Saving Time with Risk-based UAT during Protocol Amendments

Many in our industry are stuck working in analog processes for clinical trials. Working in a regulated environment has bred a fear of change and we are failing to embrace the opportunities that emerge with new technologies. We need to stop looking out toward future changes and adopt the changes available today.

Whether building a database for your next study or amending a current study, User Acceptance Testing (UAT) is one of those analog processes that is tedious and manual even with an electronic casebook. One customer’s description of their process offered a case in point. Tracking what had and hadn’t changed for a protocol amendment involved printing out system specifications and EDC screenshots of the entire casebook for the active and amended studies. They then manually reviewed pages side-by-side, line-by-line, marking differences with post-it notes and highlighter pens. The process took days of labor and was fraught with potential for human error.

The challenge wasn’t documenting known changes – that was relatively easy. The challenge was in proving that nothing else had changed. Proving the negative took all the work. Veeva’s Study Differential Report was designed to automate that task. Vault CDMS can compare EDC databases at the atomic level to identify anything and everything that has been added, modified, deleted, or remains unchanged. Changes can be the addition or deletion of an entire form, or as minor as a codelist or label change. This customer is now updating their UAT plan to incorporate the Study Differential Report and reflect a risk-based approach in which they only test those items listed in the report as new or having changed from the current version.

How it Works

Vault CDMS users can easily select two different casebook versions for comparison, either two versions within the same study or across studies. The system generates a report that documents all changes between these two versions, including differences in rules, items, picklists, forms, visit schedules, and more. A summary page displays the main additions, changes, or deletions, giving you a quick overview of the big picture. Detailed information is provided for each specific difference, such as the exact change in precision between two number fields. These reports are fully productized; creating fast and reliable documentation of study changes.

It sounds simple in concept, but most EDCs cannot provide this level of visibility. The data model for Vault CDMS was designed from the ground up to support casebook versioning and tracking changes. It also supports lineage tracking for gathering metrics on when and how objects are changed downstream of an eCRF library. Because this customer’s prior EDC couldn’t produce a differences report they did it manually with highlighters and paper taped to the walls. This is an example of how technology limitations constrain processes and create inefficiencies. System-generated documentation is just one of the contributors to building studies quickly in Vault CDMS and with less effort.

I’ll close with a quote from Tanya du Plessis at Bioforum who was speaking at Veeva R&D Summit, “The Study Differential Report in Vault CDMS is amazing. It saves us loads of time when validating a study by telling us exactly what needs review. Now, we are data managers at heart—so we tested the report a number of times before trusting it—and it works great, much like a proc compare in SAS.”

If you would like to see the Study Differential Report in Vault CDMS, I recommend this short 3-minute demo.