ICH E6(R3) Clinical Data Integrity & Technology Governance: A Priority Update for Sponsors
ICH E6(R3) introduces new expectations for oversight, data integrity, and quality. Sponsors now face pressure to strengthen how they govern data and technology so their teams can maintain control across complex, multi-vendor environments.
At Beyond Clinical Compliance on September 9 in Philadelphia, Donna Dorozinsky continued her discussion on aligning processes with R3 in her session:
“Aligning Processes with R3: How to Prioritize Updates So Your Clinical Team Doesn’t Waste Time or Miss Critical Risks.”
Breaking R3 into Actionable Process Areas
Donna broke her talk into three priority process areas where sponsors must act:
- Risk Management & Oversight
- Data Integrity & Technology Governance
- QbD & Continuous Improvement
This short clip focuses on the second area — Data Integrity & Technology Governance. Donna explains why sponsors must understand not only what data they collect but how it moves, transforms, and remains accurate throughout its lifecycle.
Watch the 5-minute clip below:
From the Session
R3 requires sponsors to demonstrate complete control over the clinical-data lifecycle — from capture to submission.
Regulators expect sponsors to know where data originate, how they flow between systems, and who owns oversight at each step. Policies and validation alone are not enough. Sponsors need documented, connected workflows that prove integrity is maintained as data move.
In the clip, Donna highlights that:
- Data governance must extend beyond IT ownership or validation.
- Sponsors should define clear controls and accountability for every system interface and data transfer.
- Technology oversight must demonstrate traceability across vendors, systems, and platforms.
This segment illustrates how R3 is driving sponsors to build transparent, well-controlled data ecosystems—where data integrity is actively managed, not assumed.
Three Part Series on Aligning Processes with R3
This clip is the second in a three-part series from Donna’s Beyond Clinical Compliance presentation:
1️⃣ Risk Management & Oversight (click here to view)
2️⃣ Data Integrity & Technology Governance
3️⃣ QbD & Continuous Improvement (coming soon)
Together, these process areas define what proactive, inspection-ready oversight looks like under ICH E6(R3).
When regulators ask, “Show us how your data flows,” will you be ready — with clarity, structure, and confidence.
Building strong governance is one part of the equation. The next step is being able to show how data actually flow through your study.
Regulators are now asking sponsors to provide Clinical Study Data Flow Maps — visual diagrams that trace data movement across the clinical-data lifecycle. These maps connect people, processes, and systems, translating policy into proof of traceability.
