Assessing clinical site readiness for electronic health record (EHR)-to-electronic data capture (EDC) automated data collection

Abstract

BackgroundeSource software is used to automatically copy a patient's electronic health record data into a clinical study's electronic case report form. However, there is little evidence to assist sponsors in identifying the best sites for multi-center eSource studies. MethodsWe developed an eSource site readiness survey. The survey was administered to principal investigators, clinical research coordinators, and chief research information officers at Pediatric Trial Network sites. ResultsA total of 61 respondents were included in this study (clinical research coordinator, 22; principal investigator, 20; and chief research information officer, 19). Clinical research coordinators and principal investigators ranked medication administration, medication orders, laboratory, medical history, and vital signs data as having the highest priority for automation. While most organizations used some electronic health record research functions (clinical research coordinator, 77%; principal investigator, 75%; and chief research information officer, 89%), only 21% of sites were using Fast Healthcare Interoperability Resources standards to exchange patient data with other institutions. Respondents generally gave lower readiness for change ratings to organizations that did not have a separate research information technology group and where researchers practiced in hospitals not operated by their medical schools. ConclusionsSite readiness to participate in eSource studies is not merely a technical problem. While technical capabilities are important, organizational priorities, structure, and the site's support of clinical research functions are equally important considerations.