Fig. 3

Mapping the ODM data model to the FHIR resources. Illustrates how the CDISC ODM model (depicted by unshaded rectangles) is overlaid with the FHIR resources. The Metadata section, depicted on the right of the model with red rectangles to represent the FHIR resources, is mapped to the CarePlan resource at the Study and Study Event level, and to the Questionnaire resource to represent the form and its composition. The Data section is depicted on the left of the model with the FHIR resources depicted as blue rectangles. The Patient resource represents the study participant. The ClinicalImpression resource captures the clinical data for this participant and they are both linked to the ODM model at the Subject Data level. As both the EpisodeOfCare and Encounter resource correspond to study events, they are mapped at the StudyEventData level. The QuestionnaireResponse resource captures the form responses and is linked to the form data and its composition. Finally, the Observation resource is used to capture those responses that are more analogous to a patient’s observations