UAT Roadmap: Insider Perspectives of UAT

By Editorial Team on March 5, 2024

Part 6 – Insider Perspectives of User Acceptance Testing (UAT) in an Electronic Data Capture (EDC) System

Across the human and animal health research spectrums, User Acceptance Testing (UAT) is the ultimate test in evaluating the readiness of studies built in Electronic Data Capture (EDC) systems before going live. UAT ensures that a system or software meets the requirements and expectations of study end-users and complies with applicable regulations (e.g., Good Clinical Practices – GCP, Good Laboratory Practices – GLP, and 21 CFR Part 11 – Electronic Records; Electronic Signatures). To conclude our UAT blog series, we had the privilege of interviewing two seasoned professionals who have a wealth of experience in the world of EDC UAT – a Senior Research Associate and a Research & Development Manager at a well-respected research consultancy for the manufacturing, research, and regulatory affairs in the development of animal drugs and biologics. 

What is your role in UAT?

Dividing the focus among team members allows for a more comprehensive approach to the User Acceptance Testing (UAT) process, enabling each person to concentrate on specific aspects of the study build for a more thorough evaluation. Our technical lead leans into the technical aspects of testing, scrutinizing form relationships, data fields, edit checks, and calculations. Our logistical lead focuses on ensuring alignment with protocol requirements, permissions, masking, configuration, and system settings, providing a seamless operational framework. Consulting and cross-checking along the way helps maintain a consistent approach.

How do you prepare your team?

For both testers, thorough preparation is the cornerstone of successful UAT.  

  • Run through a preliminary review – compare the initial build with protocol requirements and form content to ensure alignment.  
  • Review specifications to get a feel for the edit checks and calculations already in place. 
  • A spreadsheet may be useful for tracking who is testing what and to review testing progress. 
  • Invite a site investigator and/or monitor to participate to collect end-user input.  
  • Plan to utilize Prelude’s Feedback feature to streamline UAT. This feature allows the UAT team to provide feedback to builders and track feedback approval and implementation directly in the EDC. 

They stress, “Our initial review is crucial… making sure all configurations are in place before we begin testing is key.” These preparatory steps lay the foundation for smooth testing, preempting potential hurdles and challenges.

How do you handle your findings before going live? 

Collaborate with the sponsor and consider priorities and time constraints. When implementing a change due to a finding, consider the impact the change will have on the study build and possibly data. After implementing a “fix,” retest within a reasonable scope, reviewing any possible implications. Depending on the risk involved with the fix, this might require creating a couple of new cases. 

Maximize the use of Prelude’s Feedback tool to streamline communication and tracking. Some issues can also be handled via email. It may be helpful to reference a specific email within a Feedback item for comprehensive documentation.  

They elaborate, “We rely on Prelude’s feedback systems to track testing progress… it helps document sponsor approval and allows us to ensure each finding is addressed and the resolution verified – all within the EDC system.” 

Any lessons learned that you could share with other UAT teams? 

Do not skip the preliminary work – ensure permissions are appropriate and there is pre-testing before beginning UAT with an eye on how the study build aligns with the protocol and proper utilization of essential features like edit checks and calculations. This approach helps teams save time, money, and potential headaches by minimizing mid-study updates and preventing the loss of cases due to improper system configuration. 

They advise, “Invest time in preliminary work… ensuring the system is ready for testing is essential for success.” 

Review and test project settings, site forms, permissions, invoicing, inventory functionality, etc. 

To ensure a comprehensive testing approach, involve individuals with monitoring and study management experience for different viewpoints.  

Collaborate with stakeholders and make sure the team is aligned on priorities. 

In Conclusion 

When building a study in an Electronic Data Capture (EDC) system, comprehensive User Acceptance Testing (UAT) is critical for ensuring the seamless transition from development to deployment. Investing time and resources in thorough pre-study testing can also help the bottom line for sponsors, since it helps minimize issues that may arise during the live study (when fixes are more complicated). Through these shared insights, we gain a deeper appreciation for the nuances of EDC UAT and its pivotal role in ensuring data integrity and system functionality after going live. 


Learn More About UAT

Navigating User Acceptance Testing (UAT)

Looking to learn more about User Acceptance Testing (UAT)? Explore our collection of resources to understand how UAT ensures that your study database meets study requirements and expectations of end-users and complies with applicable regulations.