biostudies-literatureUnknown9(1)Gulden C<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 Interoperability Resources (FHIR) may be used as a standardized format for exchanging and storing clinical trial records.<h4>Methods</h4>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.<h4>Results</h4>We provided an architecture and implementation of a multisite clinical trials registry based on HL7 FHIR as a data storage and exchange format.<h4>Conclusions</h4>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.JMIR medical informaticse20470https://www.ebi.ac.uk/biostudies/studies/S-EPMC7837997biostudies-literaturePrototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study.PMC7837997Blasini RStein ABoeker MKirchner MNassirian AAltun FBGulden CProkosch HUfalsePrototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study.<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 Interoperability Resources (FHIR) may be used as a standardized format for exchanging and storing clinical trial records.<h4>Methods</h4>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.<h4>Results</h4>We provided an architecture and implementation of a multisite clinical trials registry based on HL7 FHIR as a data storage and exchange format.<h4>Conclusions</h4>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.2021-01-01T00:00:00Z2021 Jan2024-11-20T12:25:23.024Z2021-02-21T05:07:35ZS-EPMC78379973343339310.2196/20470