期刊
JMIR MEDICAL INFORMATICS
卷 9, 期 1, 页码 -出版社
JMIR PUBLICATIONS, INC
DOI: 10.2196/20470
关键词
clinical trials; trials registry; health information interoperability; data sharing; HL7 FHIR
资金
- German Ministry for Education and Research (BMBF) [FKZ 01ZZ1801A/B/C/D/L/M]
This study investigates the use of HL7 FHIR as a standardized format for exchanging and storing clinical trial records, presenting an open-source central trial registry as a prototype. The results demonstrate that FHIR resources facilitate automated data exchange between trial centers and central study registries, establishing a harmonized view of study information from heterogeneous sources.
Background: Clinical trial registries increase transparency in medical research by making information and results of planned, ongoing, and completed studies publicly available. However, the registration of clinical trials remains a time-consuming manual task complicated by the fact that the same studies often need to be registered in different registries with different data entry requirements and interfaces. Objective: This study investigates how Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) may be used as a standardized format for exchanging and storing clinical trial records. Methods: We designed and prototypically implemented an open-source central trial registry containing records from university hospitals, which are automatically exported and updated by local study management systems. Results: We provided an architecture and implementation of a multisite clinical trials registry based on HL7 FHIR as a data storage and exchange format. Conclusions: The results show that FHIR resources establish a harmonized view of study information from heterogeneous sources by enabling automated data exchange between trial centers and central study registries.
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