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The ParameterValue contains the value of the study parameter as text content.

Element NameParameterValue
Parent ElementsStudyParameter
Element XPath(s)

/ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter/ParameterValue.

Element Textual ValueNone
AttributesValue
Child Elements(Coding*)
Usage/Business Rules


AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
ValuetextRequired

Value for parent StudyParameter/@Term.

  • When there is a Coding child element, the Values will reflect the requirements of the referenced coding system.


Example

ParameterValue with Coding
<Protocol>
	<StudySummary>
    	<StudyParameter OID="PAR.INDIC" ShortName="INDIC" Term="Trial Indication">
        	<ParameterValue Value="Headache">
            	<Coding Code="D006261" System="https://id.nlm.nih.gov/mesh" SystemName="MESH" SystemVersion="July 2015 International Version"/>
            	<!-- Remark that SNOMED-CT makes a distinction between Migraine (disorder) and Headache (Finding> -->
            	<Coding Code="37796009" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
        	</ParameterValue>
    	</StudyParameter>
	</StudySummary>
	<StudyEventRef ...>...</StudyEventRef>
...
</Protocol>


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