Veeva’s Agile Design approach focuses on user acceptance early in the build process to make testing a non-event at the end.
User Acceptance Testing (UAT) processes have a clear impact on hitting study milestones. Lengthy UAT cycles are the second most common cause of database build delaysi and mistakes that slip through contribute to the $450,000 price tag and 61-day delay associated with the average protocol amendment.ii
User Acceptance Testing is the quality control process for EDC study builds, and they were relatively straightforward 20 years ago when EDCs were introduced. The advanced protocols and adaptive trials that are commonplace today make everything more complex — including UAT.
The Agile Design methodology replaces static, inefficient processes developed around legacy EDCs with iterative and interactive processes better suited to complex trials and sponsor/CRO collaboration. Many organizations using Agile Design with Veeva Vault EDC complete UAT in a matter of days.
Explore the challenges with today’s UAT, and the mechanisms and methods that ensure faster and higher quality UAT for EDC study builds
The Challenges
Numerous factors contribute to a difficult and inefficient UAT process.
- Stakeholders make conflicting requests.
- Interpretations of the specifications can differ.
- Resolving differences takes time and adds delay. Individuals debate over lengthy email exchanges or must find time to discuss offline.
- Stakeholders struggle to find time to review.
- When consolidating comments, the pace of each review is determined by the slowest contributor.
- Senior executives often join late in the process and make requests overturning prior decisions.
- Clinical programmers from the vendor can misinterpret written requests, adding cycles.
- Protocol changes necessitate documentation or re-testing to prove what hasn’t changed.
- Manually tracking what has and hasn’t been tested is difficult—the large volume of edit checks, sometimes upward of 1500, increases the burden.
- Copying checks from other studies complicates tracking, especially when dependencies exist within the rule or edit check.
- Complex edit checks require individual test programs, which themselves must be tested.
Live, Interactive Design Reviews
With Agile Design, user acceptance begins earlier, during live interactive design review meetings. Veeva brings study team members together in a room and online, and updates are made in real-time, with everyone seeing and evaluating the changes together. The ability to see and discuss updates motivates people to make time for in-person meetings, which in turn produces lasting decisions.
Risk-based UAT with Study Difference Reports in Vault EDC
Whether building a database for a new study or amending a current one, traditional UAT is a tedious process due in part to the volume of items to evaluate.
Veeva’s risk-based approach to UAT gives teams the visibility and justification to test only what’s needed. Narrowing the fields and rules for testing saves significant time and effort.
Veeva’s risk-based UAT is enabled by the Study Differential Report, a tool that compares two studies, or two versions of the same study, and identifies all differences—everything added, removed, or changed. By comparing a current study with one that was previously tested, the report surfaces precisely what is new or changed and should therefore be tested.
Conclusion
Agile Design transforms a lengthy UAT process into a fast-paced, proactive activity involving all critical stakeholders. User acceptance begins early, in the design phase, which fosters better collaboration and decision making. Due to the cloud-based development environment, sponsors have direct access to the casebook throughout the entire build. Real-time visibility and collaboration eliminate the delays and miscommunication inherent in traditional UAT cycles.
Technology advances in Vault EDC, such as the system-generated Study Differential Report, minimize the forms and edit checks that need review and testing. These changes make teams more agile and responsive to external demands and shrinking timelines.
ii https://acrpnet.org/2017/04/11/wasting-money-unnecessary-protocol-amendments/