Fig. 4

The clinical research data model in FHIR. Illustrates the metadata (red) and data (blue) resources comprising the clinical data model for describing and capturing the research study natively in FHIR. The study plan can be described using either the ClinicalStudyPlan or PlanDefinition resource. The latter can be further defined using the ActivityDefinition resource. The Questionnaire resource provides the definition for forms within the study plan. A link to the study plan is contained within the ClinicalStudyData resource. The ClinicalStudyData resource encapsulates the clinical data comprising the research study. It facilitates links to the Patient resource, to describe the study participant. It further describes investigations that can be a QuestionnaireResponse or a series of Observation or ImagingManifest resources. The ImagingManifest resource further defines an ImagingStudy resource to describe the imaging study being conducted