Saving Time With Risk-based UAT During Protocol Amendments

By Richard Young, Vice President, Vault CDMS

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.