Risk Proportionate TMF Oversight 

Moving beyond counting documents to demonstrating sponsor control

Completeness metrics and document counts may indicate progress, but they do not necessarily demonstrate sponsor control. As organizations operationalize ICH E6(R3), sponsors are increasingly expected to show how risks were identified, monitored, escalated, and addressed—not simply that documents exist.

This webinar explores how TMF oversight can move beyond document management to become evidence of sponsor control, connecting Critical to Quality (CTQ) factors, oversight activities, and TMF records into a defensible inspection narrative.

What You'll Learn

• Why completeness metrics fall short under ICH E6(R3)
• How CTQs connect to TMF evidence and oversight activities
• What “evidence of control” looks like during inspection review
• Where sponsor confidence varies across studies and why that matters
• How to better position TMF oversight to support inspection readiness