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Towards Interoperable Clinical Trial Registries: Design and Implementation of a Prototypical Registry based on Fast Healthcare Interoperability Resources (FHIR)
Christian Gulden;
Romina Blasini;
Azadeh Nassirian;
Alexandra Stein;
Fatma Betül Altun;
Melanie Kirchner;
Hans-Ulrich Prokosch;
Martin Boeker
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 often the same studies need to be registered in different registries with different data entry requirements and interfaces.
Objective:
Investigate 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 provide an architecture and implementation of a multi-site 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.
Citation
Please cite as:
Gulden C, Blasini R, Nassirian A, Stein A, Altun FB, Kirchner M, Prokosch HU, Boeker M
Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study