Origin

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 Name	Origin
Parent Elements	ItemGroupDef, ItemRef
Element XPath(s)	/ODM/Study/MetaDataVersion/ValueListDef/ItemRef/Origin /ODM/Study/MetaDataVersion/ItemGroupDef/Origin /ODM/Study/MetaDataVersion/ItemGroupDef/ItemRef/Origin
Element Textual Value	None
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

Attribute

Schema Datatype or Enumeration

Usage

Definition

Business 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).

Source

text

Optional

Indicates 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).

Example

Origin with FHIR Resource Example

<ItemGroupDef OID="ODM.IG.LB.WBC" Name="WBC Lab Results with Unit" Repeating="No" Type="Section" >
	<!-- Subject -->
	<ItemRef ItemOID="ODM.IT.LB.SUBJID" Mandatory="Yes">
	 	<Origin Type="Collected" Source="Investigator">
			<SourceItems>
				<SourceItem>
					<!-- The Subject-ID is obtained from ResearchSubject.identifier -->
					<Resource Type="HL7-FHIR" Name="ResearchSubject" Attribute="identifier"/>
				</SourceItem>
			</SourceItems>
		</Origin>
	</ItemRef>
	<!-- Collected Leukocytes (White Blood Count) with units -->
	<!-- The value itself -->
	<!-- Remark the reference to the units item using UnitsItemOID -->
	<ItemRef ItemOID="ODM.IT.LB.WBC.LBORRES" Mandatory="Yes" UnitsItemOID="ODM.IT.LB.WBC.LBORRESU">
		<Origin Type="Collected" Source="Investigator">
			<SourceItems>
				<SourceItem>
					<!-- The value itself is obtained from Observation.valueQuantity.value -->
					<Resource Type="HL7-FHIR" Name="Observation" Attribute="valueQuantity.value"/>
				</SourceItem>
			</SourceItems>
    	</Origin>
	</ItemRef>
	<!-- The units for the leukocytes measurement -->
    <ItemRef ItemOID="ODM.IT.LB.WBC.LBORRESU" Mandatory="Yes">
	 	<Origin Type="Collected" Source="Investigator">
			<SourceItems>
				<SourceItem>
					<!-- The value itself is obtained from Observation.valueQuantity.unit -->
					<Resource Type="HL7-FHIR" Name="Observation" Attribute="valueQuantity.unit"/>
				</SourceItem>
			</SourceItems>
    	</Origin>
	</ItemRef>
    <!-- LOINC code of the test to be performed -->
	<Coding Code="26464-8" System="http://loinc.org" SystemName="LOINC" SystemVersion="2.92"/>	
</ItemGroupDef>

Example

Origin with FHIR Resource Example - alternative

<?xml version="1.0" encoding="UTF-8"?>
<ItemGroupDef OID="ODM.IG.LB.WBC" Name="WBC Lab Results with Unit" Repeating="No" Type="Section" >
    <!-- The Subject Identifier -->
    <ItemRef ItemOID="ODM.IT.SUBJID" Mandatory="Yes" />
    <!-- Collected Leukocytes (White Blood Count) with units -->
    <!-- The value itself -->
    <!-- Remark the reference to the units item using UnitsItemOID -->
    <ItemRef ItemOID="ODM.IT.LB.WBC.LBORRES" Mandatory="Yes" UnitsItemOID="ODM.IT.LB.WBC.LBORRESU" />
    <!-- The units for the leukocytes measurement -->
    <ItemRef ItemOID="ODM.IT.LB.WBC.LBORRESU" Mandatory="Yes" />
    <!-- LOINC code of the test to be performed -->
    <Coding Code="26464-8" System="http://loinc.org" SystemName="LOINC" SystemVersion="2.92"/>
	<!-- Alternative way of stating the origin of the data in the group, 
		as coming from an Electronic Health Record using the FHIR API, 
		retrieved by the investigator -->
 	<Origin Type="Collected" Source="Investigator">
    	<SourceItems>
			<SourceItem ItemOID="ODM.IT.LB.SUBJID">
            	<!-- The Subject-ID is obtained from ResearchSubject.identifier -->
				<!-- The ItemOID references the ItemDef providing the metadata -->
                <Resource Type="HL7-FHIR" Name="ResearchSubject" Attribute="identifier"/>
            </SourceItem>
		 	<SourceItem ItemOID="ODM.IT.LB.WBC.LBORRES">
				<!-- The value itself is obtained from Observation.valueQuantity.value -->
			 	<!-- The ItemOID references the ItemDef providing the metadata -->
                <Resource Type="HL7-FHIR" Name="Observation" Attribute="valueQuantity.value"/>
            </SourceItem>
            <SourceItem ItemOID="ODM.IT.LB.WBC.LBORRESU">
				<!-- The value itself is obtained from Observation.valueQuantity.unit -->
			 	<!-- The ItemOID references the ItemDef providing the metadata -->
				<Resource Type="HL7-FHIR" Name="Observation" Attribute="valueQuantity.unit"/>
			</SourceItem>
        </SourceItems>
   </Origin>
</ItemGroupDef>

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Origin