Fig. 6

The ClinicalStudyData resource. Describes the elements comprising the ClinicalStudyData resource. This resource has also been generated using the FHIR Build Process [45] based on the FHIR Guide to Designing Resources [46]. The table structure is defined in the Resource Definition page [47], which also provides a definition of the flags; ‘?!’ indicates that the element is a modifying element, while ‘Σ’ indicates that this element is part of the summary set. The event element describes the events occurring throughout the study. An event can be further divided into visits. Each visit defines an investigation, which can be only one of the following: a QuestionnaireResponse resource or a series of Observation or ImagingManifest resources