Clinical Study Data Flow Maps
Virtual Education and Networking
December 2, 2025 | 11:00 AM ET - 12:30 PM ET
Understanding Global Regulatory Expectations and a Practical Guidance for Demonstrating Clinical Data Integrity, Traceability and Oversight
Regulators around the world—including the FDA, EMA, and other ICH member agencies—are intensifying their focus on data integrity, traceability, and oversight of clinical data systems and processes. As a result, sponsors are now facing new expectations for transparency and control.
Inspectors Want To See Your Clinical Data Flow Maps
Consequently, they are being asked to provide clinical study data flow maps—visual diagrams that show how data moves across the entire clinical data lifecycle. For many teams, however, this new request raises familiar questions.
- What exactly are regulators expecting to see?
- How detailed should the diagram be?
- Who should own and maintain it—and where do you start?
To answer these questions, this interactive session will explain what regulators are really asking for and how to respond effectively. First, it will break down global regulatory expectations for data-flow mapping under ICH E6(R3) and related guidance from the FDA and EMA. Then, we’ll connect these expectations to broader concepts of data architecture and interoperability—the building blocks of an inspection-ready, future-proof clinical-data environment. In addition, we’ll discuss how these principles translate into operational practice across systems and vendors.
Featured Panel Discussion on Real Inspection Experiences
What Worked, What Didn’t, and What We’d Do Differently
Moderator – Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP
Panelists
Tina Henderson, Head of Life Sciences Consulting, JUST IN TIME GCP
Samelyse Lees, Senior Quality Advisor, GSK
Mallorie Sayre, Associate Director, Clinical Systems Ops & Support, MODERNA
Michael Wieczerzak, Associate Director, Clinical Quality Management, EMD SERONO
What You'll Learn in This Session
By attending, you’ll gain practical insights to:
- Interpret the regulatory rationale behind data flow maps in clinical research.
- Identify data origins, systems, vendors, and transfer pathways across your study.
- Determine the right level of detail for traceability without overcomplicating your map.
- Apply a consistent, structured approach to mapping that aligns with ICH E6(R3).
- Avoid common pitfalls such as missing vendor interfaces or untracked data transformations.
The session will help you turn a regulatory challenge into a practical advantage and, in doing so, lay the groundwork for a transparent, well-controlled clinical data ecosystem.
