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 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 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>