Clinical Study Data Flow Maps
Your path to GCP inspection confidence.
Clinical Study Data Flow Maps
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 part of this shift, sponsors are now being asked to provide clinical study data flow maps—visual diagrams that show how data moves across the entire clinical data lifecycle. Yet for many teams, this 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?
In this 90-minute interactive session, we’ll demystify these expectations and walk through how to build a flow map that stands up to inspection. We’ll examine global regulatory drivers under ICH E6(R3) and related guidance from the FDA and EMA, and explore how these principles connect to broader concepts of data architecture and interoperability—the building blocks of an inspection-ready, future-proof clinical data environment.
You’ll learn how 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.
Join us to turn a regulatory challenge into a practical advantage—and lay the groundwork for a transparent, well-controlled clinical data ecosystem.
