Why CTQs, Clinical Data, and TMF Oversight Matter More Than Ever in Risk-Based Review Under ICH E6(R3)
For years, risk review meant one thing: checking documents in the Trial Master File (TMF). In practice, this meant asking questions such as: Have the right files been uploaded? Were they signed on time? Are they in the right places?
These checks are important. However, in reality, they often focus on paperwork completion instead of true oversight. That is why risk-based review under ICH E6(R3) demands more. In addition, regulators now expect sponsors and CROs to demonstrate that oversight is tied to Critical to Quality (CTQ) factors—the processes, data, and responsibilities most essential to participant safety and data reliability.
This shift is at the heart of Donna Dorozinsky’s upcoming CDISC Conference session: “Redefining Risk: Leveraging Clinical Data and Critical to Quality Factors (CTQs) to Drive Compliance in the R3 Era.”
Why Redefining Risk Matters Now
E6(R3) makes one point clear: trial oversight must evolve. Specifically, it must shift from static TMF checks to dynamic, data-informed risk review. That means:
- First, look beyond missing TMF documents and ask directly: where do compliance risks actually live in our study?
- Next, use study-specific data to confirm that obligations were assigned to the right parties.
- Finally, show evidence of compliance that demonstrates accountability across the trial lifecycle.
What you’ll learn at the CDISC + TMF US Interchange
At the 2025 US CDISC Interchange in Nashville on October 13-14, Donna will focus on practical strategies, pulled directly from her decades of experience. In her presentation, she will highlight examples of how leading teams are reframing risk assessment to match the realities of modern trial conduct.
You’ll discover:
- How CTQs can guide risk-based oversight in real time.
- Where hidden compliance risks are most likely to surface.
- Understand what meaningful “evidence of compliance” looks like in the TMF.
- Learn how risk-based review under ICH E6(R3) defines and applies that evidence.
- How TMF oversight ties into the quality drivers that matter most for your study.
Why you should attend
Clinical trials are only growing more complex. As a result, risk-based review under ICH E6(R3) is essential. Therefore, sponsors and CROs must now ensure TMF completeness, data quality, and timely oversight. By doing so, teams can strengthen TMF oversight, improve inspection readiness, and ensure trials are run with quality at their core.
Don’t miss this session at the CDISC Conference—and leave with the tools to redefine how your organization approaches compliance in the R3 era.
