Representing Clinical Study Schedule of Activities as FHIR Resources: Required Characteristic Attributes

Abstract

Introduction: The HL7 FHIR interoperability standard is nowimplemented widely to expose healthcare records, and the FHIR definitionalresources are being investigated and developed to enable research studyprotocol requirements to directly support research data collection from the clinicinto sponsors databases. Objective.  Methods:  A minimal setof attributes to model SoA scheduling requirements was identified, tested anddeveloped using graph methods. The model was tested using various standard, complex,and publicly available SoA examples. The ability of these examples to be generatedas FHIR resources compliant with the recently published HL7 Vulcan SoA ProjectImplementation Guide was tested.  Results: A minimum viable set of SoA characteristics hasbeen identified that can generate SoA FHIR Implementation Guide (IG) compliant resourcesconsistent with the scheduling and timing requirements of a study. Conclusion:  A minimumviable set of SoA characteristics able to describe common study timingrequirements for defining, creating, and confirming study specific FHIRresources was developed.  Although this workwas focused on creating SoAs in FHIR format, the same attributes should be presentand identifiable in SoA models in other formats. The findings here thereforemay have a broader applicability for confirming machine-readable SoArequirements.