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) |
|
| 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
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>
Example: Coding for CodeListItem elements, with Decode elements
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
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>
Example: Coding for CodeList elements, reference to external codelist system
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>
Example: Coding for CodeList elements, reference to external codelist
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>