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<!-- 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">Simple 3 arm study with epochs</TranslatedText>
</Description>
<Arm OID="PLACEBO_ARM" Name="Placebo Arm">
<Description>
<TranslatedText xml:lang="en">Placebo arm</TranslatedText>
</Description>
</Arm>
<Arm OID="LOWDOSE_ARM" Name="Low Dose Arm">
<Description>
<TranslatedText xml:lang="en">Low-dose arm (54 mg)
xanomeline)</TranslatedText>
</Description>
</Arm>
<Arm OID="HIGHDOSE_ARM" Name="High Dose Arm">
<Description>
<TranslatedText xml:lang="en">High-dose arm (81 mg)</TranslatedText>
</Description>
</Arm>
<!-- Screening epoch with a planned duration of 10 days -->
<Epoch OID="EP.SCREENING" Name="Screening Epoch" SequenceNumber="1"
PlannedDuration="P10D"/>
<!-- Treament epoch with a planned duration of 7 months -->
<Epoch OID="EP.TREATMENT" Name="Treatment Epoch" SequenceNumber="2"
PlannedDuration="P7M"/>
<!-- Follow-up epoch with a planned duration of 2 months -->
<Epoch OID="EP.FOLLOWUP" Name="Follow-up Epoch" SequenceNumber="3"
PlannedDuration="P2M"/>
</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">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">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">This element can now e.g. contain "visits/encounters" which can be modeled as "StudyEvent"</TranslatedText></Description>
</StudyEventGroupDef>
</MetaDataVersion>
</Study> |
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