Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot United States of America flag

Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Resource Profile: QualitySpecification - Mappings

Active as of 2024-04-04

Mappings for the pqcmc-quality-specification resource profile.

Mappings for Workflow Pattern (http://hl7.org/fhir/workflow)

QualitySpecification
PlanDefinitionDefinition
   urlDefinition.url
   identifierDefinition.identifier
   versionDefinition.version
   versionAlgorithm[x]Definition.versionAlgorithm
   nameDefinition.name
   titleDefinition.title
   statusDefinition.status {different ValueSet}
   experimentalDefinition.experimental
   subject[x]Definition.subject
   dateDefinition.date
   publisherDefinition.publisher
   contactDefinition.contact
   descriptionDefinition.description
   useContextDefinition.useContext
   jurisdictionDefinition.jurisdiction
   purposeDefinition.purpose
   copyrightDefinition.copyright
   copyrightLabelDefinition.copyrightLabel
   approvalDateDefinition.approvalDate
   lastReviewDateDefinition.lastReviewDate
   effectivePeriodDefinition.effectivePeriod
   topicDefinition.subject[x]
   action{Is a contained Definition}
      titleDefinition.title
      descriptionDefinition.description
      textEquivalentDefinition.description
      subject[x]Definition.subject
      action{InverseRelationship of Definition.partOf}
         titleDefinition.title
         descriptionDefinition.description
         textEquivalentDefinition.description
         subject[x]Definition.subject
         action{InverseRelationship of Definition.partOf}
            titleDefinition.title
            descriptionDefinition.description
            textEquivalentDefinition.description
            subject[x]Definition.subject
            action{InverseRelationship of Definition.partOf}

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

QualitySpecification
PlanDefinitionconformance.behavior,clinical.general
   urlFiveWs.identifier
   identifierFiveWs.identifier
   versionFiveWs.version
   versionAlgorithm[x]FiveWs.version
   statusFiveWs.status
   experimentalFiveWs.class
   dateFiveWs.recorded
   publisherFiveWs.witness
   purposeFiveWs.why[x]

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

QualitySpecification
PlanDefinitionAct[classCode=GROUPER;moodCode=DEFN]
   meta
      idn/a
      extensionn/a
   textAct.text?
   containedN/A
   modifierExtensionN/A
   url.identifier[scope=BUSN;reliability=ISS]
   identifier.identifier
   versionN/A (to add?)
   versionAlgorithm[x]N/A (to add?)
   nameN/A (to add?)
   title.title
   subtitleN/A
   typeN/A (to add?)
      idn/a
      extensionn/a
      codingunion(., ./translation)
      coding (DefinitionType)union(., ./translation)
      coding (ApprovalStatus)union(., ./translation)
      text./originalText[mediaType/code="text/plain"]/data
   status.status
   experimentalN/A (to add?)
   subject[x]N/A
   date.participation[typeCode=AUT].time
   publisher.participation[typeCode=AUT].role
   contact.participation[typeCode=CALLBCK].role
   description.text
   useContextN/A (to add?)
   jurisdictionN/A (to add?)
   purpose.reasonCode.text
   usageN/A (to add?)
   copyrightN/A (to add?)
   copyrightLabelN/A (to add?)
   approvalDate.outboundRelationship[typeCode="SUBJ"].act[classCode=CACT;moodCode=EVN;code="approval"].effectiveTime
   lastReviewDate.outboundRelationship[typeCode="SUBJ"; subsetCode="RECENT"].act[classCode=CACT;moodCode=EVN;code="review"].effectiveTime
   effectivePeriodN/A (to add?)
   topicN/A (to add?)
   author.participation[typeCode=AUT]
   editor.participation[typeCode=AUT]
   reviewer.participation[typeCode=VRF] {not clear whether VRF best corresponds to reviewer or endorser}
   endorser.participation[typeCode=VRF] {not clear whether VRF best corresponds to reviewer or endorser}
   relatedArtifact.outboundRelationship[typeCode=DOC,RSON,PREV, DRIV, USE, COMP] {successor would be PREV w/ inversionInd=true; No support for citation}
   libraryN/A (to add?)
   goalN/A (to add?)
      idn/a
      extensionn/a
      modifierExtensionN/A
      categoryN/A (to add?)
      descriptionN/A (to add?)
      priorityN/A (to add?)
      startN/A (to add?)
      addressesN/A (to add?)
         idn/a
         extensionn/a
         codingunion(., ./translation)
            idn/a
            extensionn/a
            system./codeSystem
            version./codeSystemVersion
            code./code
            displayCV.displayName
            userSelectedCD.codingRationale
         text./originalText[mediaType/code="text/plain"]/data
      documentationN/A (to add?)
         idn/a
         extensionn/a
      targetN/A (to add?)
         idn/a
         extensionn/a
         modifierExtensionN/A
         measureN/A (to add?)
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         detail[x]N/A (to add?)
         detail[x] (detailQuantity)N/A (to add?)
            idn/a
            extension
            extension (interpretationCode)
               idn/a
               urlN/A
               value[x]N/A
            valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
            comparatorIVL properties
            unitPQ.unit
            systemCO.codeSystem, PQ.translation.codeSystem
            codePQ.code, MO.currency, PQ.translation.code
         detail[x] (detailRange)N/A (to add?)
            idn/a
            extensionn/a
            low./low
               idn/a
               extension
               extension (interpretationCodeLow)
                  idn/a
                  urlN/A
                  value[x]N/A
               valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
               unitPQ.unit
               systemCO.codeSystem, PQ.translation.codeSystem
               codePQ.code, MO.currency, PQ.translation.code
            high./high
               idn/a
               extension
               extension (interpretationCodeHigh)
                  idn/a
                  urlN/A
                  value[x]N/A
               valuePQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value
               unitPQ.unit
               systemCO.codeSystem, PQ.translation.codeSystem
               codePQ.code, MO.currency, PQ.translation.code
         detail[x] (detailCodeableConcept)N/A (to add?)
            idn/a
            extensionn/a
            codingunion(., ./translation)
            text./originalText[mediaType/code="text/plain"]/data
         detail[x] (detailInteger)N/A (to add?)
   actor.participation[typeCode=PFM]
      idn/a
      extensionn/a
      modifierExtensionN/A
      titleN/A (to add?)
      descriptionN/A (to add?)
      optionN/A (to add?)
         idn/a
         extensionn/a
         modifierExtensionN/A
         type.role.classCode
         typeCanonical.role.classCode
         typeReference.role.classCode
         roleN/A (to add?)
   actionAct[classCode=ACT; moodCode=DEFN]
      idn/a
      extension
      extension (testOrder)
         idn/a
         urlN/A
         value[x]N/A
      modifierExtensionN/A
      linkIdN/A (to add?)
      prefixN/A (to add?)
      title.title
      description.text
      textEquivalent.text
      priority.priority
      code.classCode
         idn/a
         extensionn/a
         codingunion(., ./translation)
            idn/a
            extensionn/a
            system./codeSystem
            version./codeSystemVersion
            code./code
            displayCV.displayName
            userSelectedCD.codingRationale
         text./originalText[mediaType/code="text/plain"]/data
      reason.reasonCode
         idn/a
         codingunion(., ./translation)
            idn/a
            extensionn/a
            system./codeSystem
            version./codeSystemVersion
            code./code
            displayCV.displayName
            userSelectedCD.codingRationale
         text./originalText[mediaType/code="text/plain"]/data
      documentationN/A (to add?)
         idn/a
         extensionn/a
      goalIdN/A (to add?)
      subject[x]N/A (to add?)
      triggerN/A (to add?)
      conditionN/A (to add?)
         idn/a
         extensionn/a
         modifierExtensionN/A
         kindN/A (to add?)
         expressionN/A (to add?)
      inputN/A (to add?)
         idn/a
         extensionn/a
         modifierExtensionN/A
         titleN/A (to add?)
         requirementN/A (to add?)
         relatedDataN/A (to add?)
      outputN/A (to add?)
         idn/a
         extensionn/a
         modifierExtensionN/A
         titleN/A (to add?)
         requirementN/A (to add?)
         relatedDataN/A (to add?)
      relatedActionN/A (to add?)
         idn/a
         extensionn/a
         modifierExtensionN/A
         targetIdN/A (to add?)
         relationshipN/A (to add?)
         endRelationshipN/A (to add?)
         offset[x]N/A (to add?)
      timing[x].effectiveTime
      location.participation[typeCode=LOC].role
      participant.participation[typeCode=PFM]
         idn/a
         extensionn/a
         modifierExtensionN/A
         actorIdN/A (to add?)
         type.role.classCode
         typeCanonical.role.classCode
         typeReference.role.classCode
         role.role.code
         function.role.code
      type.moodCode { Maybe? this is effectively Create, Update, or Delete }
      groupingBehaviorN/A
      selectionBehaviorN/A
      requiredBehaviorN/A
      precheckBehaviorN/A
      cardinalityBehaviorN/A
      definition[x]Act[classCode=ACT; moodCode=DEFN]
      transformN/A
      dynamicValueN/A
         idn/a
         extensionn/a
         modifierExtensionN/A
         pathN/A
         expressionN/A
      actionN/A
         idn/a
         extension
         extension (stageOrder)
            idn/a
            urlN/A
            value[x]N/A
         modifierExtensionN/A
         linkIdN/A (to add?)
         prefixN/A (to add?)
         title.title
         description.text
         textEquivalent.text
         priority.priority
         code.classCode
         reason.reasonCode
         documentationN/A (to add?)
            idn/a
            extensionn/a
            document
               idn/a
               extensionn/a
               contentType./mediaType, ./charset
               language./language
               data./data
               url./reference/literal
               sizeN/A (needs data type R3 proposal)
               hash.integrityCheck[parent::ED/integrityCheckAlgorithm="SHA-1"]
               title./title/data
               creationN/A (needs data type R3 proposal)
               height.outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value
               width.outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value
               frames.outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value
               duration.outboundRelationship[typeCode="COMP].target[classCode="OBS", moodCode="EVN",code="<CODE>"].value
         goalIdN/A (to add?)
         subject[x]N/A (to add?)
         triggerN/A (to add?)
         conditionN/A (to add?)
            idn/a
            extensionn/a
            modifierExtensionN/A
            kindN/A (to add?)
            expressionN/A (to add?)
         inputN/A (to add?)
            idn/a
            extensionn/a
            modifierExtensionN/A
            titleN/A (to add?)
            requirementN/A (to add?)
            relatedDataN/A (to add?)
         outputN/A (to add?)
            idn/a
            extensionn/a
            modifierExtensionN/A
            titleN/A (to add?)
            requirementN/A (to add?)
            relatedDataN/A (to add?)
         relatedActionN/A (to add?)
            idn/a
            extensionn/a
            modifierExtensionN/A
            targetIdN/A (to add?)
            relationshipN/A (to add?)
            endRelationshipN/A (to add?)
            offset[x]N/A (to add?)
         timing[x].effectiveTime
         location.participation[typeCode=LOC].role
         participant.participation[typeCode=PFM]
            idn/a
            extensionn/a
            modifierExtensionN/A
            actorIdN/A (to add?)
            type.role.classCode
            typeCanonical.role.classCode
            typeReference.role.classCode
            role.role.code
            function.role.code
         type.moodCode { Maybe? this is effectively Create, Update, or Delete }
         groupingBehaviorN/A
         selectionBehaviorN/A
         requiredBehaviorN/A
         precheckBehaviorN/A
         cardinalityBehaviorN/A
         definition[x]Act[classCode=ACT; moodCode=DEFN]
         transformN/A
         dynamicValueN/A
            idn/a
            extensionn/a
            modifierExtensionN/A
            pathN/A
            expressionN/A
         actionN/A
            idn/a
            extension
            extension (testOrder)
               idn/a
               urlN/A
               value[x]N/A
            modifierExtensionN/A
            linkIdN/A (to add?)
            prefixN/A (to add?)
            title.title
            description.text
            textEquivalent.text
            priority.priority
            code.classCode
            reason.reasonCode
            documentationN/A (to add?)
            goalIdN/A (to add?)
            subject[x]N/A (to add?)
            triggerN/A (to add?)
            conditionN/A (to add?)
               idn/a
               extensionn/a
               modifierExtensionN/A
               kindN/A (to add?)
               expressionN/A (to add?)
            inputN/A (to add?)
               idn/a
               extensionn/a
               modifierExtensionN/A
               titleN/A (to add?)
               requirementN/A (to add?)
               relatedDataN/A (to add?)
            outputN/A (to add?)
               idn/a
               extensionn/a
               modifierExtensionN/A
               titleN/A (to add?)
               requirementN/A (to add?)
               relatedDataN/A (to add?)
            relatedActionN/A (to add?)
               idn/a
               extensionn/a
               modifierExtensionN/A
               targetIdN/A (to add?)
               relationshipN/A (to add?)
               endRelationshipN/A (to add?)
               offset[x]N/A (to add?)
            timing[x].effectiveTime
            location.participation[typeCode=LOC].role
            participant.participation[typeCode=PFM]
               idn/a
               extensionn/a
               modifierExtensionN/A
               actorIdN/A (to add?)
               type.role.classCode
               typeCanonical.role.classCode
               typeReference.role.classCode
               role.role.code
               function.role.code
            type.moodCode { Maybe? this is effectively Create, Update, or Delete }
            groupingBehaviorN/A
            selectionBehaviorN/A
            requiredBehaviorN/A
            precheckBehaviorN/A
            cardinalityBehaviorN/A
            definition[x]Act[classCode=ACT; moodCode=DEFN]
            transformN/A
            dynamicValueN/A
               idn/a
               extensionn/a
               modifierExtensionN/A
               pathN/A
               expressionN/A
            actionN/A
   asNeeded[x]boolean: precondition.negationInd (inversed - so negationInd = true means asNeeded=false CodeableConcept: precondition.observationEventCriterion[code="Assertion"].value

Mappings for Object Implementation Information (http://hl7.org/fhir/object-implementation)

QualitySpecification
PlanDefinition
   identifierno-gen-base
   versionno-gen-base
   versionAlgorithm[x]no-gen-base
   purposeno-gen-base
   copyrightno-gen-base
   copyrightLabelno-gen-base
   approvalDateno-gen-base
   lastReviewDateno-gen-base
   effectivePeriodno-gen-base