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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 value that could be displayed on a CRF or in an analysis display. Refer to the notes about the meaning of Decode under CodeListItem and Coding.
| Code Block | ||||||
|---|---|---|---|---|---|---|
| ||||||
<MetaDataVersion OID="ODMV2.MDV.NF">
<CodeList OID="STUDY.CL.NullReasonCodelist" Name="NullFlavorValueSubset" DataType="text">
<CodeListItem CodedValue="MSK">
<Decode>
<TranslatedText xml:lang="en">Masked</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="NAV">
<Decode>
<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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| Code Block | ||||||||
|---|---|---|---|---|---|---|---|---|
| ||||||||
<ClinicalData StudyOID="ODMV2.NF.EX1.Study" MetaDataVersonOID="ODMV2.NF.EX1.MDV">
<SubjectData SubjectKey="001" TransactionType="Insert">
<StudyEventData StudyEventOID="vstBASE">
<ItemGroupData ItemGroupOID="sfrmDM">
<ItemData ItemOID="svarFHMarriage" IsNull="Yes">
<AuditRecord>
<UserRef UserOID="system"/>
<LocationRef LocationOID="CDISC"/>
<DateTimeStamp>2008-03-17T19:21:58+00:00</DateTimeStamp>
</AuditRecord>
<Annotation SeqNum="67944">
<Flag><FlagValue CodeListOID="STUDY.CL.NullReasonCodelist">Not Applicable</FlagValue></Flag>
</Annotation>
</ItemData>
</ItemGroupData>
</StudyEventData>
<StudyEventData StudyEventOID="vstWEEK1">
<ItemGroupData ItemGroupOID="sfmECG">
<AuditRecord>
<UserRef UserOID="system"/>
<LocationRef LocationOID="CDISC"/>
<DateTimeStamp>2008-03-17T1924T19:21:58+00:00</DateTimeStamp>
</AuditRecord>
<Annotation SeqNum="67944">
<Flag><FlagValue CodeListOID="STUDY.CL.NullReasonCodelist">Masked</FlagValue></Flag>
</Annotation>
</ItemGroupData>
</StudyEventData>
</SubjectData>
</ClinicalData>
|
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