Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study.
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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.
SUBMITTER: Gulden C
PROVIDER: S-EPMC7837997 | biostudies-literature | 2021 Jan
REPOSITORIES: biostudies-literature
Publications
Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study.
Gulden Christian C Blasini Romina R Nassirian Azadeh A Stein Alexandra A Altun Fatma Betül FB Kirchner Melanie M Prokosch Hans-Ulrich HU Boeker Martin M
JMIR medical informatics 20210112 1
<h4>Background</h4>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.<h4>Objective</h4>This study investigates how Health Level 7 (HL7) Fast Healthcare ...[more]
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