EHR2EDC

EHR2EDC leveraged a pre-competitive industry collaboration that brought together global industry actors to improve data sharing for research. This project scaled up and added value to InSite™, a clinical research technology platform developed by the IMI EHR4CR project to facilitate the secondary use of hospital EHR data.

EHR2EDC (Electronic Health Records to Electronic Data Capture systems) allowed for the automatic capture of data from different hospital record systems. This meant that approximately 15% of the data from clinical protocols that had been previously re-entered manually could be transferred automatically. The system reduced human errors, the workload of stakeholders, the complexity of data entry, and the amount of time spent on data collection. The solution developed was fully compliant with relevant regulatory requirements such as GxPs and GDPR.

This project delivered:

• Clinical data standards and mapping-library algorithms, using FHIR (Fast Healthcare Interoperability Resources) profiles, to enable data interoperability between EHRs and EDC systems
• Regulatory acceptance criteria to enable EHR data to be used as an eSource in support of clinical development studies
• InSite Module S3, which was EHR2EDC software that allowed site coordinators and investigators to reduce manual duplicative data entry
• Conduct of Pilot clinical trials at project members' hospitals, to fully validate EHR2EDC capabilities
• Publications and presentations to promote project outputs, to be used within the biomedical research community and foster adoption of developed standards.