In a comparison of EMR and eSource data, we analyzed the medications and medical history documented in the EMR versus the EDC of subjects in active ongoing clinical research studies. The goal was to assess the validity of the assumption of the utility of using EMR data directly.
The present study reveals a significant data deviation between EMR and EDC software. Further, this highlights the need for vigilant data verification by principal investigators.
Additionally, the analysis focused on two critical areas in determining subject eligibility for trials: problem lists and medication history. The results? Only 31.3% of all medication records and 45.7% of all medical problem records were concordant between the EMR and EDC. Remarkably, 98% of all records were modified for clarity. This finding suggests a crucial role for investigators in correcting incomplete, inaccurate, and irrelevant information while transferring data from EMR to EDC.
EMRs were expected to improve the safety and quality of care. But the study indicates that EMR data tends to be inaccurate, cluttered, and redundant. Therefore, despite EMR-to-EDC integration’s potential for improving the quality and timeliness of data in the EDC system, the direct use of EMR data without PI intermediation could result in lower quality and reliability of data. This impacts patient safety and accurate eligibility determination.
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