HCLS/ClinicalObservationsInteroperability/CDISC

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ODM as RDF

Taking Jozef Artz's HL7-in-ODM example (complete example)

The general structure of ODM is:

<ODM>
  <Study OID="SomeStudy">
    <MetadataVersion Name="SomeStudy_Metadata">
      <ItemGroupDef Name="e.g. Physical Exam">
	<ItemRef itemOID="measured item, e.g. I_HEIGHT"/>
	<ItemRef itemOID="measured item, e.g. I_WEIGHT"/>
      </ItemGroupDef>
      <ItemDef DataType="integer" Length="3" Name="Height" OID="I_HEIGHT" SASFieldName="HEIGHT" SDSVarName="VSORRES">
	<Question><TranslatedText>Height</TranslatedText></Question>
	<range Comparator="LT"><val>220</val><unit>MU_CM</unit></range>
	<range Comparator="LT"><val>90</val><unit>MU_IN</unit></range>
      </ItemDef>
    </MetadataVersion>
  </Study>

  <ReferenceData StudyOID="SomeStudy" MetaDataVersionOID="SomeStudy_Metadata">
    <ItemGroupData ItemGroupOID="IG_PE_BASE">
      <ItemData ItemOID="I_HEIGHT" Value="193" units="MU_CM"/>
      <ItemData ItemOID="I_WEIGHT" Value="90" units="MU_KG"/>
    </ItemGroupData>
  </ReferenceData>

  <ClinicalData>
    <SubjectData SubjectKey="Bob">
      <StudyEventData StudyEventOID="SomeStudy_Event1">
	<FormData FormOID="F_WEEK_1_2">
	  <ItemGroupData ItemGroupOID="IG_COMMON">
	    <ItemData ItemOID="I_SITE" Value="23" />
	    <ItemData ItemOID="I_SUBJECTID" Value="001" />
	    <ItemData ItemOID="I_VISIT" Value="2010-03-13" />
	    <ItemData ItemOID="I_VISITTIME" Value="09:12:28" />
	  </ItemGroupData>
	  <ItemGroupData ItemGroupOID="IG_PE_WEEK">
	    <ItemData ItemOID="I_HEIGHT" Value="193">
	      <MeasurementUnitRef MeasurementUnitOID="MU_CM"/>
	    </ItemData>
	  </ItemGroupData>
	</FormData>
      </StudyEventData>
    </SubjectData>
  </ClinicalData>
</ODM>


path purpose RDF class
Study/MetadataVersion/ItemGroupDef list of variables odm:VariableList
...ItemRef Variable odm:Variable
Study/MetadataVersion/ItemGroupDef/ItemDev description of a variable odm:Input
ReferenceData/ItemGroupData list of reference values odm:ReferenceValueList
...ItemData reference value odm:ReferenceValue
ClinicalData/SubjectData/StudyEventData/FormData list of captured values odm:CapturedValueGroupList
...ItemGroupData collection of values odm:CapturedValueGroup
...ItemData captured value odm:CapturedValue

Presentations at CDISC Europe Interchange


Presentations to US FDA

CDER 5 Nov 2012: call Kerstin's blog comments position paper, slides


Discussion

Semantic models for CDISC based standard and metadata management (slides)

Linking Clinical Data Standards

Kerstin Forsberg's call to respond to US FDA call for study data exchange standards and resulting HCLS IG thread.


Related

CDER


Tools