What Proactive Quality Oversight Looks Like in the ICH E6(R3) Era
Reflections Ahead of the SQA Annual Meeting
ICH E6(R3) reinforces something clinical quality leaders have long understood: oversight cannot be reactive.
Sponsors are expected to demonstrate that risks are identified early, controls are implemented deliberately, and systems operate in a way that protects data integrity, trial reliability, and patient safety.
This shift requires a different approach to quality oversight.
Instead of focusing primarily on retrospective review of documentation, organizations must demonstrate evidence that oversight is actively occurring across the lifecycle of a trial. That means connecting risk management, digital system controls, and Quality by Design into a coherent oversight model.
In our upcoming presentation, at the 2026 Society of Quality Assurance (SQA) Annual Meeting on April 11-16 in National Harbor, MD, Donna Dorozinsky and Amanda Beck will explore Proactive Quality Oversight in the ICH E6(R3) Era, and discuss how sponsors can:
- Align risk management with oversight expectations under R3
- Ensure data integrity across modern digital trial environments
- Embed quality into protocol and system design rather than adding controls later
- Demonstrate evidence of oversight during clinical inspections
Donna will also present Introducing the CDISC TMF Standard Model: A Roadmap for QA Professionals in Clinical Trial Oversight, highlighting how the evolving TMF model is helping organizations standardize documentation structures and strengthen oversight visibility across sponsors and partners.
Together, these topics reflect a broader reality in modern clinical trials:
Oversight is no longer just about documentation.
It is about demonstrating operational control.
If you will be in National Harbor, we would welcome the opportunity to continue the conversation.
Stop by Booth 205 to meet the Just in Time GCP team and discuss how sponsors are adapting their oversight strategies for the ICH E6(R3) era.
