Data & Quality
EHR Integration (for Clinical Trials)
EHR integration in clinical research is the secure, standards-based connection between an electronic health record system and a clinical-trial application that enables eligibility screening, data abstraction, and source-data verification without manual transcription.
Manual EHR-to-eCRF transcription is the largest source of data-quality issues and coordinator burden in clinical trials. EHR integration; via FHIR APIs, HL7 v2 interfaces, or CDISC-standard exports; eliminates duplicate data entry, accelerates pre-screening, and supports real-time safety monitoring.
Integration patterns range from read-only eligibility screening (lowest friction) to bidirectional data exchange with eSource (most operationally complex). HIPAA, GDPR, and the IRB-approved data-use scope determine what is permissible at each site.
Related terms
FHIR (Fast Healthcare Interoperability Resources)
FHIR is the HL7-published standard, expressed as a RESTful API and resource-based data model, that enables interoperable exchange of structured healthcare data between EHRs, payers, registries, research systems, and patient applications.
Patient Pre-screening
Patient pre-screening is the process of evaluating individuals against a clinical trial's inclusion and exclusion criteria, before formal screening visits, to identify likely-eligible candidates and reduce screen failure rates.
Real-World Data (RWD) and Real-World Evidence (RWE)
Real-world data (RWD) is healthcare data collected outside the context of a controlled clinical trial; real-world evidence (RWE) is the clinical evidence about an intervention derived from analyzing RWD.
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