Reference the Vulcan EHR-to-CR Transfer Implementation Guide published by the HL7 Vulcan Accelerator; the guide defines FHIR R4 profiles for pre-populating case report forms from EHR observations, lab results, and demographics
Configure the EHR FHIR server to expose the required FHIR R4 resource types (Patient, Observation, Condition, MedicationRequest, Procedure) with the Vulcan-defined profiles using the $everything operation or individual resource queries scoped to the trial participant
Map FHIR resource elements to EDC CRF fields using the study's CDASH-to-FHIR element mapping table; LOINC codes in Observation.code map to CDASH test codes, and SNOMED CT in Condition.code maps to medical history terms
Pull EHR data at defined visit windows by querying FHIR resources filtered by patient identifier and date range (Observation?patient={id}&date=ge{visitDate}&date=le{visitDate+window})
Write the pre-populated values to the EDC as provisional (unverified) entries tagged with the source system identifier; the site investigator must review and verify or correct each pre-populated value before the field is marked as clean in the EDC
Maintain an audit record linking each EDC field value to the originating FHIR resource ID and version so the data lineage from EHR to EDC is traceable for GCP inspection purposes
Known gotchas
EHR FHIR servers vary widely in their support of search parameters and profile conformance; validate the specific EHR's FHIR capability statement before building the integration to avoid assuming search parameters are supported
Pre-populated eSource data reduces transcription errors but does not eliminate the need for site investigator source document verification; the SDV requirement under ICH E6(R3) still applies to eSource data, and the monitoring plan must specify how eSource entries are verified
Patient identity matching between the EHR and the EDC must use a validated linkage (e.g., MRN to subject ID mapping table); incorrect patient linkage can result in cross-subject data contamination, a critical data integrity issue
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