Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Resource Profile: CMCeCTDDocument32P10 - Mappings

Active as of 2024-12-12

Mappings for the cmc-ectd-document-32p10 resource profile.

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

CMCeCTDDocument32P10
Bundleinfrastructure.structure
   identifierFiveWs.identifier
   typeFiveWs.class
   timestampFiveWs.init
   entry
   entry (Composition)
      resourceinfrastructure.documents
   entry (FinishedProduct)
      resourceadministrative.medication
   entry (DrugProduct)
      resourceadministrative.medication
   entry (ContainerClosure)
      resourceadministrative.medication
   entry (Organization)
      resourceadministrative.group
   entry (DrugProductComponent)
      resourceadministrative.medication
   entry (ComponentSubstance)
      resourceadministrative.medication
   entry (GraphicsFile)
      resourceinfrastructure.documents
   entry (StructureFile)
      resourceinfrastructure.documents

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

CMCeCTDDocument32P10
BundleN/A
   entry
   entry (Composition)
   entry (FinishedProduct)
   entry (DrugProduct)
   entry (ContainerClosure)
   entry (Organization)
      resource(also see master files messages)

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

CMCeCTDDocument32P10
BundleEntity. Role, or Act,N/A
   link
      idn/a
      extensionn/a
      modifierExtensionN/A
   entry
      idn/a
      extensionn/a
      modifierExtensionN/A
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A
   entry (Composition)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceEntity, Role, or Act,Document[classCode="DOC" and moodCode="EVN" and isNormalAct()]
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A
   entry (FinishedProduct)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceEntity, Role, or Act
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A
   entry (DrugProduct)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceEntity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A
   entry (ContainerClosure)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceEntity, Role, or Act
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A
   entry (Organization)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceEntity, Role, or Act,Organization(classCode=ORG, determinerCode=INST)
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A
   entry (DrugProductComponent)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceEntity, Role, or Act
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A
   entry (ComponentSubstance)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceEntity, Role, or Act
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A
   entry (GraphicsFile)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceEntity, Role, or Act,Document[classCode="DOC" and moodCode="EVN"]
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A
   entry (StructureFile)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceEntity, Role, or Act,Document[classCode="DOC" and moodCode="EVN"]
      search
         idn/a
         extensionn/a
         modifierExtensionN/A
      request
         idn/a
         extensionn/a
         modifierExtensionN/A
      response
         idn/a
         extensionn/a
         modifierExtensionN/A

Mappings for CDA (R2) (http://hl7.org/v3/cda)

CMCeCTDDocument32P10
BundleClinicalDocument, if bundle.type = document
   identifierClinicalDocument.id
   timestampClinicalDocument.effectiveTime
   entry
   entry (Composition)
      resourceClinicalDocument
   entry (FinishedProduct)
   entry (DrugProduct)
   entry (ContainerClosure)
   entry (Organization)
   entry (DrugProductComponent)
   entry (ComponentSubstance)
   entry (GraphicsFile)
      resourcewhen describing a CDA
   entry (StructureFile)
      resourcewhen describing a CDA