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The study metadata includes a CodeList with the list of support null flavor values. The CodeListItem definitions provide the Null Flavor codes as the CodedValue attribute. The Decode provides a label value that could be displayed on a CRF or in an analysis display.
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<MetaDataVersion OID="ODMV2.MDV.NF">
<CodeList OID="STUDY.CL.NullReasonCodelist" Name="NullFlavorValueSubset" DataType="text">
<CodeListItem CodedValue="MSK">
<Decode>
<TranslatedText xml:lang="en">masked<>Masked</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="NAV">
<Decode>
<TranslatedText>temporarily<TranslatedText>Temporarily unavailable</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="NI">
<Decode>
<TranslatedText>No Data Present</TranslatedText>
</Decode>
</CodeListItem>
<Coding Code="V3 Null Flavor Value Set" System="https://terminology.hl7.org/2.0.0/ValueSet-v3-NullFlavor.html"
SystemName="v3.NullFlavor" SystemVersion="2018-08-12"/>
</CodeList>
</MetaDataVersion> |
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The CodeList definition uses an ExternalCodeList element to identify the dictionary and version. The Coding element provides the URI for the HL7 Null Flavor ValuelistValue Set.
| Code Block | ||||
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<MetaDataVersion OID="ODMV2.NF.EX2.MDV">
<!-- Study Event, ItemGroup and Item definitions not shown -->
<CodeList OID="STUDY.CL.NullReasonCodelist" Name="NullFlavorValueSubset" DataType="text">
<ExternalCodeList Dictionary="HL7 Null Flavor Value Set" Version="2018-08-12"/>
<Coding Code="V3 Null Flavor Value Set" System="https://terminology.hl7.org/2.0.0/ValueSet-v3-NullFlavor.html"
SystemName="v3.NullFlavor" SystemVersion="2018-08-12"/>
</CodeList>
</MetaDataVersion> |
The ClinicalData element illustrates use of Null Flavor Annotation for an ItemGroupData (form) where no clinical data is included; i.e, not present in the data. The Flag element within the Annotation provides the null value code NI. The Annotation element appears following the AuditRecord element.
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