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Origin defines the source metadata, where applicable, for ODM ItemRefs or ItemGroupRefs. Origin as a child element replaces the Origin attribute in ODM v1.3 that exists for the ItemDef and ItemGroupDef elements.

The Origin element is based on the def:Origin element in Define-XML v2.1 with the Trace-XML v1.0 extension.

Element NameOrigin
Parent ElementsItemGroupDef, ItemRef
Element XPath(s)
  • /ODM/Study/MetaDataVersion/ValueListDef/ItemRef/Origin
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Origin
  • /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin
Element Textual ValueNone
Attributes

Type, Source

Child Elements

(Description?, SourceItems?, Coding*, DocumentRef*)

The SourceItems element contains SourceItem child elements that reference the source variables, if any, for a given ItemRef. SourceItem elements provide machine-readable traceability and identify specific arguments for a MethodDef, specially when used with an Origin with Type="Derived".

Usage/Business Rules


AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
Type

text

Required

Identifies how the clinical data values were obtained.

  • The list of allowable Origin/@Type attribute values is provided as non-extensible codelists in the CDISC Controlled Terminology, Define-XML package.

* Users are encouraged to refer to the most recent version of the CDISC Controlled Terminology (https://www.cdisc.org/standards/terminology/controlled-terminology).

SourcetextOptionalIndicates the party responsible for the data's origin type.
  • The list of allowable Origin/@Source attribute values  is provided in the CDISC Controlled Terminology, Define-XML package.

* Users are encouraged to refer to the most recent version of the CDISC Controlled Terminology (https://www.cdisc.org/standards/terminology/controlled-terminology).

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