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The StudyStructure element describes the general structure of a clinical study with Armsarms, epochs, Epochs and Workflows. Each arm is described as a workflow containing references to StudyEventGroups that represent the building blocks. The overall structure of the study for all arms can be described in a Workflow that is directly referenced by StudyStructure.

StudyEventGroups can be 'nested' (by reference), so a CDISC SDTM Trial Design "Element" (the basic building block in the trial design) will be represented by a referenced StudyEventGroup from the Arm Workflow.

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workflows.

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StudyStructure Element
StudyStructure Element

The following example illustrates the case of Simple study structure with 3 arms and 3 epochs. The placebo treatment cell has 2 study elements.

Example
titleStudyStructure

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StudyStructure Example
StudyStructure Example


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