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The study metadata includes a two CodeList elements with the list of support null flavor values. The first CodeList, Name="NullFlavorValueSubset" is the one referenced in the rest of the code blocks on this page. The second CodeList, Name="NullFlavorValueSubset2" is provided to illustrate a specific definition of the HL7 Null Flavor code "MSK" for a Blinded study.
. 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, as intended to be used in the study.
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="NA">
<Decode>
<TranslatedText>Not Applicable</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="NAV">
<Decode>
<TranslatedText>Temporarily unavailable<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>
<CodeList OID="STUDY.CL.NullReasonCodelist2" Name="NullFlavorValueSubset2" DataType="text">
<CodeListItem CodedValue="MSK">
<Decode>
<TranslatedText xml:lang="en">Blinded</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> |
In the ODM ClinicalData element, ItemData elements where IsNull is "Yes" include an Annotation element with a Flag element with the CodeListOID attribute set to to "STUDY.CL.NullReasonCodelist", the OID of the NullFlavorValueSet codelist.
| 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<>NA</FlagValue></Flag>
</Annotation>
</ItemData>
</ItemGroupData>
</StudyEventData>
<StudyEventData StudyEventOID="vstWEEK1">
<ItemGroupData ItemGroupOID="sfmECG">
<AuditRecord>
<UserRef UserOID="system"/>
<LocationRef LocationOID="CDISC"/>
<DateTimeStamp>2008-03-24T19:21:58+00:00</DateTimeStamp>
</AuditRecord>
<Annotation SeqNum="67944">
<Flag><FlagValue CodeListOID="STUDY.CL.NullReasonCodelist">Masked<>MSK</FlagValue></Flag>
</Annotation>
</ItemGroupData>
</StudyEventData>
</SubjectData>
</ClinicalData>
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