Coding

Coding references a symbol from a defined code system. It uses a code defined in a terminology system to associate semantics with a given term, codelist, variable, or group of variables. The presence of a Coding element associates a meaning to its parent element. Including multiple Coding elements for a given parent indicates synonymous meanings provided by different code systems or code system versions.

Element Name	Coding
Parent Element(s)	StudyParameter, ParameterValue, StudyIndication, StudyIntervention, StudyTargetPopulation, Criterion, StudyEventGroupDef, StudyEventDef, ItemGroupDef, Origin, SourceItems, SourceItem, ItemDef, CodeList, CodeListItem, Annotation
Element XPath(s)	/ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter/Coding /ODM/Study/MetaDataVersion/Protocol/StudySummary/StudyParameter/ParameterValue/Coding /ODM/Study/MetaDataVersion/Protocol/StudyIndications/StudyIndication/Coding /ODM/Study/MetaDataVersion/Protocol/StudyInterventions/StudyIntervention/Coding /ODM/Study/MetaDataVersion/Protocol/StudyTargetPopulation/Coding /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion/Coding /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ExclusionCriteria/Criterion/Coding /ODM/Study/MetaDataVersion/StudyEventGroupDef/Coding /ODM/Study/MetaDataVersion/StudyEventDef/Coding /ODM/Study/MetaDataVersion/ItemGroupDef/Coding /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin/Coding /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin/Source/Coding /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin/Source/SourceItem/Coding /ODM/Study/MetaDataVersion/ItemGroupDef/Origin/Coding /ODM/Study/MetaDataVersion/ItemGroupDef/Origin/Source/Coding /ODM/Study/MetaDataVersion/ItemGroupDef/Origin/Source/SourceItem/Coding /ODM/Study/MetaDataVersion/ItemDef/Coding /ODM/Study/MetaDataVersion/CodeList/Coding /ODM/Study/MetaDataVersion/CodeList/CodeListItem/Coding /ODM/ClinicalData/Annotations/Annotation/Coding /ODM/ClinicalData/SubjectData/Annotation/Coding /ODM/ClinicalData/SubjectData/StudyEventData/Annotation/Coding /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/Annotation/Coding /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData/ItemData/Annotation/Coding
Element Textual Value	None
Attributes	Code, System, SystemName, SystemVersion, href, ref, CommentOID
Child Elements	None
Usage/Business Rules

Attribute	Schema Datatype or Enumeration	Usage	Definition	Business Rule(s)
Code	text	Optional	A string pattern that identifies a concept as defined by the code system.	When not provided, all codes in the code system are allowed. For example, when referencing the complete set of codes from the MedDRA code system.
System	URI	Required	Identifies the code system that defines the code. If the code is taken from a code system resource then the URL for the code system should be used.
SystemName	text	Optional	Human readable name for the code system.
SystemVersion	text	Optional	Identifies the version of the code system
Label	text	Optional	Used to link the value to a named MethodDef parameter.
href	URI	Optional	URI reference to the Code definition.
ref	URI	Optional	Reference to a local instance of the code system.
CommentOID	oidref	Optional	Reference to a CommentDef that provides the rationale for the use of the Concept.	Must match the OID attribute of a CommentDef element within in this Study/MetaDataVersion.

Example

Coding for ItemDef

<MetaDataVersion OID="MDV.EXAMPLE" Name="Coding ItemDef Example" xmlns="http://www.cdisc.org/ns/odm/v2.0">
    <!-- Test definition -->
    <ItemGroupDef OID="IG.ALBUMIN_BLOOD" Name="Albumin concentration in blood with unit" Repeating="No" Type="Section">
        <ItemRef ItemOID="IT.ALBUMIN_BLOOD_CONC" Mandatory="Yes" UnitsItemOID="IT.ALBUMIN_BLOOD_UNIT"/>
    </ItemGroupDef>
    <!-- test details -->
    <ItemDef OID="IT.ALBUMIN_BLOOD_CONC" Name="Albumin concentration in blood (serum or plasma)" DataType="float" >
        <Description>
            <TranslatedText xml:lang="en" "Type="text/plain">Albumin concentration in blood (serum or plasma)</TranslatedText>
            <TranslatedText xml:lang="fr" "Type="text/plain">Concentration d'albumin dans le sang (sérum ou plasma)</TranslatedText>
        </Description>
        <!-- Coding, providing the expected LOINC code for the test -->
        <Coding Code="1751-7" System="http://loinc.org" SystemName="LOINC" SystemVersion="2.72"/>
    </ItemDef>
    <!-- Choice of unit for the test -->
    <ItemDef OID="IT.ALBUMIN_BLOOD_UNIT" Name="Unit for blood albumin test" DataType="text">
        <CodeListRef CodeListOID="CL.ALBUMIN_BLOOD_UNIT"/>
    </ItemDef>
    <CodeList OID="CL.ALBUMIN_BLOOD_UNIT" Name="Allowed units for albumin concentration in blood" DataType="text">
        <CodeListItem CodedValue="g/dL">
            <Coding Code="g/dL" System="http://unitsofmeasure.org" SystemName="UCUM"/>
        </CodeListItem>
        <CodeListItem CodedValue="g/L">
            <Coding Code="g/L" System="http://unitsofmeasure.org" SystemName="UCUM"/>
        </CodeListItem>
        <CodeListtem CodedValue="mg/mL">
            <Coding Code="mg/mL" System="http://unitsofmeasure.org" SystemName="UCUM"/>
        </CodeListItem>
    </CodeList>
</MetaDataVersion>

Coding example for CodeListItem elements:

Example

Coding for CodeListItem elements, with Decode elements

            <CodeList OID="CL_SEX" Name="Sex CodeList" DataType="text">
                <CodeListItem CodedValue="F">
                    <Decode>
                        <TranslatedText xml:lang="en" Type="text/plain">Female</TranslatedText>
                        <TranslatedText xml:lang="fr" Type="text/plain">Féminin</TranslatedText>
                        <TranslatedText xml:lang="de" Type="text/plain">Weiblich</TranslatedText>
                        <TranslatedText xml:lang="ko" Type="text/plain">여자</TranslatedText>
                    </Decode>
                    <!-- CDISC Code for "Female" -->
                    <Coding Code="C16576" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
                    <!-- SNOMED-CT code for "Female" - can be useful for EHR extraction -->
                    <Coding Code="248152002" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
                </CodeListItem>
                <CodeListItem CodedValue="M">
                    <Decode>
                        <TranslatedText xml:lang="en" Type="text/plain">Male</TranslatedText>
                        <TranslatedText xml:lang="fr" Type="text/plain">Masculin</TranslatedText>
                        <TranslatedText xml:lang="de" Type="text/plain">Männlich</TranslatedText>
                        <TranslatedText xml:lang="ko" Type="text/plain">남성</TranslatedText>
                    </Decode>
                    <!-- CDISC Code for "Female" -->
                    <Coding Code="C20197" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
                    <!-- SNOMED-CT code for "Male" - can be useful for EHR extraction -->
                    <Coding Code="248153007" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
                </CodeListItem>
                <!-- CDISC CodeList "SEX" -->
                <Coding Code="C66731" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
                <!-- SNOMED-CT code for "Sex" - can be useful for EHR extraction -->
                <Coding Code="263495000" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
            </CodeList>

Example

Coding for CodeListItem elements, without Decode elements

<CodeList OID="CL.NRIND" Name="Reference Range Indicator" DataType="text">
    <CodeListItem CodedValue="ABNORMAL">
        <Coding Code="C78802" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        <Coding Code="394844007" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
    </CodeListItem>
    <CodeListItem CodedValue="HIGH">
        <Coding Code="C78800" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        <Coding Code="281302008" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
    </CodeListItem>
    <CodeListItem CodedValue="LOW">
        <Coding Code="C78801" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>     
        <Coding Code="281300000" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
    </CodeListItem>
    <CodeListItem CodedValue="NORMAL">
        <Coding Code="C78727" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
        <Coding Code="281301001" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
    </CodeListItem>
    <Coding Code="C78736" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
    <Coding Code="442705008" System="http://snomed.info/sct" SystemName="SNOMED-CT" SystemVersion="2019.10.03"/>
</CodeList>

Coding example for CodeList element to complete external code system:

Example

Coding for CodeList elements, reference to external codelist system

<CodeList OID="CL.MEDDRA" Name="Adverse Events Dictionary" DataType="text">
    <Coding System="https://www.meddra.org/" SystemName="MedDRA" SystemVersion="22.0"/>
</CodeList>

Coding example for CodeList element to complete codelist in external code system:

Example

Coding for CodeList elements, reference to external codelist

<CodeList OID="CL.UNIT" Name="Unit" DataType="text">
    <Coding Code="C71620" System="https://www.cdisc.org/standards/terminology" SystemName="CDISC/NCI CT" SystemVersion="2019-12-20"/>
</CodeList>

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Coding