Compliance Without Compromise: How To Ensure EHR Data Integrity

By Cal Collins

New research shows that the integration of electronic health records (EHRs) with electronic data capture (EDC) systems is both possible and highly effective. A study presented at the AMIA Informatics Summit found that a remarkable 86 percent of clinical trial data points were eligible for automated transfer from EHRs. This integration is gaining momentum because it goes beyond simply reducing manual data entry; it provides a direct line to the source, ensuring data traceability, audit readiness, and confident decision-making.

For complex, adaptive trials like the I-SPY 2 breast cancer study, this integration has proven to be a scalable solution that maintains regulatory-grade standards for data integrity. By automating source data acquisition and providing real-time data validation and end-to-end audit trails, these solutions eliminate the common challenges of inconsistent EHR structures and manual workarounds that increase errors and audit risk. This approach, built with compliance at its core, helps to streamline operations and ensure data is reliable and trustworthy from the start.