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The clinical trials data collection process includes standardized practices for managing incomplete subject data. Most subject data is gathered through interactions with health care professionals though some is entered directly by humans subjects. HL7 has developed a standard set of NullFlavor codes represented in an ISO 21090 enumeration. Clinical study records extracted directly from healthcare records may encounter this coding. NullFlavor values are indicated in ODM Clinical Data through the use of a NullFlavor Annotation. A NullFlavor Annotation is an ODM Annotation element with a Flag child element with a codelist reference. The referenced codelist defines the set of NullFlavor values supported for the study. The Annotation element can be used at any level in the ODM clinical data hierarchy. For ODM V2, it means that it can be used with the StudyEventData, ItemGroupData or ItemData elements. For studies that support collection of NullFlavor information, the ODM MetaDataVersion must include a CodeList element to identify the set of NullFlavor values that are allowed. For the use case where the study data will be sourced by electronic health records using FHIR resources, NullFlavor values will be taken from the HL7 Version 3 NullFlavor Value Set or a defining value subset. When the value of a variable cannot be collected, the ItemData element will have the IsNull attribute set to "Yes" and an Annotation child element that provides the applicable NullValue Code. When a StudyEvent identified in a data request or study workflow does not occur, a NullValue Annotation will be provided as a child element of the StudyEventData element. If a Form/Data Collection Instrument is skipped or has no values entered, the NullValue Annotation is provided as a child element of the ItemGroupData element. See HL7, Defining Value Sets, http://build.fhir.org/ig/HL7/fhir-shorthand/reference.html#defining-value-sets; and ValueSet: NullFlavor, https://terminology.hl7.org/2.0.0/ValueSet-v3-NullFlavor. |
Examples
Example 1 Support for a pre-specified set of null flavors
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Refer to the notes about the meaning of Decode under CodeListItem and Codingin Sections 3.2.2.1.7, Coding, and 3.2.2.1.13, CodeListItem.
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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</TranslatedText>
</Decode>
</CodeListItem>
<CodeListItem CodedValue="NA">
<Decode>
<TranslatedText>Not Applicable</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>
<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> |
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