Solving The EHR-To-EDC Challenge: A Scalable-First Approach

Electronic Data Capture (EDC) systems have been utilized in clinical trials for numerous years to gather, sanitize, transmit, and handle data, primarily utilizing electronic case report forms (eCRFs). Despite notable advancements and extensive acceptance of Electronic Health Records (EHRs) following the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, the integration into clinical research has proceeded relatively gradually. EHRs are contemporary records that focus on patients, combining information from diverse healthcare providers involved in a patient's treatment. The wide-scale adoption of EHR systems, with more than 95% of U.S. hospitals adopting them, has enhanced efficiencies, amplified reimbursements, and improved patient care (ONC, 2019).

EHRs have also been shown to enable the connectivity and compatibility necessary for exchanging electronic health information with other platforms, as exemplified by the efforts to enhance collaboration between regional and national Health Information Exchanges (HIEs). HIEs function as secure electronic hubs for patient data, enabling authorized stakeholders to securely access and effortlessly transmit a patient's medical details. Some HIEs even offer the capability to access EHRs without requiring direct point-to-point integrations (ONC, 2023).

Although clinical researchers have been pursuing the use of EHR data on a large scale for conducting clinical studies for a considerable time, numerous obstacles have impeded this advancement. These challenges encompass inadequate interoperability between EHRs and other systems, subpar data quality, and the substantial exertion demanded from research sites to manually convert electronic data from EHRs (and other systems) into EDC systems (Collen, 1990; Garza, 2020).

This white paper aims to resolve a common pain point highlighted by site research coordinators regarding the manual entering of data as opposed to using data that is readily available somewhere else.