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

  • 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.
Author:Christian GuldenORCiDGND, Romina BlasiniORCiD, Azadeh NassirianORCiD, Alexandra SteinORCiD, Fatma Betül AltunORCiD, Melanie KirchnerORCiD, Hans-Ulrich ProkoschORCiDGND, Martin BoekerORCiDGND
Parent Title (English):JMIR medical informatics
Publisher:[Verlag nicht ermittelbar]
Place of publication:Toronto
Document Type:Article
Date of Publication (online):2021/01/12
Date of first Publication:2021/01/12
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2023/10/24
Tag:HL7 FHIR; clinical trials; data sharing; health information interoperability; trials registry
Issue:1, art. e20470
Article Number:e20470
Page Number:13
First Page:1
Last Page:13
This study was conducted within the MIRACUM consortium. MIRACUM is funded by the German Ministry for Education andResearch (BMBF; funding  number FKZ 01ZZ1801A/B/C/D/L/M).
Preprints (earlier versions) of this paper are available at, first published May 19, 2020.
Dewey Decimal Classification:0 Informatik, Informationswissenschaft, allgemeine Werke / 00 Informatik, Wissen, Systeme / 004 Datenverarbeitung; Informatik
6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):License LogoCreative Commons - CC BY - Namensnennung 4.0 International