Prototypical clinical trial registry based on fast healthcare interoperability resources (FHIR): Design and implementation study

Gulden C, Blasini R, Nassirian A, Stein A, Altun FB, Kirchner M, Prokosch HU, Boeker M (2021)

Publication Language: English

Publication Type: Journal article

Publication year: 2021

Journal

JMIR Medical Informatics JMIR Publications

Book Volume: 9

Article Number: e20470

Journal Issue: 1

URI: https://medinform.jmir.org/2021/1/e20470

DOI: 10.2196/20470

Open Access Link: https://medinform.jmir.org/2021/1/e20470

Abstract

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.

Authors with CRIS profile

Christian Gulden Lehrstuhl für Medizinische Informatik Hans-Ulrich Prokosch Lehrstuhl für Medizinische Informatik

Involved external institutions

Universitätsklinikum Carl Gustav Carus Dresden DE Germany (DE) Universitätsmedizin Greifswald / Universitätsklinikum Greifswald DE Germany (DE) Justus-Liebig-Universität Gießen DE Germany (DE) Albert-Ludwigs-Universität Freiburg DE Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) DE Germany (DE)

How to cite

APA:

Gulden, C., Blasini, R., Nassirian, A., Stein, A., Altun, F.B., Kirchner, M.,... Boeker, M. (2021). Prototypical clinical trial registry based on fast healthcare interoperability resources (FHIR): Design and implementation study. JMIR Medical Informatics, 9(1). https://doi.org/10.2196/20470

MLA:

Gulden, Christian, et al. "Prototypical clinical trial registry based on fast healthcare interoperability resources (FHIR): Design and implementation study." JMIR Medical Informatics 9.1 (2021).

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