Comparing SDTM and FHIR® for Real World Data from Electronic Health Records for Clinical Trial Submissions
Riepenhausen S; Mertens C; Dugas M
Forschungsartikel (Zeitschrift) | Peer reviewedZusammenfassung
Real world data for use in clinical trials is promising. We compared the SDTM for clinical trial data submission with FHIR® for routine documentation. After categorization of variables by relevance, clinically relevant SDTM items were mapped to FHIR®. About 30% in both were seen as clinically relevant. The majority of these SDTM items were mappable to FHIR® Observation resource.
Details zur Publikation
Fachzeitschrift: Studies in Health Technology and Informatics (Stud Health Technol Inform)
Jahrgang / Bandnr. / Volume: 281
Seitenbereich: 585-589
Status: Veröffentlicht
Veröffentlichungsjahr: 2021
Sprache, in der die Publikation verfasst ist: Englisch
DOI: 10.3233/SHTI210238
Link zum Volltext: http://www.ncbi.nlm.nih.gov/pubmed/34042643
Stichwörter: FHIR; Real World Data; SDTM
Autor*innen der Universität Münster
| Dugas, Martin | |
| Mertens, Cornelia | |
| Riepenhausen, Sarah |