| COCT_MT970000UV A_ResearchSubjectEnrollment |
Derived from RMIM: COCT_RM970000UV and HMD: COCT_HD970000UV |
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| SubjectAssignment | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassClinicalTrial, root= "CLNTRL"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| definition [0..1] (Definition3) | |||||||||
| componentOf [1..1] (Component) | |||||||||
| Definition3 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipInstantiatesMaster, root= "INST"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:V:ContextControl, default= "OP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "false"} |
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| treatmentGroupAssignment [1..1] (TreatmentGroupAssignment) | |||||||||
| TreatmentGroupAssignment | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassClinicalTrialTimepointEvent, root= "CTTEVENT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
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| code [1..1] Act (CV) {CWE:D:ActCode} |
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| title [0..1] Act (ED) |
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| Component | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:V:ContextControl} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| studyAtSite [1..1] (StudyAtSite) | |||||||||
| StudyAtSite | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassClinicalTrial, root= "CLNTRL"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [0..*] Observation (DSET<II>) |
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| title [0..1] Observation (ED) |
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| repeatNumber [0..1] Observation (IVL<INT.NONNEG>) |
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| responsibleParty [0..1] (ResponsibleParty) | |||||||||
| verifier [0..*] (Verifier) | |||||||||
| location [1..1] (Location) | |||||||||
| pertinentInformation [0..*] (PertinentInformation2) | |||||||||
| componentOf [1..1] (Component10) | |||||||||
| ResponsibleParty | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationResponsibleParty, root= "RESP"} |
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| contextControlCode [0..1] Participation (CS) {CNE:C:ContextControl:OP} |
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| sitePrincipalInvestigator [1..1] (SitePrincipalInvestigator) | |||||||||
| SitePrincipalInvestigator | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassClinicalResearchInvestigator, root= "CRINV"} |
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| id [0..1] Role (II) |
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| telecom [0..*] Role (COLL<TEL>) |
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| investigatorPerson [0..1] (Person) | |||||||||
| Verifier | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationVerifier, root= "VRF"} |
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| iRBChair [1..1] (IRBChair) | |||||||||
| IRBChair | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassSigningAuthorityOrOfficer, root= "SGNOFF"} |
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| addr [0..*] Role (COLL<AD>) |
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| telecom [0..*] Role (COLL<TEL>) |
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| signingPerson [0..1] (Person) | |||||||||
| representedInstitutionReviewBoard [0..1] (InstitutionReviewBoard) | |||||||||
| InstitutionReviewBoard | |||||||||
| classCode [1..1] (M) Organization (CS) {CNE:V:EntityClassOrganization, root= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| id [0..*] Organization (DSET<II>) |
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| name [0..*] Organization (COLL<EN>) |
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| telecom [0..*] Organization (COLL<TEL>) |
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| Location | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationTargetLocation, root= "LOC"} |
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| contextControlCode [0..1] Participation (CS) {CNE:C:ContextControl:OP} |
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| studySite [1..1] (StudySite) | |||||||||
| StudySite | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassServiceDeliveryLocation, root= "SDLOC"} |
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| id [1..1] Role (II) |
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| location [0..1] (Site) | |||||||||
| serviceProviderResearchOrganization [0..1] (ResearchOrganization) | |||||||||
| Site | |||||||||
| classCode [1..1] (M) Place (CS) {CNE:V:EntityClassPlace, root= "PLC"} |
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| determinerCode [1..1] (M) Place (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| name [0..*] Place (COLL<EN>) |
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| addr [0..1] Place (AD) |
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| ResearchOrganization | |||||||||
| classCode [1..1] (M) Organization (CS) {CNE:V:EntityClassOrganization, root= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| name [0..*] Organization (COLL<EN>) |
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| addr [0..*] Organization (COLL<AD>) |
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| asApprovedResearchOrganization [0..*] (ApprovedResearchOrganization) | |||||||||
| ApprovedResearchOrganization | |||||||||
| classCode [1..1] (M) LicensedEntity (CS) {CNE:V:RoleClassLicensedEntity, root= "LIC"} |
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| id [0..*] LicensedEntity (DSET<II>) |
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| PertinentInformation2 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipPertains, root= "PERT"} |
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| studyInformation [1..1] (StudyInformation) | |||||||||
| Component10 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipHasComponent, root= "COMP"} |
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| contextConductionInd [0..1] ActRelationship (BL){default= "true"} |
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| researchStudy [1..1] (ResearchStudy) | |||||||||
| ResearchStudy | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassClinicalTrial, root= "CLNTRL"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [0..1] Observation (II) |
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| code [0..1] Observation (CD) {CWE:D:ActCode} |
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| title [0..1] Observation (ST) |
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| effectiveTime [0..1] Observation (IVL<TS>) |
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| responsibleParty [0..1] (ResponsibleParty2) | |||||||||
| author [0..*] (Author2) | |||||||||
| authorization [0..*] (Authorization3) | |||||||||
| reference [0..*] (Reference) | |||||||||
| pertinentInformation [0..*] (PertinentInformation1) | |||||||||
| instantiation [0..1] (Definition) | |||||||||
| ResponsibleParty2 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationResponsibleParty, root= "RESP"} |
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| contextControlCode [0..1] Participation (CS) {CNE:C:ContextControl:OP} |
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| studyPrincipalInvestigator [1..1] (StudyPrincipalInvestigator) | |||||||||
| StudyPrincipalInvestigator | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassClinicalResearchInvestigator, root= "CRINV"} |
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| id [0..1] Role (II) |
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| telecom [0..*] Role (COLL<TEL>) |
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| investigatorPerson [0..1] (Person) | |||||||||
| sponsoringDepartment [0..1] (Department) | |||||||||
| Person | |||||||||
| classCode [1..1] (M) Person (CS) {CNE:V:EntityClassPerson, root= "PSN"} |
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| determinerCode [1..1] (M) Person (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| name [0..*] Person (COLL<PN>) |
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| Department | |||||||||
| classCode [1..1] (M) Organization (CS) {CNE:V:EntityClassOrganization, root= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| name [0..*] Organization (COLL<EN>) |
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| Author2 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
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| contextControlCode [0..1] Participation (CS) {CNE:V:ContextControl} |
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| clinicalResearchSponsor [1..1] (ClinicalResearchSponsor) | |||||||||
| ClinicalResearchSponsor | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassClinicalResearchSponsor, root= "CRSPNSR"} |
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| id [0..*] Role (DSET<II>) |
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| sponsorshipAuthorizingResearchSponsor [0..1] (ResearchSponsor) | |||||||||
| ResearchSponsor | |||||||||
| classCode [1..1] (M) Organization (CS) {CNE:V:EntityClassOrganization, root= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| name [0..1] Organization (ON) |
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| addr [0..*] Organization (COLL<AD>) |
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| Authorization3 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipAuthorizedBy, root= "AUTH"} |
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| contractEvent [1..1] (ContractEvent) | |||||||||
| ContractEvent | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassContract, root= "CNTRCT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [0..*] Act (DSET<II>) |
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| code [0..1] Act (CD) {CWE:D:ActCode} |
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| Reference | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipRefersTo, root= "REFR"} |
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| identifiedResearchStudy [1..1] (IdentifiedResearchStudy) | |||||||||
| IdentifiedResearchStudy | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassClinicalTrial, root= "CLNTRL"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [0..*] Observation (DSET<II>) |
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| title [0..1] Observation (ED) |
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| author [0..*] (Author) | |||||||||
| Author | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
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| agent [1..1] (Agent) | |||||||||
| Agent | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassAgent, root= "AGNT"} |
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| code [0..1] Role (CD) {CWE:D:RoleCode} |
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| PertinentInformation1 | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipPertains, root= "PERT"} |
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| studyInformation [1..1] (StudyInformation) | |||||||||
| StudyInformation | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassObservation, root= "OBS"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| code [0..1] Observation (CD) {CWE:D:ActCode} |
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| effectiveTime [0..1] Observation (IVL<TS>) |
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| value [0..1] Observation (ANY) {CWE:D:ObservationValue} |
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| Definition | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipInstantiatesMaster, root= "INST"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:V:ContextControl} |
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| contextConductionInd [0..1] ActRelationship (BL) |
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| studyProtocol [1..1] (StudyProtocol) | |||||||||
| StudyProtocol | |||||||||
| classCode [1..1] (M) Observation (CS) {CNE:V:ActClassClinicalTrial, root= "CLNTRL"} |
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| moodCode [1..1] (M) Observation (CS) {CNE:V:ActMoodDefinition, root= "DEF"} |
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| id [0..*] Observation (DSET<II>) |
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| authorization [0..*] (Authorization) | |||||||||
| Authorization | |||||||||
| typeCode [1..1] (M) ActRelationship (CS) {CNE:V:ActRelationshipAuthorizedBy, root= "AUTH"} |
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| contextControlCode [0..1] ActRelationship (CS) {CNE:V:ContextControl} |
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| contextConductionInd [0..1] ActRelationship (BL) |
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| protocolAuthorization [1..1] (ProtocolAuthorization) | |||||||||
| ProtocolAuthorization | |||||||||
| classCode [1..1] (M) Act (CS) {CNE:V:ActClassRoot, root= "ACT"} |
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| moodCode [1..1] (M) Act (CS) {CNE:V:ActMoodEventOccurrence, root= "EVN"} |
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| id [0..1] Act (II) |
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| code [0..1] Act (CD) {CWE:D:ActCode} |
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| statusCode [0..1] Act (CS) {CNE:V:ActStatus} |
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| author [0..1] (Author3) | |||||||||
| Author3 | |||||||||
| typeCode [1..1] (M) Participation (CS) {CNE:V:ParticipationAuthorOriginator, root= "AUT"} |
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| territorialAuthority [1..1] (TerritorialAuthority) | |||||||||
| TerritorialAuthority | |||||||||
| classCode [1..1] (M) Role (CS) {CNE:V:RoleClassTerritoryOfAuthority, root= "TERR"} |
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| code [0..1] Role (CD) {CWE:D:RoleCode} |
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| territory [0..1] (Agency) | |||||||||
| governingCountry [0..1] (Country) | |||||||||
| Agency | |||||||||
| classCode [1..1] (M) Organization (CS) {CNE:V:EntityClassOrganization, root= "ORG"} |
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| determinerCode [1..1] (M) Organization (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| name [0..*] Organization (COLL<EN>) |
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| Country | |||||||||
| classCode [1..1] (M) Place (CS) {CNE:V:EntityClassCountry, root= "COUNTRY"} |
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| determinerCode [1..1] (M) Place (CS) {CNE:V:EntityDeterminerSpecific, root= "INSTANCE"} |
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| code [0..1] Place (CD) {CWE:V:CountryEntityType} |
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