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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