Day 4 Session 3 - TMF Completeness Check, the GSK risk based approach to Inspection Readiness скачать в хорошем качестве

Day 4 Session 3 - TMF Completeness Check, the GSK risk based approach to Inspection Readiness

What happens when you move beyond periodic sampling and take a more proactive, risk-based approach to TMF oversight? In this session, GSK shares their journey toward adopting event-driven TMF completeness checks—and what it’s meant for inspection readiness, oversight, and operational efficiency. You’ll hear how GSK now conducts these checks in tandem with routine and risk-based TMF health reviews, the challenges they’ve faced, and the practical solutions they’ve implemented along the way. If you're rethinking your own TMF monitoring strategy, this session offers a valuable blueprint for making the shift. What you'll learn: Why GSK transitioned from periodic sampling to a risk-based, event-driven approach How TMF completeness checks are conducted alongside routine health oversight Challenges encountered with this new approach—and how they were addressed Practical insights to help you adopt or enhance risk-based TMF monitoring strategies CHAPTERS: 00:00 – Welcome & Housekeeping 02:19 – Meet the Speaker: Anne-Noëlle Charles of GSK 03:40 – Session Overview: TMF Process, Oversight & Risk-Based Monitoring 05:55 – Poll: Where Can Risk-Based Approaches Be Applied in TMF? 08:37 – TMF Oversight & Completeness Check at Study Level 11:18 – Going Beyond Completeness, Timeliness, and Quality 13:52 – Linking TMF Metrics to Study Risk 17:00 – From Periodic Review to Risk-Based TMF Completeness Check 20:04 – TMF Completeness Check: Process Overview 22:45 – Scope Agreement: The Most Critical Step 25:12 – Defining Proportionate, Risk-Based Checks 27:45 – Personalized TMF Reviews: Moving Beyond Random Sampling 30:06 – Interactive Discussion: Benefits of GSK’s Approach 31:15 – Key Implementation Challenges & Solutions 34:58 – Live Q&A: Documenting Decisions, Measuring Readiness & Functional Engagement 40:35 – Final Q&A: TMF Plans & SOP Integration 41:19 – Wrap-Up & What’s Next