DocumentIdentifier

: Public Class

Created:	5/20/2008 2:40:02 PM
Modified:	5/28/2013 11:51:12 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{DEA2C424-82D2-45ba-AC6C-5D51BFB00A2E}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SA: Statistical Analysis, View AE: Adverse Event, View CM: Common, View PR: Protocol Representation, Study Versioning View, View RG: Regulatory, View SC: Study Conduct

DEFINITION: The unique identification of a document in a specified context. EXAMPLE(S): In context of a study protocol document, document identifiers are the various unique identifiers assigned to a study by different organizations. OTHER NAME(S): NOTE(S): This class is a resolution of the requirement for noting the type of an identifier which is not handled by the purely technical HL7 II data type.

Attributes
Associations To
Tagged Values
Constraints

Attribute

Public II
identifier

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:1. to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=AmendmentFollowUpReport.reportAmendedIdentifier
Map:AE=SafetyReport.alternateIdentifier
Map:AE=Study.primaryIdentifier
Map:AE=SafetyReport.identifier
Map:AE=Study.additionalIdentifier
Map:C3PR=Identifier.value
Map:C3PRv2.9=RemoteStudy.externalId
Map:C3PRv2.9=Identifier.value
Map:caAERSv2.2=Identifier.value > Study
Map:CDASHv1.1=DS.STUDYID
Map:CDASHv1.1=QS.STUDYID
Map:CDASHv1.1=DV.STUDYID
Map:CDASHv1.1=DA.STUDYID
Map:CDASHv1.1=LB.STUDYID
Map:CDASHv1.1=MH.STUDYID
Map:CDASHv1.1=AE.STUDYID
Map:CDASHv1.1=DM.STUDYID
Map:CDASHv1.1=VS.STUDYID
Map:CDASHv1.1=SC.STUDYID
Map:CDASHv1.1=IE.STUDYID
Map:CDASHv1.1=PE.STUDYID
Map:CDASHv1.1=SU.STUDYID
Map:CDASHv1.1=EG.STUDYID
Map:CDASHv1.1=CM.STUDYID
Map:CDASHv1.1=EX.STUDYID
Map:CDASHv1.1=MB.STUDYID
Map:CTGOV=IND/IDE Serial Number
Map:CTGOV=Organization's Unique Protocol ID
Map:CTGOV=Secondary IDs
Map:CTOM=Protocol.nciIdentifier
Map:CTOM=Protocol.navyNCIIdentifier
Map:CTOM=StudySite.localProtocolIdentifier
Map:CTOM=PartcipantEligibilityAnswer.checklistNumber
Map:CTR&Rr2=US NCT number
Map:CTR&Rr2=WHO UTRN
Map:CTR&Rr2=Other Identifier
Map:CTR&Rr2=Sponsor protocol number
Map:CTR&Rr2=ISRCTN number
Map:CTR&Rr2=EudraCT number
Map:CTRPv1.0=InterventionalStudyProtocol.identifier
Map:CTRPv1.0=StudyProtocol.identifier
Map:CTRPv1.0=Document.identifier
Map:CTRPv1.0=StudyParticipation.localStudyProtocolIdentifier
Map:CTRPv1.0=ObservationalStudyProtocol.identifier
Map:CTRPv3.8=Document.identifier
Map:CTRPv3.8=StudyProtocol.otherIdentifiers
Map:CTRPv3.8=StudyProtocol.assignedIdentifier
Map:CTRR=Protocol Identifier
Map:CTRR=Registry Protocol Identifier
Map:CTRRr3=DocumentIdentifier.identifier
Map:CTRRr3=StudyAgent.expandedAccessRecordIdentifier
Map:CTRv1.0=DocumentIdentifier.identifier
Map:FDA HL7 SD SD DSTU2012=StudyProtocol.id
Map:FDA HL7 SD SD DSTU2012=relatedDocument.setId
Map:FDA HL7 SD SD DSTU2012=StudyProtocol.setID
Map:FDA HL7 SD SD DSTU2012=relatedDocument.id
Map:HCTv1.0=CDE 2692926:Recipient Identification.Study ID# What is the study ID number?
Map:HL7SD=PlannedStudy.setID
Map:HL7SP=Study.id
Map:HL7SP=PlannedStudy.id
Map:HSDBv1.0=[Sponsor].Sponsor protocol no
Map:HSDBv1.0=[Study].Lead Organization Trial Identifier
Map:HSDBv1.0=[Study].Unique Trial Identifier
Map:ICSRr2=ControlActEvent.id (in IndividualCaseSafetyReport)
Map:ICSRr2=ResearchStudy.id (in IndividualCaseSafetyReport)
Map:ICSRr2=InvestigativeEvent.id (in IndividualCaseSafetyReport)
Map:ICSRr2=StudyRegistration.id (in IndividualCaseSafetyReport)
Map:ICSRr2=RelatedInvestigation.id (in IndividualCaseSafetyReport)
Map:ICSRr2=document.id (in IndividualCaseSafetyReport)
Map:ICSRr2=StudyRegistration.id
Map:Lab=Study.identifier
Map:LabViewer2.2=Identifier.extension
Map:LabViewer2.2=Identifier.displayable
Map:LabViewer2.2=Identifier.root
Map:LSDAM=DocumentIdentifier.identifier
Map:NCI CRF Standard=CDE 3008882v1.0: Case Report Form Identifier
Map:NCI CRF Standard=CDE 2746459v1.0: Protocol Clinical Study Identifier Number
Map:PGx v1.0=BE.STUDYID
Map:PGx v1.0=PF.STUDYID
Map:PGx v1.0=BS.STUDYID
Map:PGx v1.0=PB.STUDYID
Map:PGx v1.0=RELSPEC.STUDYID
Map:PGx v1.0=SB.STUDYID
Map:PGx v1.0=PG.STUDYID
Map:PSCv2.6=Study.assignedIdentifier
Map:PSCv2.6=StudySecondaryIdentifier.value
Map:SDTM IGv3.1.1=TI.STUDYID
Map:SDTM IGv3.1.1=EG.STUDYID
Map:SDTM IGv3.1.1=LB.STUDYID
Map:SDTM IGv3.1.1=CO.STUDYID
Map:SDTM IGv3.1.1=PE.STUDYID
Map:SDTM IGv3.1.1=SV.STUDYID
Map:SDTM IGv3.1.1=SE.STUDYID
Map:SDTM IGv3.1.1=TA.STUDYID
Map:SDTM IGv3.1.1=AE.STUDYID
Map:SDTM IGv3.1.1=QS.STUDYID
Map:SDTM IGv3.1.1=CM.STUDYID
Map:SDTM IGv3.1.1=IE.STUDYID
Map:SDTM IGv3.1.1=TV.STUDYID
Map:SDTM IGv3.1.1=SU.STUDYID
Map:SDTM IGv3.1.1=SC.STUDYID
Map:SDTM IGv3.1.1=DA.STUDYID
Map:SDTM IGv3.1.1=VS.STUDYID
Map:SDTM IGv3.1.1=TS.STUDYID
Map:SDTM IGv3.1.1=TE.STUDYID
Map:SDTM IGv3.1.1=DM.STUDYID
Map:SDTM IGv3.1.1=MH.STUDYID
Map:SDTM IGv3.1.1=DS.STUDYID
Map:SDTM IGv3.1.1=DV.STUDYID
Map:SDTM IGv3.1.1=EX.STUDYID
Map:SDTM IGv3.1.2=PC.STUDYID
Map:SDTM IGv3.1.2=SE.STUDYID
Map:SDTM IGv3.1.2=MB.STUDYID
Map:SDTM IGv3.1.2=CM.STUDYID
Map:SDTM IGv3.1.2=FA.STUDYID
Map:SDTM IGv3.1.2=SU.STUDYID
Map:SDTM IGv3.1.2=TV.STUDYID
Map:SDTM IGv3.1.2=TA.STUDYID
Map:SDTM IGv3.1.2=VS.STUDYID
Map:SDTM IGv3.1.2=TE.STUDYID
Map:SDTM IGv3.1.2=MH.STUDYID
Map:SDTM IGv3.1.2=QS.STUDYID
Map:SDTM IGv3.1.2=MS.STUDYID
Map:SDTM IGv3.1.2=EG.STUDYID
Map:SDTM IGv3.1.2=PP.STUDYID
Map:SDTM IGv3.1.2=EX.STUDYID
Map:SDTM IGv3.1.2=LB.STUDYID
Map:SDTM IGv3.1.2=AE.STUDYID
Map:SDTM IGv3.1.2=CO.STUDYID
Map:SDTM IGv3.1.2=IE.STUDYID
Map:SDTM IGv3.1.2=DA.STUDYID
Map:SDTM IGv3.1.2=DV.STUDYID
Map:SDTM IGv3.1.2=DS.STUDYID
Map:SDTM IGv3.1.2=SC.STUDYID
Map:SDTM IGv3.1.2=TI.STUDYID
Map:SDTM IGv3.1.2=TS.STUDYID
Map:SDTM IGv3.1.2=SV.STUDYID
Map:SDTM IGv3.1.2=CE.STUDYID
Map:SDTM IGv3.1.2=DM.STUDYID
Map:SDTM IGv3.1.2=PE.STUDYID
Map:Statistics v1.0=DocumentIdentifier.identifier
Map:WHO=Secondary Identifying Numbers
Map:WHO=Primary Registry and Trial Identifying Number

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A unique symbol that establishes identity of the document.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A study protocol identifier is assigned by the National Cancer Institute (NCI).#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A particular document can have one or more ID.#lt;br /#gt;#lt;/p#gt;

Public CD
typeCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:C3PR=Identifier.type
Map:C3PRv2.9=OrganizationAssignedIdentifier
Map:C3PRv2.9=Identifier.typeInternal
Map:caAERSv2.2=Identifier.type > Study
Map:CTR&Rr2=Other Identifier Name
Map:CTRRr3=DocumentIdentifier.typeCode
Map:CTRv1.0=DocumentIdentifier.typeCode
Map:LSDAM=DocumentIdentifier.typeCode
Map:PSCv2.6=Study.provider
Map:PSCv2.6=StudySecondaryIdentifier.name
Map:Statistics v1.0=DocumentIdentifier.typeCode

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of document identifier.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;sponsor protocol number, national number, cooperative group protocol number, CDISC protocol identifying number, registry identifier#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Public BL
primaryIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:C3PR=Identifier.isPrimary
Map:C3PRv2.9=Identifier.primaryIndicator
Map:caAERSv2.2=Identifier.isPrimary > Study
Map:CTRR=Registry Type Code
Map:CTRv1.0=DocumentIdentifier.primaryIndicator
Map:LSDAM=DocumentIdentifier.primaryIndicator
Map:Statistics v1.0=DocumentIdentifier.primaryIndicator

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether this is the main or principal document identifier. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Element	Source Role	Target Role
StudyRegistry Class	Name: assignedDocumentIdentifier	Name: assigningStudyRegistry
Details: DESCRIPTION:<br /></p><p>Each DocumentIdentifier might be assigned by one StudyRegistry. Each StudyRegistry might assign one or more DocumentIdentifier.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Organization Class	Name: assignedDocumentIdentifier	Name: assigningOrganization
Details: DESCRIPTION:<br /></p><p>Each DocumentIdentifier might be assigned by one Organization. Each Organization might assign one or more DocumentIdentifier.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
PerformedStudyAdministrativeActivity Class	Name: assignedDocumentIdentifier	Name: resulted inPerformedStudyAdministrativeActivity
Details: DESCRIPTION:<br /></p><p>Each DocumentIdentifier might be assigned during one PerformedStudyAdministrativeActivity. Each PerformedStudyAdministrativeActivity might result in one DocumentIdentifier.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
SystemOfRecord Class	Name: assignedDocumentIdentifier	Name: assigningSystemOfRecord
Details: DESCRIPTION:<br /></p><p>Each DocumentIdentifier might be assigned by one SystemOfRecord. Each SystemOfRecord might assign one or more DocumentIdentifier.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Document Class	Name: identifyingDocumentIdentifier	Name: identifiedDocument
Details: DESCRIPTION:<br /></p><p>Each DocumentIdentifier always identifies one Document. Each Document might be identified by one or more DocumentIdentifier.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>

Tag	Value
Map:CTRRr3	DocumentIdentifier
Details:
Map:CTRv1.0	DocumentIdentifier
Details:
Map:HL7SP	DocumentIdentifier
Details:
Map:ICSRr2	StudyRegistration (in IndividualCaseSafetyReport)
Details:
Map:ICSRr2	Authorization (in IndividualCaseSafetyReport)
Details:
Map:LSDAM	DocumentIdentifier
Details:
Map:LSDAMv2.2.3Plus	DocumentIdentifier
Details:
Map:Statistics v1.0	DocumentIdentifier
Details:

Constraint	Type	Status
be assigned by Exclusive Or	Invariant	Approved
Details: A DocumentIdentifier is assigned by one and only one of the following: Organization, StudyRegistry, SystemOfRecord.
be assigned by actualIndicator Qualifier	Invariant	Approved
Details: Only Organization with actualIndicator = "true" is valid.
Attribute Set Qualifier	Invariant	Approved
Details: <font color="#0f0f0f">For a given Document and a given DocumentIdentifier.typeCode, only one DocumentIdentifier can have primaryIndicator = "true".</font>