User Acceptance Testing (UAT) is a critical component in the clinical trial process. Its primary goal is to ensure that the electronic case report forms (eCRF) fulfill the requirements for a study utilizing electronic data capture (EDC). By thoroughly testing every eCRF Sponsors, Contract Research Organizations (CROs), as well as research sites need to verify the following:
- That the right data is being collected
- That all data validations are correctly set up
- That the role-dependent access is correct and that the data entry flow is acceptable from an end-user perspective
Only upon successful validation of the above can the study go live.
UAT is traditionally a manual, repetitive, and time-consuming process performed by multiple testers and is inherently error-prone, particularly if no clear guidelines have been established or if a new EDC system is being introduced. UAT is cited as a common cause for study delays, since the time needed for this step in the study setup is often underestimated.
Benefits of automating UAT
Sponsors and CROs face various challenges in running successful clinical trials, including market competition, business transformation, ongoing regulatory guidance changes, and data management challenges. Innovations that reduce inefficiencies in any step of the clinical trial process can accelerate a therapy’s time to market, providing a competitive advantage.
Consider the drawbacks of manual UAT:
- The lack of industry testing standards typically results in writing test scripts from scratch, leading to a non-standardized test process.
- Multiple SOP(s), guidelines and workflows within organizations, that are in most cases Sponsor-specific, can potentially create inconsistencies, leading to delays in finalization of the UAT process.
- Parts of the EDC are often re-validated, which introduces redundancies
Automated UAT can mitigate some of these drawbacks and provide a superior testing solution that includes:
- Streamlined, repeatable processes that the can be easily implemented and adapted across studies
- High-volume testing, leading to a higher quality UAT report
- Risk of error is reduced
- Shorter submission timelines: where manual UAT requires weeks, automated UAT can be reduced to hours.
Automating UAT can contribute to your study success and with the right services partner, it can be a smooth and rewarding process.
Working with a services partner
Manual UAT might often seem like the more straightforward approach, given that most organizations will have the necessary experience and supporting SOPs. On the other hand, many organizations are not familiar with the possibilities of automated UAT and do not have the resources or know-how to implement it. This is where your EDC vendor can assist you.
Outsourcing the eCRF build is an ideal way to get started with automated UAT, particularly if you procure a knowledgeable service partner who can guide you through the process.
While automation is certainly possible for virtually all testing needs, your organization can choose to automate UAT at the rate you prefer. That is, you can choose a hybrid approach rather than automating all testing at once. The automated UAT report can also provide a basis for focused manual testing for a given study.
To ease your transition to automated UAT and to a new EDC system, you might also want to consider outsourcing other aspects of your study to a services partner, including:
- eCRF builds (including automated UAT)
- Study maintenance
- Study setup
- Study conduct including data management and medical coding setup
Timely and thorough UAT plays a big role in the overall study success by ensuring data integrity, eCRF usability and compliance. Automated eCRF UAT ensures fewer protocol deviations, less data cleaning, higher quality data, and shorter submission timelines—all key contributors to study success. Although the significant value that automated UAT brings to individual studies, as well as to entire organizations, might not be fully appreciated today, sponsors and CROs who move aggressively toward automating critical, yet time consuming processes, will set a new gold standard for studies.