Latest FDA Guidance Has Implications For EDC And EHR Clinical Study eSource Capabilities

By Elias Tharakan, CTO

The U.S. FDA recently issued additional procedural guidance regarding the Use of Electronic Health Record Data in Clinical Investigations. Although the guidance is non-binding, it is a clear indication for EDC providers who want to reap the benefits for their customers implementing full eSource capabilities, stating “[t]his guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations… FDA encourages sponsors and health care organizations to work with EHR and EDC system vendors to further advance the interoperability and integration of these systems.”

Since issuing initial guidance for industry Electronic Source Data in Clinical Investigations in 2013, the new updates also recommend that eClinical vendors providing EDC, whether directly to sponsors or through a CRO partnership, must move to implement full eSource capabilities that will speed the clinical trial process, reduce costs, and bring greater efficiencies to bringing new drugs and therapies to market.

Gain insight from the results of one company’s eSource study that observed instances as far back as 2007 to just before the initial guidance was released.