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Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment
Sarah Gordon1, Jennifer Crager2, Cindy Howry3
1PPD, Wilmington, NC, USA.
Therapeutic Innovation & Regulatory Science
|March 2, 2022
Summary
User Acceptance Testing (UAT) is crucial for electronic clinical outcome assessment (eCOA) systems. Following best practices ensures high-quality data and operational efficiency in clinical studies.
Area of Science:
- Clinical research informatics
- Data management in clinical trials
- Regulatory science
Background:
- Implementing electronic clinical outcome assessments (eCOA) requires close collaboration between sponsors and eCOA providers.
- User Acceptance Testing (UAT) is a critical step to validate eCOA system performance against sponsor requirements and study protocols.
- Regulatory authorities may require clear UAT plans and documentation.
Purpose of the Study:
- To provide best practice recommendations for conducting UAT of eCOA systems.
- To ensure data quality and enhance operational efficiency in clinical studies utilizing eCOA.
- To guide clinical study sponsors and their designees in performing thorough UAT with eCOA provider support.
Main Methods:
- Development of best practice recommendations by the electronic patient-reported outcome (ePRO) Consortium and the patient-reported outcome (PRO) Consortium.
- Focus on sponsor or designee conducting UAT with eCOA provider support.
- Emphasis on testing all components of an eCOA system, including study-specific applications, customization, study portals, and data transfers.
Main Results:
- Following best practice recommendations for UAT supports the development of high-quality eCOA systems.
- Thorough UAT ensures more reliable and complete data collection, essential for study success.
- Collaboration between sponsors and eCOA providers during UAT enhances data integrity and operational efficiency.
Conclusions:
- Comprehensive UAT is indispensable for the successful implementation of eCOA systems in clinical studies.
- Adherence to best practices in UAT guarantees the collection of high-quality, reliable data.
- Effective UAT contributes significantly to the overall success and efficiency of clinical research utilizing electronic data capture.
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