Risk-Proportionate TMF Oversight
Moving Beyond Counting Documents to Demonstrating Sponsor Control
Free Webinar | Wednesday, August 19 | 11 AM – 12:30 PM ET | Live and On-Demand Access
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.
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What to Expect
This 90-minute webinar combines expert insight with real inspection experience. The session opens with an industry snapshot based on participant registration data, followed by a focused presentation on risk-proportionate TMF oversight under ICH E6(R3).
The second half of the session features a panel of trial sponsors grounded in real inspection experience, followed by live Q&A. Full session details are outlined in the agenda below.
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
Who Should Attend
This webinar is designed exclusively for trial sponsors responsible for TMF oversight and inspection readiness, including:
- Clinical Operations professionals
- Quality and GCP professionals
- TMF and Clinical Documentation leads
- Study and Trial Management teams
- Sponsor teams overseeing CROs and service providers
Agenda - Wednesday, August 19
11:00 AM ET
INTRODUCTION
Where Trial Sponsors Are Today: Insights from Registration Data
- Review participant demographics, including experience levels and company size
- See how peers answered key TMF oversight questions
- Understand industry patterns related to CTQs, TMF use, and inspection confidence
- Set context for the discussion that follows
11:05 AM ET
PRESENTATION
Risk Proportionate TMF Oversight: Moving Beyond Counting Documents
Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
- Explain why completeness metrics and document counts fall short under ICH E6(R3)
- Clarify how Critical to Quality (CTQ) factors redefine what TMF oversight needs to demonstrate
- Introduce the continuous risk loop: identifying CTQs, monitoring data, detecting signals, and documenting oversight
- Show how the TMF serves as evidence of control, not just a record repository
- Frame what inspectors look for when assessing sponsor oversight today
11:35 AM ET
PANEL DISCUSSION
Demonstrating Sponsor Control in Practice: Lessons from TMF Oversight and Inspection Readiness
Experts share firsthand experiences responding to regulatory requests to demonstrate TMF oversight—what approaches worked well, what challenges they faced, and what they’d do differently next time.
Moderator
Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
Panelists
TBD
- Hear firsthand inspection experiences from sponsor and quality leaders
- Understand how TMF oversight is assessed during inspections
- Learn what types of TMF evidence helped explain decisions and actions
- Discuss where completeness metrics fell short
- Take away practical insights to strengthen inspection confidence
12:20 PM ET
LIVE AND UNFILTERED: SPEAKER Q&A SESSION
(Not Recorded—Must Attend Live)
Get face-to-face (virtually) with the previous speakers in an exclusive, live-only Q&A. This is your chance to ask the real questions—the ones you’ve been dying to ask but never see on a slide.
No slides, recordings or judgment. Just candid conversation, behind-the-scenes insights, and the space to dig into what really matters.
12:30 PM ET
WEBINAR ENDS — On-Demand Version Available for 30 Days
What Registration Includes
- Live participation in the 90-minute live webinar on Risk-Proportionate TMF Oversight
- Includes expert presentation, moderated panel discussion, and live Q&A
- Insight from anonymized participant data showing how sponsors compare across confidence, experience, and TMF oversight approaches
- 30-day access to the on-demand recording (presentation and panel discussion; live Q&A excluded)
- TMF Oversight Prioritization Tool sent post webinar
- Downloadable copy of the slides presented sent post webinar
TMF Oversight Prioritization Tool – Included with Qualified Registration
A practical guide for translating risk-proportionate oversight principles into actionable sponsor oversight strategies.
- Assess study-specific factors that influence oversight priorities
- Determine where increased sponsor attention may provide the greatest value
- Align oversight activities with Critical to Quality (CTQ) factors and study risks
- Focus on demonstrating sponsor control, not simply document completeness
- Create a more targeted, scalable approach to TMF oversight
How Just in Time GCP Can Help
Just in Time GCP helps trial sponsors translate TMF oversight efforts into inspection-ready evidence of sponsor control through:
- Risk-proportionate TMF oversight assessments
- Cross-functional ICH E6(R3) alignment workshops
- Sponsor oversight process optimization
- CTQ- and risk-based TMF review frameworks
- Inspection readiness preparation focused on oversight activities and decision-making evidence
- Operational harmonization across Clinical Operations, Quality, TMF, and CRO partners
