2024: The Year Of EHR eSource In Clinical Trials

By Cal Collins

EHR eSource, as defined by the FDA, refers to electronic source data initially recorded in electronic format, encompassing original records and certified copies of clinical findings or observations captured before or during a clinical investigation. The FDA's 2018 endorsement of EHR eSource emphasized the importance of structured data exchange between electronic health record (EHR) and electronic data capture (EDC) systems, aiming to streamline data entry at the point of care and reduce the need for manual re-entry or verification.

The anticipated surge in momentum suggests that 2024 is poised to become the pivotal year for EHR eSource adoption. This shift is underscored by ten compelling reasons, including enhanced efficiency, improved data accuracy, and the potential for accelerated clinical trial timelines. The convergence of regulatory support, technological advancements, and the imperative for data interoperability positions EHR eSource as a transformative force in shaping the future of clinical research. As we delve into the intricacies of these ten reasons, a comprehensive understanding emerges, highlighting the multifaceted benefits that EHR eSource holds for optimizing research processes and advancing the quality of healthcare data management in the years to come.