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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 healthcare professionals though , although some is entered directly by humans human subjects. HL7 has developed a standard set of Null Flavor NullFlavor codes represented in an ISO 21090 enumeration.   Clinical study records extracted directly from healthcare records may encounter this coding.

NullFlavors NullFlavor values are indicated in ODM Clinical Data 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 NullFlavors NullFlavor values supported for the study. The Annotation element can be used at any level in the ODM clinical data hierarchy. For With ODM V2v2.0, it this 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  a CodeList element to identify the set of NullFlavors NullFlavor values that are allowed.   For the use case where the study  study data will be sourced by electronic health records using Fast Healthcare Interoperability Resources (FHIR resources), NullFlavors NullFlavor values will be taken from the HL7 Version 3 Null Flavor Value set or NullFlavor Value Set (https://www.healthit.gov/sites/default/files/170299_f_29_hl7_v3_agender_and_nullflavor.pdf) 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 Null Value 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 Null Value 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.

<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>

 <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>