Aernoud Fiolet

316 Chapter 13 accuracy, the extensive manual entry by investigators in EDCs could be reduced. If true, data collection efforts could focus on information not available from EHRs and reduce manual EHR-to-EDC data duplication that is now common (Fig. 1). Fig. 1. Layers of data collected during trials left: required trial data collection when not using EHR data in perspective to data available in EHR; right: (theoretical) required trial data collection when using EHR data. METHODS This study was a multicenter, multi-EHR-vendor validation study to assess the accuracy of automated EHR text-mining for trial participant screening and baseline data collection. As a reference standard, we used manual participant screening and data collection by manual data entry in EDCs, which is the current standard for most RCTs.