Clinical Study Data Flow Maps

Practical guidance and trial sponsor perspectives on clinical study data flow mapping in the ICH E6(R3) era

Based on insights from a Just in Time GCP virtual forum, that took place in December of 2025, attended by clinical operations, quality, and data leaders across pharma, biotech, and device companies.

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, as a way for regulatory investigators (aka inspectors) to assess:

Data integrity and traceability
Sponsor oversight across vendors and systems
Transparency across the full data lifecycle

For many organizations, this has surfaced gaps in visibility, documentation, and cross-functional alignment.

The goal is not a perfect diagram – it’s a defensible explanation of how study data moves, changes, and is overseen.

What We're Seeing Across the Industry

Insights from a December 2025 virtual session hosted by Just in Time GCP, attended by trial sponsors across pharma, biotech, and device companies.

Who Participated

- - 140 professionals representing pharma, biotech, & device companies
  - 70 different companies sponsoring trials
  - 20 organizations sent cross-functional teams
  - Hosted by Just in Time GCP

Participants represented a broad mix of small, mid-size, and large trial sponsors, with the majority bringing more than a decade of clinical research experience.
The challenges discussed were not theoretical, they reflect real, operational environments.

What They Said

- - 41% HAVE BEEN ASKED for a study data flow map during an inspection
  - ONLY 9% FEEL CONFIDENT showing their study’s data flow during an inspection

While not all sponsors have been formally asked for a clinical data flow map yet, confidence explaining data flow during a GCP inspection remains limited. Many teams expect this request, but don’t feel fully prepared to respond.

The most common barriers weren’t technical tools, but visibility, ownership, and uncertainty around regulatory expectations. Identifying all data sources and systems remains the single biggest challenge.

Lessons from Trial Sponsors

Across the discussion, several points were consistent:

There is no single “correct” data flow map – scope and depth depend on purpose, risk, and study context
Regulatory investigators (aka inspectors) are less focused on perfection and more focused on sponsor understanding and control
Data flow maps are most effective when treated as part of inspection readiness, not a last-minute artifact
Cross-functional collaboration is essential – no single function owns the full picture

How Just in Time GCP Can Help

Just in Time GCP supports sponsors with:

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

If your team needs more structured support, our expert consultants can turn your early mapping drafts into inspection-ready lifecycle documentation.

Download a High-Level Starting Point

For sponsors looking to begin, or refine, their approach, Just in Time GCP has developed a Clinical Study Data Flow Mapping Starting Point.

This resource is designed to help teams:

Identify common pitfalls early
Ask the right cross-functional questions
Clarify scope, ownership, and responsibilities
Align conversations across clinical, data, quality, and vendor teams

This starting point is intentionally high-level. Effective data flow mapping often requires additional layers of documentation, analysis, and coordination based on study-specific needs.

This starting point is designed to help sponsors frame the right questions and boundaries for clinical study data flow mapping. It does not attempt to standardize maps or replace study-specific judgment, governance, or inspection preparation.

Ready to Explore What This Could Look Like for Your Organization?

Following the webinar, several participants asked for more practical support in applying these concepts within their own organizations.

To address that, Just in Time GCP is hosting small-group information sessions that walk through how we support sponsors with clinical study data flow mapping—from initial scoping through execution.

Upcoming Info Sessions

January 14 | 11:00–11:45 AM ET
January 22 | 2:00–2:45 PM ET

These sessions are designed exclusively for trial sponsors and will focus on how Just in Time GCP works with sponsor teams to:

Scope and structure data flow maps and supporting documentation across studies
Select the right level of support based on complexity, risk, and internal resources
Integrate data flow mapping into broader GCP oversight and inspection readiness programs

This is an opportunity to see how our approach works in practice, ask detailed questions, and determine whether our services are the right fit for your organization.