Protocol First EDC provides the tools that allows the clinical monitoring and data management team to perform their oversight work. Reports and workflows are optimized for team efficiency and getting the cleanest data.
The system has separate workflows for clinical monitoring and data management for review to ensure that both teams have their independent review of the data. The statuses are tracked and reported in real time to all parties in the system right in their workflow. This avoids having to work through disconnected reports and assessments.
The auto-queries are run from the standard CDISC SDTM dataset driving reusability between studies for the same compound, therapeutic area, and corporate-wide. The logic is versioned and allows the sharing to bring complex edit checks on RECIST or response data because the data is always in the same place.
We have a standard set of reports that available in Excel for the study teams. These reports can be customized to the team to allow for maximum efficiency. They are the typical reports that drive site and study performance and data cleanliness.