The StudyStructure element describes the general structure of a clinical study with arms, epochs, and workflows.

Element NameStudyStructure
Parent ElementsProtocol
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudyStructure

Element Textual ValueNone
Attributes

None

Child Elements(Description?, Arm*, Epoch*, WorkflowRef?)
Usage/Business Rules
  • Business Rule(s): 
    • Must be provided when the /ODM/@FileType is Transactional and /ODM/@Granularity in (All, AllClinicalData, SingleSite, SingleSubject).
  • Other Information:

    • Each arm is described as a workflow containing references to StudyEventGroupDef elements 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.


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: StudyStructure

StudyStructure
<!-- ODMv2 Simple Arm-Epoch study structure example -->
<Study xmlns="http://www.cdisc.org/ns/odm/v2.0" OID="STUDY.STUDYSTRUCTURE"
    StudyName="Study Structure Example">
    <MetaDataVersion OID="MDV.001" Name="Version 1">
        <Protocol xmlns="http://www.cdisc.org/ns/odm/v2.0">
            <StudyStructure>
                <Description>
                    <TranslatedText xml:lang="en" Type="text/plain">Simple 3 arm study with epochs</TranslatedText>
                </Description>
                <Arm OID="PLACEBO_ARM" Name="Placebo Arm">
                    <Description>
                        <TranslatedText xml:lang="en" Type="text/plain">Placebo arm</TranslatedText>
                    </Description>
                </Arm>
                <Arm OID="LOWDOSE_ARM" Name="Low Dose Arm">
                    <Description>
                        <TranslatedText xml:lang="en" Type="text/plain">Low-dose arm (54 mg)
                            xanomeline)</TranslatedText>
                    </Description>
                </Arm>
                <Arm OID="HIGHDOSE_ARM" Name="High Dose Arm">
                    <Description>
                        <TranslatedText xml:lang="en" Type="text/plain">High-dose arm (81 mg)</TranslatedText>
                    </Description>
                </Arm>
                <!-- Screening epoch -->
                <Epoch OID="EP.SCREENING" Name="Screening Epoch" SequenceNumber="1"/>
                <!-- Treament epoch -->
                <Epoch OID="EP.TREATMENT" Name="Treatment Epoch" SequenceNumber="2"/>
                <!-- Follow-up epoch -->
                <Epoch OID="EP.FOLLOWUP" Name="Follow-up Epoch" SequenceNumber="3"/>
            </StudyStructure>
            <!-- "Cells" within arms/epochs are modeled using "StudyEventGroupDef",
    referencing the arm using the "ArmOID" attribute and the epoch using the "EpochOID" attribute. 
    A "study cell" can have "study elements" which are modeled by "nested" (through the Ref-Def mechanism) StudyEventGroups. 
    Below is an incomplete example: -->
            <StudyEventGroupRef StudyEventGroupOID="CELL.TREATMENT_PLACEBO" Mandatory="Yes"/>
        </Protocol>
        <!-- The placebo arm treatment cell - simple example -->
        <StudyEventGroupDef OID="CELL.TREATMENT_PLACEBO" Name="Placebo Arm Treatment Cell" 
				ArmOID="PLACEBO_ARM" EpochOID="EP.TREATMENT">
            <Description>
                <TranslatedText xml:lang="en" Type="text/plain">Placebo Arm Treatment Cell, containing 2
                    "Elements"</TranslatedText>
            </Description>
            <!-- The two elements and how they follow each other ideally are described by referencing a Workflow.
            In this example, we just use "nested" StudyEvenrGroups -->
            <!-- P.S. Do NOT use "OrderNumber" for defining the order in the cell. 
        "OrderNumber" is only meant for DISPLAY -->
            <StudyEventGroupRef StudyEventGroupOID="EL.TREATMENT_PLACEBO_1" Mandatory="Yes"/>
            <StudyEventGroupRef StudyEventGroupOID="EL.TREATMENT_PLACEBO_2" Mandatory="Yes"/>
        </StudyEventGroupDef>
        <!-- The two "study elements". Just for the example -->
        <StudyEventGroupDef OID="CELL.TREATMENT_PLACEBO_1" Name="Placebo Arm Treatment Element 1">
            <Description><TranslatedText xml:lang="en" Type="text/plain">This element can now e.g. contain "visits/encounters" which can be modeled as "StudyEvent"</TranslatedText></Description>
        </StudyEventGroupDef>
        <StudyEventGroupDef OID="CELL.TREATMENT_PLACEBO_2" Name="Placebo Arm Treatment Element 2">
            <Description><TranslatedText xml:lang="en" Type="text/plain">This element can now e.g. contain "visits/encounters" which can be modeled as "StudyEvent"</TranslatedText></Description>
        </StudyEventGroupDef>
    </MetaDataVersion>
</Study>





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