TY  - JOUR
A1  - Gulden, Christian
A1  - Blasini, Romina
A1  - Nassirian, Azadeh
A1  - Stein, Alexandra
A1  - Altun, Fatma Betül
A1  - Kirchner, Melanie
A1  - Prokosch, Hans-Ulrich
A1  - Boeker, Martin
T1  - Prototypical clinical trial registry based on fast healthcare interoperability resources (FHIR): design and implementation study
T2  - JMIR medical informatics
N2  - 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.
KW  - clinical trials
KW  - trials registry
KW  - health information interoperability
KW  - data sharing
KW  - HL7 FHIR
Y1  - 2021
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/69268
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-692684
SN  - 2291-9694
N1  - 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).
N1  - Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/20470, first published May 19, 2020.
VL  - 9
IS  - 1, art. e20470
SP  - 1
EP  - 13
PB  - [Verlag nicht ermittelbar]
CY  - Toronto
ER  -