TMF Standard Model V1 Webinar
TMF Standard Model V1 - Rethinking the Evidence of GCP Compliance
How the New TMF Standard Supports ICH E6(R3) Compliance, Sponsor Oversight, and Inspection Readiness
Free Webinar | Tuesday, November 3, 2026 | 11 AM - 12:30 PM ET | Live and On-Demand Access
This Is Bigger Than the TMF.
TMF Standard Model V1 represents far more than a new approach to organizing clinical trial records. It signals a significant industry shift toward a more consistent, evidence-driven approach to GCP compliance.
By connecting clinical trial evidence to ICH E6(R3), V1 provides a new foundation for evaluating the processes that generate evidence of compliance, strengthening sponsor oversight, and improving inspection readiness.
The TMF Standard Model V1 Draft Is Here!
Help Shape the Future of Clinical Trial Evidence
As of Monday, October 19, the CDISC TMF Standard Model V1 draft is open for community review. Explore the draft and submit your comments by November 20, 2026.
With the V1 draft now available for community review, what should your organization be paying attention to?
With community feedback due November 20, our November 3 webinar offers a timely opportunity to explore the implications of V1, hear directly from the experts developing it, and consider the feedback your organization may want to contribute.
Why Attend?
- Hear directly from the experts helping develop V1 to understand its implications beyond the TMF, identify opportunities for your organization, and learn what to evaluate now.
- **Exclusive White Paper Included:** *TMF Standard Model V1: A New Blueprint for Sponsor Oversight*, authored by Donna Dorozinsky.
- **Live-Only Expert Q&A:** Ask questions while the V1 draft is open for community review.
Page Sections
What to Expect
Join Donna Dorozinsky, Founder & CEO of Just in Time GCP and Project Leader for CDISC TMF Standard Model V1, and Aaron Grant, Head of Innovation at Just in Time GCP and contributor to V1’s technical development, for an inside look at the thinking behind the new Standard, the latest developments, and what they mean for clinical research.
Drawing on their direct involvement in V1 development, Donna will explore the broader implications for GCP compliance, sponsor oversight, and inspection readiness, while Aaron will explain how V1’s approach to metadata can make clinical trial evidence more accessible, consistent, and useful.
What You'll Learn
- Why V1 matters: What prompted the evolution from the TMF Reference Model to a formal Standard, and what makes the new approach fundamentally different.
- Connecting evidence to ICH E6(R3): How V1’s mapping to modern GCP requirements could change the way organizations understand and demonstrate compliance.
- The opportunities for stronger oversight and inspection readiness: How the Standard could help organizations gain greater visibility into clinical trial evidence across systems, functions, and service providers.
- Making clinical trial evidence more accessible: How V1’s approach to metadata and attributes can improve record retrieval, interoperability, and the exchange of evidence across systems and organizations.
- Preparing for what’s ahead: What organizations can begin evaluating today to understand the implications of V1, identify potential gaps, and position themselves to take advantage of the opportunities ahead.
- What’s next: The latest development milestones, outstanding considerations, and what to expect as V1 moves toward finalization.
Whether you’re new to TMF Standard Model V1 or have been following its development, this webinar will provide the context, insights, and practical direction to help you understand its significance and begin preparing your organization for what’s ahead.
Who Should Attend
This webinar is designed for clinical research professionals across sponsors, CROs, service providers, and technology organizations, including those working in:
- Clinical Operations & Development
- Clinical Quality & GCP Compliance
- TMF Management & Oversight
- Regulatory Affairs & Inspection Readiness
- Clinical Data Management
- eClinical Systems & Technology
- Risk Management & Vendor Oversight
- Clinical Research Leadership
Whether you’re directly responsible for TMF management or involved in the processes, systems, and oversight activities that generate evidence of GCP compliance, this webinar will help you understand why V1 matters to your role and your organization.
No prior knowledge of TMF Standard Model V1 is required.
Agenda - Tuesday, November 3
11:00 AM ET
WELCOME AND INDUSTRY INSIGHTS
What You Told Us: Insights from Webinar Registration Data
Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
Kristen Hunter, Marketing Lead, JUST IN TIME GCP
- Who’s joining us? A look at attendees by organization type, functional area, and experience.
- How familiar is the industry with V1, and how far along are organizations in preparing?
- What do attendees see as the single greatest potential benefit of V1?
- What challenges are organizations anticipating as they consider the transition?
11:10 AM ET
PRESENTATION
TMF Standard Model V1: What's Changing, Why It Matters & How to Prepare
Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
- Understand why the TMF Reference Model is evolving into a formal Standard and what makes V1 fundamentally different.
- Explore the shift from records management to evidence control and what it means for clinical research.
- Discover how V1’s mapping to ICH E6(R3) can support GCP compliance.
- Examine how the new Standard can strengthen sponsor oversight, improve visibility into clinical trial evidence, and support inspection readiness.
- Identify opportunities to leverage V1’s standardized structure and metadata to improve consistency, interoperability, and efficiency.
- Learn what steps organizations can take now to prepare for the transition and maximize the potential benefits of V1.
- Get an update on the latest developments, upcoming milestones, and what’s next for the Standard.
12:00 PM ET
PRESENTATION
Making Clinical Trial Evidence More Accessible: The Role of Metadata in V1
Aaron Grant, Head of Innovation, JUST IN TIME GCP
- Discover how V1’s approach to metadata can make clinical trial evidence easier to find, understand, and exchange across systems and organizations.
- Understand why distinguishing Record Type Attributes from Record Instance Metadata is important for consistent evidence management.
- Explore how Standard and Provisional Metadata establish a foundation for greater interoperability, efficiency, and future automation.
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, 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 TMF Standard Model V1
- Includes expert presentations and live Q&A
- Insight from anonymized participant data comparing confidence, experience, and approaches
- 30-day access to the on-demand recording (opening and presentations; live Q&A excluded)
- Exclusive White Paper on TMF Standard Model V1: A New Blueprint for Sponsor Oversight, sent following the webinar
- Presentation Slides sent following the webinar
Exclusive White Paper Included for Participants
TMF Standard Model V1: A New Blueprint for Sponsor Oversight
A thought-provoking exploration of how TMF Standard Model V1 can help trial sponsors evaluate the processes behind oversight and strengthen how they demonstrate GCP compliance.
Written by Donna Dorozinsky, Project Leader for TMF Standard Model V1, who is helping shape the future of digital clinical trial evidence and GCP compliance.
The connection between TMF Standard Model V1 and ICH E6(R3)
Why TMF completeness alone doesn’t demonstrate effective oversight
How V1 creates new opportunities to evaluate oversight processes
Identifying gaps between regulatory expectations and evidence of compliance
Practical considerations for strengthening sponsor oversight
How Just in Time GCP Can Help
Just in Time GCP helps clinical trial sponsors leverage TMF Standard Model V1 to strengthen oversight, align operational processes with ICH E6(R3), and demonstrate GCP compliance through:
- TMF Standard Model V1 readiness and impact assessments
- Evaluation of processes that generate and maintain evidence of GCP compliance
- ICH E6(R3) alignment and compliance gap assessments
- Risk-based TMF management and sponsor oversight strategies
- Record classification, metadata, and eTMF optimization
- Inspection readiness and evidence-based oversight assessments
As clinical research and trial management evolve, there is value in periodically looking at the technology that supports it with a fresh perspective.
Not because the technology needs to change.
Because the way we use it can continue to mature.
That is the inspiration behind Veeva Clinical and Veeva Quality Cloud Revisited, a new series from Just in Time GCP exploring existing Veeva capabilities through the lens of today’s clinical research environment.