Developing FHIR based Activity Libraries to Support Clinical Trial Direct Data Capture

Introduction: The HL7 FHIR standard is widely adopted for sharing healthcare information. FHIR definitional resources are being explored as a means to support research data collection from clinics to study sponsors. A study's schedule of activities (SoA) and activity details must be clearly defined for success. eCRF libraries of SoA activities are developed as sponsor or therapeutic standards for study data management. This work introduces a FHIR-based methodology using graph techniques to create and manage SoA activity libraries, enabling SoA specification in FHIR formats. Objective: This study aimed to (a) develop methodologies for creating and managing activity specifications using FHIR definitional resources and (b) build a library of standardized research SoA activities for implementation by EHRs or other applications. Methods: Python programming and graph methodologies were employed to develop utilities for creating, editing, and managing SoA activity specifications as FHIR resources. Definitions from publicly available sources like LOINC and SNOMED were transformed into graph representations for editing and library management and converted into FHIR resources for study SoA specifications compliant with the HL7 Vulcan SoA Project Implementation Guide. Results: A standardized graph methodology was developed to create and manage SoA activity requirements as FHIR resources. Libraries of common and sponsor-specific activity definitions were built using LOINC data domains to support study requirements. Conclusion: Graph methodologies for defining and managing SoA activity definitions were successfully implemented, generating FHIR interoperability resources. Libraries of standard data domains in FHIR format were created to support clinical research operations.