How does CLEHR work?
CLEHR provides a cross-platform interface to EHRs to extract records for patients in studies. It confirms the patient's identity before inclusion. Graticule provides an honest broker solution to receive PHI and de-identify patient data for research. Graticule maintains an independent and compliant infrastructure to operate CLEHR as a SaaS service.
The first step in the data transfer process is subject mapping. CLEHR is designed to manage only accessing patient records based on the approved IRB protocol for each study. It can operate in automatic mode with an optional flow for manual subject mapping. In automatic mode, identified subjects are imported through a mapping file. Optionally CLEHR can be set up for manual subject mapping where a Clinical research coordinator (CRC) manually confirms subjects. On receiving notification of a subject being added, the CRC in the health system will log into CLEHR. The CRC will then confirm the subject details against EHR records and add the subject to the CLEHR data interface list.
In the next step, CLEHR requests and receives data in FHIR format for all confirmed subjects. It de-identifies subject data before transferring to EDC. CLEHR has the built-in infrastructure to conduct quality checks to identify errors including missing or mismatched data. This helps to save time spent on resolving data inaccuracies. CLEHR matches EHR data to EDC fields and transfers de-identified data to the sponsor in bulk.
CLEHR Technology Architecture
FHIR Based
The tool will extract data from your EHR system using FHIR (Fast Healthcare Interoperability Resources). The CLEHR FHIR integration framework is used to scale the solution. The Graticule team supports the primary interface work at your site to implement FHIR interfaces if needed for CLEHR.
Security/Compliance
Graticule hosts the CLEHR study integrator in a secure Amazon Web Services cloud environment. The environment has implemented controls for HIPAA and HITRUST using ClearData compliance management software and undergoes an annual SOC2 audit.