Risk Proportionate TMF Oversight 

Moving beyond counting documents to showing what matters under ICH E6(R3)  

Trial sponsors are navigating increasing trial complexity and evolving oversight expectations under ICH E6(R3). While document counts and completeness, quality, and timeliness metrics may indicate progress, they don’t always demonstrate whether risk was understood, monitored, and addressed. 

This webinar reframes TMF oversight from counting documents to demonstrating control—showing how CTQs, oversight activities, and TMF records come together to support inspection-ready sponsor oversight.

You’ll learn how to:

• Move beyond completeness metrics to show evidence of control through your TMF

• Understand how Critical to Quality (CTQ) factors should connect to oversight activities and TMF records

• Recognize where inspection confidence commonly varies across studies and why that matters

• Learn from real inspection experiences on how TMF oversight is assessed

• Identify where sponsors most often struggle — and where to focus attention to strengthen inspection readiness