Best Practice Recommendations: User Acceptance Testing for Systems Designed to Collect Clinical Outcome Assessment Data Electronically.

ABSTRACT

Implementing clinical outcome assessments electronically in clinical studies requires the sponsor and electronic clinical outcome assessment (eCOA) provider to work closely together to implement study-specific requirements and ensure consensus-defined best practices are followed. One of the most important steps is for sponsors to conduct user acceptance testing (UAT) using an eCOA system developed by the eCOA provider. UAT provides the clinical study team including sponsor or designee an opportunity to evaluate actual software performance and ensure that the sponsor's intended requirements were communicated clearly and accurately translated into the system design, and that the system conforms to a sponsor-approved requirements document based on the study protocol. The components of an eCOA system, such as the study-specific application, customization features, study portal, and custom data transfers should be tested during UAT. While the provider will perform their own system validation, the sponsor or designee should also perform their due diligence by conducting UAT. A clear UAT plan including the necessary documentation may be requested by regulatory authorities depending on the country. This paper provides the electronic patient-reported outcome (ePRO) Consortium's and patient-reported outcome (PRO) Consortium's best practice recommendations for clinical study sponsors or their designee for conducting UAT with support from eCOA providers to ensure data quality and enhance operational efficiency of the eCOA system. Following these best practice recommendations and completing UAT in its entirety will support a high quality eCOA system and ensure more reliable and complete data are collected, which are essential to the success of the study.