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Element Name
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Annotation

Element XPath(s)
  • /ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter/Coding
  • /ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter/ParameterValue/Coding
  • /ODM/Study/MetaDataVersion/Protocol/StudyIndications/StudyIndication/Coding
  • /ODM/Study/MetaDataVersion/Protocol/StudyInterventions/StudyIntervention/Coding
  • /ODM/Study/MetaDataVersion/Protocol/StudyTargetPopulation/Coding
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion/Coding
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ExclusionCriteria/Criterion/Coding
  • /ODM/Study/MetaDataVersion/StudyEventGroupDef/Coding
  • /ODM/Study/MetaDataVersion/StudyEventDef/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin/Source/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin/Source/SourceItem/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Origin/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Origin/Source/Coding
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Origin/Source/SourceItem/Coding
  • /ODM/Study/MetaDataVersion/ItemDef/Coding
  • /ODM/Study/MetaDataVersion/CodeList/Coding
  • /ODM/Study/MetaDataVersion/CodeList/CodeListItem/Coding
  • /ODM/ClinicalData/Annotations/Annotation/Coding
  • /ODM/ClinicalData/SubjectData/Annotation/Coding
  • /ODM/ClinicalData/SubjectData/StudyEventData/Annotation/Coding
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Annotation/Coding
  • /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Annotation/Coding
Element Textual ValueNone
AttributesCode, System, SystemName, SystemVersion, href, ref, CommentOID
Child ElementsNone
Usage/Business Rules

The Code is a string pattern that identifies a concept as defined by the code system.

The System is a URI that identifies the code system that defines the code. If the code is taken from a code system resource then the URL for the code system should be used to represent the System. SystemName is a readable name for the System. SystemVersion identifies the version of the System. 

The href is a URI that references a definition of the code within the code system.

CommentOID references a unique ID of a CommentDef element that provides the rationale for the use of the Concept.

Code Block
<CodeList OID="CL.NRIND" Name="Reference Range Indicator" DataType="text">
    <EnumeratedItem CodedValue="ABNORMAL">
        <Coding Code="C78802" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        <Coding Code="394844007" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
    </EnumeratedItem>
    <EnumeratedItem CodedValue="HIGH">
        <Coding Code="C78800" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        <Coding Code="281302008" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
    </EnumeratedItem>
    <EnumeratedItem CodedValue="LOW">
        <Coding Code="C78801" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>     
        <Coding Code="281300000" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
    </EnumeratedItem>
    <EnumeratedItem CodedValue="NORMAL">
        <Coding Code="C78727" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        <Coding Code="281301001" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
    </EnumeratedItem>
    <Coding Code="C78736" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
    <Coding Code="442705008" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
</CodeList>

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