Clinical Study Data Flow Maps
Practical guidance for trial sponsors on clinical study data flow mapping in the ICH E6(R3) era.
Through ongoing discussions with trial sponsors, Just in Time GCP continues to explore how clinical study data flow mapping is evolving in the ICH E6(R3) era. This educational webinar is designed for trial sponsor teams responsible for clinical operations, data oversight, quality, and study management.
Why Clinical Data Flow Mapping Matters
The regulatory landscape has shifted.
Under ICH E6(R3), regulators are placing greater emphasis on data architecture, lifecycle transparency, and sponsor oversight. Sponsors are increasingly expected to demonstrate not only where clinical data resides, but how it moves, how it is controlled, and how oversight is exercised across systems, vendors, and functions.
As a result, many sponsors are now being asked to describe or demonstrate their clinical study data flows during GCP inspections, allowing regulatory investigators (inspectors) to assess:
- Data integrity and traceability
- Sponsor oversight across vendors and systems
- Transparency across the full data lifecycle
For many organizations, these questions expose gaps in visibility, ownership, and documentation across increasingly complex clinical data environments.
The goal is not to create a perfect diagram, but to provide a clear, defensible explanation of how study data moves, changes, and is overseen.
Where Trial Sponsors Are Seeking Clarity
Across multiple sponsor discussions and recent educational sessions, several recurring questions continue to surface:
- Do we currently maintain a documented view of how study data flows across vendors and systems?
- How detailed should a data flow map actually be to meet regulatory expectations?
- Who owns the map – clinical operations, data management, or quality?
- How do we trace data transformations across multiple vendors and platforms?
- Where are the biggest risk points in our current data ecosystem?
Clinical study data flow mapping is becoming an increasingly important tool for demonstrating data integrity, traceability, and oversight under ICH E6(R3).
Read the Clinical Leader Article by Just in Time GCP’s Founder and CEO, Donna Dorozinsky:
When Sponsors Can’t Explain How Study Data Flows, Inspection Readiness Breaks Down
How Just in Time GCP Can Help
Just in Time GCP helps trial sponsors translate early data flow mapping efforts into inspection-ready lifecycle documentation through:
- Full-study or multi-study data lifecycle mapping
- Cross-functional R3 alignment workshops
- Vendor oversight process optimization
- TMF-integrated data traceability frameworks
- Inspection readiness preparation specific to data lifecycle controls
- Technical + operational harmonization across systems
What We'll Cover in the Webinar
This 90-minute interactive session will walk through the evolving role of clinical study data flow mapping and how trial sponsors are beginning to approach it in practice.
PRESENTATION
Translating Expectations into Actions: The Operational “How-To” of Clinical Study Data Flow Maps
Presenter: Donna Dorozinsky, Founder & CEO, Just in Time GCP
- Why regulators are increasingly asking sponsors to explain how clinical data moves across systems, vendors, and transformations
- What investigators are trying to understand when they request a clinical study data flow map in the ICH E6(R3) era
- The operational steps to define scope, ownership, and structure across systems and vendors
- How to articulate what you need from cross-functional teams to ensure accuracy and traceability
- Practical considerations for aligning data architecture, interoperability, and inspection readiness
- Leveraging data flow maps as a tool to uncover study-level risks
EXPERT PANEL
When the Inspector Asked for a Data Flow Map: What Worked, What Didn’t, and What We’d Do Differently
Experts share firsthand experiences responding to regulatory requests for data flow maps, what approaches worked well, what challenges they faced, and what they’d do differently next time.
- How regulators are requesting and reviewing data flow maps during inspections
- What level of detail and documentation has met expectations
- Coordination across systems, vendors, and functions to demonstrate oversight
- Lessons learned in ensuring traceability and inspection readiness through effective data flow mapping
