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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).

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, but does not include the def:DocumentRef child element. The SourceItems element contain 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 when used with an Origin with Type="Derived".

The Type attribute indicates how the data originated.

The Source attribute indicates the party responsible for the data's origin.

The values used for the Type and Source attributes are provided by CDISC Controlled Terminology in the Define-XML package in non-extensible codelists. Users are encouraged to refer to the most recent version of the CDISC Controlled Terminology.

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