FDA Notice For Source Data Capture From Electronic Health Records: Using Standardized Clinical Research Data

In December 2015, the United States Food and Drug Administration (FDA) launched its electronic health record (EHR) e-Source to support clinical research projects. The goal of EHR-eSource is to support projects to test the capability and evaluate performance of using an end-to-end EHR to Electronic Data Capture single-point data capture using established data and implementation standards in a regulated clinical research environment. This notice released in June 2015 describes the initiative and sought stakeholder comments on six topics . . .