The Sponsor’s Role in UAT for IRT: What Regulators Expect in 2026

As clinical trial technologies evolve, so do regulatory expectations around User Acceptance Testing (UAT) for IRT (Interactive Response Technology), eCOA, eConsent, and other digital systems. While the core principle of UAT hasn’t changed, confirming the system works as intended, the expectations around who is responsible, how testing is conducted, and what documentation must be inspection-ready have advanced significantly.

For clinical trial sponsors still coming up to speed, the most important shift is clear: Regulators now hold sponsors directly accountable for UAT quality, scope, and readiness for inspection, regardless of whether testing is outsourced to a technology vendor or CRO.

Why the Clinical Trial Sponsor’s Role Matters More Than Ever

Historically, some sponsors relied heavily on vendors or CROs to plan and execute UAT with minimal oversight. Under today’s regulatory lens, this approach is no longer sufficient. Authorities now expect sponsors to demonstrate full ownership of UAT for all clinical technologies, especially IRT, which directly affects drug supply, dosing, randomization, and participant safety.

Global authorities including the FDA, EMA, MHRA, PMDA, and Health Canada consistently reinforce that:

• The sponsor owns the UAT process and must be able to defend it during an inspection.
• UAT must be risk-based, covering scenarios relevant to the protocol and potential patient impact.
• Documentation must be complete, traceable, and ready for inspection at any stage of the trial.

These expectations reflect the broader push to modernize Good Clinical Practice (GCP) standards and the increasing regulatory and industry focus on data-integrity, computerized-system validation, and risk-based oversight. Several recently updated and widely referenced regulatory documents now shape expectations for UAT in clinical trial systems:

• ICH E6(R3) (finalized 2025) – reinforcing sponsor accountability, quality-by-design, and risk-based oversight across trial operations.
• EMA Guideline on Computerized Systems and Data Integrity in Clinical Trials (effective 2023) – defining expectations for validation, audit trails, data lifecycle management, system qualification, and vendor oversight for eClinical systems.
• FDA Computerized Systems Used in Clinical Trials guidance – detailing system validation, documentation, data integrity, audit-trail, and electronic-records/-signatures compliance for clinical trial systems.
• ISPE GAMP Good Practice Guide for Computerized GCP Systems and Data – providing pragmatic frameworks for risk-based validation, lifecycle management, and compliance of eClinical technology.

Key Regulatory Expectations for Sponsors in UAT

While none of these documents prescribe UAT step-by-step, they collectively reinforce the principles that inform modern UAT: validation proportional to risk, demonstration of fitness-for-use, documented vendor oversight, and operationally relevant testing.

1. Define the Scope and Objectives
   • UAT must cover both core system functions and study-specific configurations.
   • Test coverage should be driven by risk assessments tied to patient safety, data integrity, and supply continuity.
2. Own the Test Design
   • Sponsors must ensure that test scripts reflect the trial’s operational reality—not just technical functionality.
   • Include positive and negative testing to validate how the system handles expected and unexpected scenarios.
3. Participate in Execution
   • Sponsor representatives (or qualified third parties acting on their behalf) should be actively involved in running tests—not just reviewing outputs.
4. Document Everything
   • UAT deliverables should include the risk assessment, test plan, executed scripts, defect logs, resolution evidence, and sign-off records.
   • Documentation must be ready for inspection at any stage of the trial.
5. Retain Oversight, Even When Outsourced
   • Partnering with CROs or vendor for UAT doesn’t shift regulatory accountability, sponsors remain responsible for oversight, quality and completeness.

The Shift To Risk-Based, Operationally-Relevant UAT.

One of the most important developments across GCP modernization is the move towards risk-based, operationally relevant UAT. Regulators increasingly expect UAT to demonstrate not just that the system works, but that it works for your study, in your protocol context, with your visit schedule, dosing schemes, kit logic, supply strategies and workflow dependencies.

For eClinical systems, this means:

• Prioritizing protocol-specific scenarios that affect drug supply, dosing, and visit schedules.
• Testing real-world study scenarios rather than overemphasizing generic platform functionality.
• Incorporating exploratory or scenario-driven tests to uncover issues that scripted tests may miss.

How Clinical Supply Consulting (CSC) Supports Sponsor Readiness

At Clinical Supply Consulting, our UAT Services are designed to meet today’s regulatory expectations. We help sponsors:

• Build risk assessments that stand up to regulatory scrutiny.
• Design and execute protocol-specific IRT (and other clinical tech solution) test scenarios that reflect operational realities.
• Validate drug management, resupply logic, and country-specific constraints that aligns with global regulatory standards.

By embedding these practices, sponsors not only meet evolving regulatory expectations—they also strengthen operational confidence in their IRT systems, reduce supply chain risk, and ensure smoother clinical trial exectution.

The Bottom Line with UAT.

Regulators expect sponsors to take an active role, apply a risk-based approach, and ensure their testing reflects the operational realities of their study. Whether done in-house or with expert partners, the responsibility (and the benefits) remains with the sponsor.

Your name is on the inspection report. Make sure your UAT process—and your IRT validation—reflect the level of oversight regulators now expect.

Learn more about CSC’s UAT Services