap. From aligning global stakeholders to planning for practical implementation, this session offers a first look at how the ISF Reference Model could transform clinical trial operations at the site level. What you'll learn: What the ISF Reference Model is and why it matters Progress to date and key milestones in the model’s development Common challenges in standardizing site-level documentation How the ISF model aligns with broader industry initiatives like the TMF Reference Model CHAPTERS 00:00 Intro 01:36 Session introduction 02:26 Speakers introduction 04:14 Overview 06:43 Why is the ISF RM needed? 08:51 Timeline 12:00 Challenges 14:27 ISF RM Release v1 16:45 Ongoing & Future Activities 21:25 Q&A 42:11 Next session introduction