Use of electronic health record (EHR) data in clinical trials has long been a goal for researchers. However, few demonstrations and fewer evaluative studies have been published. The variability in outcome choice and measurement hinders synthesis of the extant literature. In collaboration with a contemporaneous systematic review of EHR data use in clinical trial data collection, we analyze reported outcomes and recommend a standardized measure set for the evaluation of human safety, data quality, operational efficiency and cost of eSource solutions.
Keywords: Electronic health records; data collection; data quality; data standards; eSource; quality metrics.