Presentation at the CDISC US Interchange, Autumn 2020, on fully automated generation of FDA-ready submission datasets (SDTM), starting from EHR repositories, and using the HL7 FHIR API.
The presentation includes the live demo given during the CDISC Interchange. Besides the FHIR API, it uses our LOINC-CDISC mappings developed for LB (extended from the CDISC one), VS, MB and others and their RESTful webservices described at: http://xml4pharmaserver.com/WebServices/LOINC2CDISC_webservices.html.
The demo application itself is open source – the source code can be found at: https://sourceforge.net/p/fhirloinc2sdtm/code/ci/master/tree/.
Further work is planned for also generating EC (Electrocardio), and QS (Questionnaires) datasets fully automatically. Also the use of FHIRPath in the application is planned – currently these are developed for CDISC by Lloyd McKenzie.
Also remark that the application already can use the new “Research” FHIR resources “ResearchSubject” and “ResearchStudy”.
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