FDA Seeks Initiatives for Merging EHR and EDC

FDA Seeks Initiatives for Merging EHR and EDC

The Center for Drug Evaluation and Research (CDER) is seeking proposals for projects to unify electronic data capture from electronic health records (EHR) and electronic data capture (EDC) systems utilized for clinical research for an end-to-end, single-point approach for electronic data capture in clinical research.

An announcement in the Federal Register states that CDER is interested in supporting demonstration projects to investigate the potential of using an end-to-end Electronic Health Record (EHR)-to-Electronic Data Capture (EDC) single-point data capture approach, under established data and implementation standards and regulations.

This is an important step towards resolving the disconnect between EHR and EDC systems, that often creates a hassle at the study centre where data is entered into the EHR as part of the patient file and is then transcribed to an electronic Case Report Form (eCRF) to be captured in the EDC system for research purposes. Eliminating the data transcription process would eliminate the potential for transcription errors, would save time, and provide more accurate data.