Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Resource Profile: CMCeCTDDocument32S23 - Mappings

Active as of 2024-12-12

Mappings for the cmc-ectd-document-32s23 resource profile.

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

CMCeCTDDocument32S23
Bundleinfrastructure.structure
   identifierFiveWs.identifier
   typeFiveWs.class
   timestampFiveWs.init
   entry
   entry (Composition)
      resourceinfrastructure.documents
   entry (RoutineSubstance)
      resourceadministrative.medication
   entry (Organization)
      resourceadministrative.group
   entry (Excipient)
      resourceadministrative.medication
   entry (RoutineProduct)
      resourceadministrative.medication
   entry (Specification)
      resourceconformance.behavior,clinical.general

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

CMCeCTDDocument32S23
BundleN/A
   entry
   entry (Composition)
   entry (RoutineSubstance)
   entry (Organization)
      resource(also see master files messages)

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

CMCeCTDDocument32S23
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 (RoutineSubstance)
      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 (Excipient)
      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 (RoutineProduct)
      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 (Specification)
      idn/a
      extensionn/a
      modifierExtensionN/A
      resourceAct[classCode=GROUPER;moodCode=DEFN]
      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)

CMCeCTDDocument32S23
BundleClinicalDocument, if bundle.type = document
   identifierClinicalDocument.id
   timestampClinicalDocument.effectiveTime
   entry
   entry (Composition)
      resourceClinicalDocument