Comparing SDTM and FHIR® for Real World Data from Electronic Health Records for Clinical Trial Submissions
Riepenhausen S; Mertens C; Dugas M
Research article (journal) | Peer reviewedAbstract
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 about the publication
Journal: Studies in Health Technology and Informatics (Stud Health Technol Inform)
Volume: 281
Page range: 585-589
Status: Published
Release year: 2021
Language in which the publication is written: English
DOI: 10.3233/SHTI210238
Link to the full text: http://www.ncbi.nlm.nih.gov/pubmed/34042643
Keywords: FHIR; Real World Data; SDTM
Authors from the University of Münster
| Dugas, Martin | Institute of Medical Informatics |
| Mertens, Cornelia | Institute of Medical Informatics |
| Riepenhausen, Sarah | Institute of Medical Informatics |