Currently, up to 70% of clinical trial data is duplicated between research systems and hospital Electronic Health Records (EHRs), accounting for about 20% of study costs.* With HL7 FHIR standards and SMART on FHIR APIs, large-scale electronic patient data transfer to study databases is now feasible.
EHR to EDC (Electronic Health Record to Electronic Data Capture) or EHR as eSource, streamlines the transfer of EHR data for clinical research. Conducted with patient consent and quality checks, this process meets regulatory eSource requirements, integrating data into an EDC system or the sponsor’s study database without replacing site staff or duplicating data capture.
Automated data transfer minimises site burden, accelerates trial timelines, improves data quality, and enhances patient safety. Additionally, it significantly reduces the need for Source Data Verification (SDV), contributing to overall cost savings. Integrating EHR and EDC systems strengthens relationships with investigational sites, optimises protocols, and enhances clinical trial efficiency.
*Kalankesh L.R, et al. (2024) Utilization of EHRs for clinical trials: a systematic review. BMC Medical Research Methodology BMC Medical Research Methodology Vol 24:70.
Site readiness
- Enabling a network of champion sites for EHR as eSource
- Readiness checklist
- Awareness/education webinars to sites