Risk-Proportionate TMF Oversight
Moving Beyond Counting Documents to Showing What Matters Under ICH E6(R3)
Free Webinar | Thursday, February 26 | 11 AM – 12:30 PM ET | Live and On-Demand Access
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, or addressed.
This webinar reframes TMF oversight from counting documents to demonstrating control—clarifying how CTQs, oversight activities, and TMF records come together to support inspection-ready sponsor oversight.
Designed for trial sponsors responsible for demonstrating oversight across studies, vendors, and systems.
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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 - Thursday, February 26
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
Learning from Real Inspection Experiences: How TMF Oversight is Being Evaluated by Regulatory Investigators
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
Liz Farrell, Director, Compliance and TMF Oversight, AGIOS PHARMACEUTICALS
Nick Hargaden, Senior Director, TMF, MERUS N.V.
Steph Viscomi, Director, Clinical Documentation and TMF, APELLIS PHARMACEUTICALS
- 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
12:15 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. No recordings. No 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
- Immediate access to the 2026 GCP Inspections Report, a practical resource translating regulatory data into actionable inspection readiness
- Access once registration is approved, included in confirmation email
- 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)
- Downloadable copy of the slides presented sent post webinar
2026 GCP Inspections Report – Available Upon Registration
A comprehensive resource that translates regulatory data into actionable inspection readiness.
- Built from recent GCP inspection patterns and sponsor-side oversight findings
- Highlights where TMF evidence commonly breaks down despite complete documentation
- Provides practical context to help sponsors benchmark inspection confidence and readiness
- Designed to support internal discussions on oversight focus and prioritization
Immediate access included with registration for qualified trial sponsors.
