When the ICH E6(R3) guideline was finalized in January 2025, it signaled a transformative shift in how clinical trials are governed, executed, and validated. With the guidance now going into effect in the EU, we want to dig into one area that stands out for sponsors of clinical trials: User Acceptance Testing (UAT).
Once considered a tactical activity led by vendors or CROs, UAT is now a strategic responsibility for sponsors and central to inspection readiness, data integrity, and overall trial success. Let’s dive into why it matters, and how sponsors can prepare.
What is UAT and Why Does it Matter?
User Acceptance Testing (UAT) is the process where the Sponsor (or delegate) validates that the system meets their business and protocol requirements and is ready for use in a live clinical study.
ICH E6(R3) promotes a quality-by-design and lifecycle-based approach to clinical systems. UAT plays a critical role at the end of the validation lifecycle, serving as the final confirmation that a system is “fit for purpose.” Fit for purpose in relation to eCOA/ePRO includes assuring the system will meet the needs of the clinical and patient population utilizing the systems to collect critical clinical outcomes. Whether the system is vendor-provided, developed in-house, or configured externally using a fully outsourced enablement model, the sponsor owns the outcome.
What Sponsors are now Responsible for
ICH E6(R3) sets clear expectations for sponsor oversight:
- Confirming that all data acquisition tools are fit for purpose and properly validated prior to being used in the trial.
- Ensuring deviations are logged, resolved, and risk-assessed before go-live.
- Maintaining inspection-ready documentation of UAT activities.
In other words: If the system supports a regulated clinical activity, the sponsor must be in control of its readiness. The new guideline reinforces the importance of complete, contemporaneous, and traceable documentation:
- Test scripts must map to functional and user requirements.
- All test results must be signed, dated, and stored in a GxP-compliant environment.
- Deviations must be documented, resolved, and closed out prior to system release.
- UAT evidence must be readily available to auditors and inspectors upon request.
For sponsors, this means UAT is not just a technical activity to confirm system readiness, it’s a regulatory deliverable.
How to Move Forward: Preparing for ICH E6(R3)
To align with ICH E6(R3), sponsors should take proactive steps now:
- Define and document a formal UAT framework as part of your computerized systems validation (CSV) process leveraging a risk-based approach.
- Assign internal QA or independent third-party oversight to ensure compliance of User Acceptance Testing.
- Educate cross-functional teams on the sponsor’s role in UAT.
UAT Expertise for ICH E6(R3) Alignment
At Studion, we partner with sponsors to deliver end-to-end UAT services, from script development to execution and audit documentation.
Whether you’re launching a new study or auditing existing systems, our team ensures that your UAT process is inspection-ready, efficient, and aligned with ICH E6(R3).
