Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2 United States of America flag

Publication Build: This will be filled in by the publication tooling

Resource Profile: QualitySpecification - Mappings

Page standards status: Trial-use Maturity Level: 2

Mappings for the pqcmc-quality-specification resource profile.

Mappings to Structures in this Implementation Guide

No Mappings Found

Mappings to other Structures

No Mappings Found

Other Mappings

NameWorkflow PatternFiveWs Pattern MappingRIM MappingObject Implementation Informationdoco
.. PlanDefinition
Definition
  • conformance.behavior
  • clinical.general
Act[classCode=GROUPER;moodCode=DEFN]
... id
... meta
... implicitRules
... language
... text
Act.text?
... contained
N/A
... Slices for extension
.... extension:ApprovalStatus
.... extension:spec-additional-info
... modifierExtension
N/A
... url
Definition.url
FiveWs.identifier
.identifier[scope=BUSN;reliability=ISS]
... identifier
Definition.identifier
FiveWs.identifier
.identifier
no-gen-base
... version
Definition.version
FiveWs.version
N/A (to add?)
no-gen-base
... versionAlgorithm[x]
Definition.versionAlgorithm
FiveWs.version
N/A (to add?)
no-gen-base
... name
Definition.name
N/A (to add?)
... title
Definition.title
.title
... subtitle
N/A
... type
N/A (to add?)
.... id
n/a
.... extension
n/a
.... Slices for coding
  • union(.
  • ./translation)
..... coding:DefinitionType
  • union(.
  • ./translation)
..... coding:SpecType
  • union(.
  • ./translation)
.... text
./originalText[mediaType/code="text/plain"]/data
... status
Definition.status {different ValueSet}
FiveWs.status
.status
... experimental
Definition.experimental
FiveWs.class
N/A (to add?)
... subject[x]
Definition.subject
N/A
... date
Definition.date
FiveWs.recorded
.participation[typeCode=AUT].time
... publisher
Definition.publisher
FiveWs.witness
.participation[typeCode=AUT].role
... contact
Definition.contact
.participation[typeCode=CALLBCK].role
... description
Definition.description
.text
... useContext
Definition.useContext
N/A (to add?)
... jurisdiction
Definition.jurisdiction
N/A (to add?)
... purpose
Definition.purpose
FiveWs.why[x]
.reasonCode.text
no-gen-base
... usage
N/A (to add?)
... copyright
Definition.copyright
N/A (to add?)
no-gen-base
... copyrightLabel
Definition.copyrightLabel
N/A (to add?)
no-gen-base
... approvalDate
Definition.approvalDate
.outboundRelationship[typeCode="SUBJ"].act[classCode=CACT;moodCode=EVN;code="approval"].effectiveTime
no-gen-base
... lastReviewDate
Definition.lastReviewDate
.outboundRelationship[typeCode="SUBJ"; subsetCode="RECENT"].act[classCode=CACT;moodCode=EVN;code="review"].effectiveTime
no-gen-base
... effectivePeriod
Definition.effectivePeriod
N/A (to add?)
no-gen-base
... topic
Definition.subject[x]
N/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}
... library
N/A (to add?)
... goal
N/A (to add?)
.... id
n/a
.... Slices for extension
..... extension:ac-additional-info
.... modifierExtension
N/A
.... category
N/A (to add?)
.... description
N/A (to add?)
.... priority
N/A (to add?)
.... start
N/A (to add?)
.... addresses
N/A (to add?)
.... documentation
N/A (to add?)
.... target
N/A (to add?)
..... id
n/a
..... extension
n/a
..... Slices for modifierExtension
...... modifierExtension:targetRange
..... measure
N/A (to add?)
..... Slices for detail[x]
N/A (to add?)
...... detail[x]:detailQuantity
N/A (to add?)
....... id
n/a
....... extension
n/a
....... value
  • PQ.value
  • CO.value
  • MO.value
  • IVL.high or IVL.low depending on the value
....... comparator
IVL properties
....... unit
PQ.unit
....... system
  • CO.codeSystem
  • PQ.translation.codeSystem
....... code
  • PQ.code
  • MO.currency
  • PQ.translation.code
...... detail[x]:detailString
N/A (to add?)
...... detail[x]:detailInteger
N/A (to add?)
..... due
N/A (to add?)
... actor
.participation[typeCode=PFM]
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... title
N/A (to add?)
.... description
N/A (to add?)
.... option
N/A (to add?)
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... type
.role.classCode
..... typeCanonical
.role.classCode
..... typeReference
.role.classCode
..... role
N/A (to add?)
... action
{Is a contained Definition}
Act[classCode=ACT; moodCode=DEFN]
.... id
n/a
.... extension
n/a
.... modifierExtension
N/A
.... linkId
N/A (to add?)
.... prefix
N/A (to add?)
.... title
Definition.title
.title
.... description
Definition.description
.text
.... textEquivalent
Definition.description
.text
.... priority
.priority
.... code
.classCode
..... id
n/a
..... extension
n/a
..... coding
  • union(.
  • ./translation)
..... text
./originalText[mediaType/code="text/plain"]/data
.... reason
.reasonCode
..... id
n/a
..... Slices for extension
...... extension:categoryLevel
..... coding
  • union(.
  • ./translation)
..... text
./originalText[mediaType/code="text/plain"]/data
.... documentation
N/A (to add?)
..... id
n/a
..... extension
n/a
..... type
..... classifier
..... label
..... display
..... citation
..... document
..... resource
..... resourceReference
..... publicationStatus
..... publicationDate
.... goalId
N/A (to add?)
.... subject[x]
Definition.subject
N/A (to add?)
.... trigger
N/A (to add?)
.... condition
N/A (to add?)
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... kind
N/A (to add?)
..... expression
N/A (to add?)
.... input
N/A (to add?)
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... title
N/A (to add?)
..... requirement
N/A (to add?)
..... relatedData
N/A (to add?)
.... output
N/A (to add?)
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... title
N/A (to add?)
..... requirement
N/A (to add?)
..... relatedData
N/A (to add?)
.... relatedAction
N/A (to add?)
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... targetId
N/A (to add?)
..... relationship
N/A (to add?)
..... endRelationship
N/A (to add?)
..... offset[x]
N/A (to add?)
.... timing[x]
.effectiveTime
.... location
.participation[typeCode=LOC].role
.... participant
.participation[typeCode=PFM]
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... actorId
N/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 }
.... groupingBehavior
N/A
.... selectionBehavior
N/A
.... requiredBehavior
N/A
.... precheckBehavior
N/A
.... cardinalityBehavior
N/A
.... definition[x]
Act[classCode=ACT; moodCode=DEFN]
.... transform
N/A
.... dynamicValue
N/A
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... path
N/A
..... expression
N/A
.... action
{InverseRelationship of Definition.partOf}
N/A
..... id
n/a
..... extension
n/a
..... modifierExtension
N/A
..... linkId
N/A (to add?)
..... prefix
N/A (to add?)
..... title
Definition.title
.title
..... description
Definition.description
.text
..... textEquivalent
Definition.description
.text
..... priority
.priority
..... code
.classCode
..... reason
.reasonCode
..... documentation
N/A (to add?)
...... id
n/a
...... extension
n/a
...... type
...... classifier
...... label
...... display
...... citation
...... document
....... id
n/a
....... extension
n/a
....... contentType
  • ./mediaType
  • ./charset
....... language
./language
....... data
./data
....... url
./reference/literal
....... size
N/A (needs data type R3 proposal)
....... hash
:ED/integrityCheckAlgorithm="SHA-1"]
....... title
./title/data
....... creation
N/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
....... pages
...... resource
...... resourceReference
...... publicationStatus
...... publicationDate
..... goalId
N/A (to add?)
..... subject[x]
Definition.subject
N/A (to add?)
..... trigger
N/A (to add?)
..... condition
N/A (to add?)
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... kind
N/A (to add?)
...... expression
N/A (to add?)
..... input
N/A (to add?)
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... title
N/A (to add?)
...... requirement
N/A (to add?)
...... relatedData
N/A (to add?)
..... output
N/A (to add?)
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... title
N/A (to add?)
...... requirement
N/A (to add?)
...... relatedData
N/A (to add?)
..... relatedAction
N/A (to add?)
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... targetId
N/A (to add?)
...... relationship
N/A (to add?)
...... endRelationship
N/A (to add?)
...... offset[x]
N/A (to add?)
..... timing[x]
.effectiveTime
..... location
.participation[typeCode=LOC].role
..... participant
.participation[typeCode=PFM]
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... actorId
N/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 }
..... groupingBehavior
N/A
..... selectionBehavior
N/A
..... requiredBehavior
N/A
..... precheckBehavior
N/A
..... cardinalityBehavior
N/A
..... definition[x]
Act[classCode=ACT; moodCode=DEFN]
..... transform
N/A
..... dynamicValue
N/A
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... path
N/A
...... expression
N/A
..... action
{InverseRelationship of Definition.partOf}
N/A
...... id
n/a
...... extension
n/a
...... modifierExtension
N/A
...... linkId
N/A (to add?)
...... prefix
N/A (to add?)
...... title
Definition.title
.title
...... description
Definition.description
.text
...... textEquivalent
Definition.description
.text
...... priority
.priority
...... code
.classCode
...... reason
.reasonCode
...... documentation
N/A (to add?)
...... goalId
N/A (to add?)
...... subject[x]
Definition.subject
N/A (to add?)
...... trigger
N/A (to add?)
...... condition
N/A (to add?)
....... id
n/a
....... extension
n/a
....... modifierExtension
N/A
....... kind
N/A (to add?)
....... expression
N/A (to add?)
...... input
N/A (to add?)
....... id
n/a
....... extension
n/a
....... modifierExtension
N/A
....... title
N/A (to add?)
....... requirement
N/A (to add?)
....... relatedData
N/A (to add?)
...... output
N/A (to add?)
....... id
n/a
....... extension
n/a
....... modifierExtension
N/A
....... title
N/A (to add?)
....... requirement
N/A (to add?)
....... relatedData
N/A (to add?)
...... relatedAction
N/A (to add?)
....... id
n/a
....... extension
n/a
....... modifierExtension
N/A
....... targetId
N/A (to add?)
....... relationship
N/A (to add?)
....... endRelationship
N/A (to add?)
....... offset[x]
N/A (to add?)
...... timing[x]
.effectiveTime
...... location
.participation[typeCode=LOC].role
...... participant
.participation[typeCode=PFM]
....... id
n/a
....... extension
n/a
....... modifierExtension
N/A
....... actorId
N/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 }
...... groupingBehavior
N/A
...... selectionBehavior
N/A
...... requiredBehavior
N/A
...... precheckBehavior
N/A
...... cardinalityBehavior
N/A
...... definition[x]
Act[classCode=ACT; moodCode=DEFN]
...... transform
N/A
...... dynamicValue
N/A
....... id
n/a
....... extension
n/a
....... modifierExtension
N/A
....... path
N/A
....... expression
N/A
...... action
{InverseRelationship of Definition.partOf}
N/A
... asNeeded[x]
precondition.negationInd (inversed - so negationInd = true means asNeeded=false CodeableConcept: precondition.observationEventCriterion[code="Assertion"].value

doco Documentation for this format