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Element NameStudyParameter
Parent ElementsStudySummary
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter

Element Textual ValueNone
Attributes

OID, Term, ShortName

Child Elements(ParameterValue, Coding*)
Usage/Business Rules
  • Requirement
    • Conditional: required if one of more StudyParameter elements is referenced as part of a Workflow.
    • Cardinality: One or more


Study Summary Parameter
<StudySummary>
        <StudyParameter OID="PAR.AGEMIN" Term="Planned Minimum Age of Subjects" ShortName="AGEMIN">
            <ParameterValue Value="18"/>
            <Coding Code="C49693" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        </StudyParameter>
        <StudyParameter OID="PAR.AGEMAX" Term="Planned Maximum Age of Subjects" ShortName="AGEMAX">
            <ParameterValue Value="65"/>
            <Coding Code="C49694" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        </StudyParameter>
        <StudyParameter OID="PAR.PLANSUB" Term="Planned Number of Subjects" ShortName="PLANSUB">
            <ParameterValue Value="300"/>
            <Coding Code="C49692" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        </StudyParameter>
    </StudySummary>
</StudyParameter>



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