Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study (Preprint)

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 Study registration can be improved by using a common standard across study registries to represent study information and alleviate its exchange. We investigate the use of Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) for this purpose. METHODS Design and prototypically implement 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.

Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study

“…The implementation can handle both the addition and removal of local study resources and updates the master records accordingly. The source code of this application is available online [24].…”

“…After merging, 2099 distinct master study records remain, of which 925 are actively recruiting and displayed on the website. The web app is accessible online [27], and the source code is available [24]. Screenshots of the app are displayed in Multimedia Appendix 2.…”