Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Resource Profile: CodedOrganization - Mappings

Active as of 2024-12-12

Mappings for the cmc-organization resource profile.

Mappings for FiveWs Pattern Mapping (http://hl7.org/fhir/fivews)

CodedOrganization
Organizationadministrative.group
   identifierFiveWs.identifier
   identifier (DUNSNumber)FiveWs.identifier
   identifier (FEINumber)FiveWs.identifier
   activeFiveWs.status
   typeFiveWs.class

Mappings for HL7 V2 Mapping (http://hl7.org/v2)

CodedOrganization
Organization(also see master files messages)
   identifierXON.10 / XON.3
      useN/A
      typeCX.5
      systemCX.4 / EI-2-4
      valueCX.1 / EI.1
      periodCX.7 + CX.8
      assignerCX.4 / (CX.4,CX.9,CX.10)
   identifier (DUNSNumber)XON.10 / XON.3
      useN/A
      typeCX.5
      systemCX.4 / EI-2-4
      valueCX.1 / EI.1
      periodCX.7 + CX.8
      assignerCX.4 / (CX.4,CX.9,CX.10)
   identifier (FEINumber)XON.10 / XON.3
      useN/A
      typeCX.5
      systemCX.4 / EI-2-4
      valueCX.1 / EI.1
      periodCX.7 + CX.8
      assignerCX.4 / (CX.4,CX.9,CX.10)
   activeNo equivalent in HL7 V2
   typeNo equivalent in v2
   nameXON.1
   contact
      addressXAD
   partOfNo equivalent in HL7 V2
   qualificationCER?

Mappings for RIM Mapping (http://hl7.org/v3)

CodedOrganization
OrganizationEntity, Role, or Act,Organization(classCode=ORG, determinerCode=INST)
   textAct.text?
   containedN/A
   extensionN/A
   modifierExtensionN/A
   identifier.scopes[Role](classCode=IDENT)
      idn/a
      extensionn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   identifier (DUNSNumber).scopes[Role](classCode=IDENT)
      idn/a
      extensionn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   identifier (FEINumber).scopes[Role](classCode=IDENT)
      idn/a
      extensionn/a
      useRole.code or implied by context
      typeRole.code or implied by context
      systemII.root or Role.id.root
      valueII.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
      periodRole.effectiveTime or implied by context
      assignerII.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
   active.status
   type.code
   name.name
   alias.name
   description.playingEntity[classCode=PLC determinerCode=INSTANCE].desc
   contact.contactParty
      idn/a
      extensionn/a
      addressn/a,AD
   partOf.playedBy[classCode=Part].scoper
   endpointn/a
   qualificationn/a
      idn/a
      extensionn/a
      modifierExtensionN/A
      identifiern/a
      coden/a
      periodn/a
      issuern/a

Mappings for Interface Pattern (http://hl7.org/fhir/interface)

CodedOrganization
OrganizationParticipantContactable
   identifierParticipant.identifier
   identifier (DUNSNumber)Participant.identifier
   identifier (FEINumber)Participant.identifier
   activeParticipant.active
   nameParticipant.name

Mappings for ServD (http://www.omg.org/spec/ServD/1.0/)

CodedOrganization
OrganizationOrganization
   identifier./Identifiers
      system./IdentifierType
      value./Value
      period./StartDate and ./EndDate
      assigner./IdentifierIssuingAuthority
   identifier (DUNSNumber)./Identifiers
      system./IdentifierType
      value./Value
      period./StartDate and ./EndDate
      assigner./IdentifierIssuingAuthority
   identifier (FEINumber)./Identifiers
      system./IdentifierType
      value./Value
      period./StartDate and ./EndDate
      assigner./IdentifierIssuingAuthority
   active./Status (however this concept in ServD more covers why the organization is active or not, could be delisted, deregistered, not operational yet) this could alternatively be derived from ./StartDate and ./EndDate and given a context date.
   typen/a
   name.PreferredName/Name
   contact
      addressAddress
   partOfn/a