Since the EDC trial process inherently has fewer process steps than a paper-based system, cycle time measurements are a more accurate representation of each site s actual performance. With EDC data acquisition, the generation of metrics can be transparent to the end user, often a difficult task with traditional clinical trials. Historically, accessing the metrics data set in real-time for early analysis and intervention has been difficult, if not impossible. Not only is the data immediate, but also every data point is tracked and measured, giving a robust and complete data set to work with.
Sponsors can use indicators to examine trends and explore root causes of problems.
With consistent and comparative data, the clinical trial team can proactively apply changes to the trial while it is in process. A key measurement that summarizes the overall health of the trial process is the query rate. Manual queries, which the CRA sends to the CRC, take much longer to process than automatic queries. The number of manual queries per patient is also helpful. The variation from site to site can highlight sites that are having problems with data entry.