Webinar: Unpacking TMF Standard Model V1

Date: November 10, 2026

Time: 9 am PT  | 12 pm ET

The TMF Standard Model V1 is the next-generation framework for managing the “trial master file” (TMF)—the complete, inspectable record of a clinical trial. Developed and published in October 2025 by CDISC, this release marks a transformation from the former TMF Reference Model into a full-fledged standard.

The TMF Standard Model V1 provides a scalable, interoperable, future-ready structure: now aligned with modern regulatory expectations and built for automation, analytics and multi-system exchange.

Join us for this live webinar where we will cover:

• The key changes introduced by the TMF Standard Model V1 – what’s new, what’s different, and why those changes matter for your operations.

• The “why” behind the evolution – how this new model supports inspection readiness, regulatory alignment (e.g., ICH E6(R3), EU Regulation 536/2014), and digital/automation enablement.

• Actionable steps your clinical operations team can take today – for example: assessing your current TMF structure and metadata practices, aligning with the new record‐type hierarchy, starting conversations with your CROs/vendors on transition planning, and building readiness for multi-repository and digital exchange.

About the Presenters

Sarah Ruiz is a clinical trial expert with over a decade of experience running site operations, clinical operations, and clinical applications. She uses her interdisciplinary background and well rounded experience to bring the right tech solutions to any clinical trial workflow from study start up to study closeout. Sarah has direct insight into every key player's day to day practices, making her the perfect strategist to work with your team.

Kevin Tate is Chief Revenue Officer of Kivo.io, and will be moderating the discussion.