Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon 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 1.1.6 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: eCTD Substance Characterisation

Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s3 Version: 1.1.6
Active as of 2024-09-22 Computable Name: EctdComposition32S3
Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.40

The fields needed to represent the Substance Structure and Impurities to be included under the 3.2.S.3 heading of the eCTD. References Sponsor Organization, Drug Substance Structure, and Drug Substance Impurities

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

This structure is derived from Composition

NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition Composition
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier S 0..1 Identifier Version-independent identifier for the Composition
... status 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Required Pattern: final
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S3
..... display 1..1 string Representation defined by the system
Fixed Value: Substance Characterisation
... author S 1..1 Reference(Basic Organization) Who and/or what authored the composition
... title S 1..1 string Human Readable name/title
... Slices for section S 1..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code
.... section:All Slices Content/Rules for all slices
..... entry S 0..* Reference(Resource) A reference to data that supports this section
.... section:Structure S 1..1 BackboneElement Composition is broken into sections
..... title S 1..1 string Label for section (e.g. for ToC)
..... code S 1..1 CodeableConcept Classification of section (recommended)
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S31
....... display 1..1 string Representation defined by the system
Fixed Value: Substance Elucidation of Structure and other Characteristics
..... entry 1..1 Reference(Drug Substance) A reference to data that supports this section

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 0..1 Identifier Version-independent identifier for the Composition
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.


Required Pattern: final
... type Σ 1..1 CodeableConcept Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.


Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S3
..... display 1..1 string Representation defined by the system
Fixed Value: Substance Characterisation
... date Σ 1..1 dateTime Composition editing time
... author SΣ 1..1 Reference(Basic Organization) Who and/or what authored the composition
... title SΣ 1..1 string Human Readable name/title
... Slices for section SC 1..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code
cmp-1: A section must contain at least one of text, entries, or sub-sections
cmp-2: A section can only have an emptyReason if it is empty
.... section:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... entry SC 0..* Reference(Resource) A reference to data that supports this section
.... section:Structure SC 1..1 BackboneElement Composition is broken into sections
cmp-1: A section must contain at least one of text, entries, or sub-sections
cmp-2: A section can only have an emptyReason if it is empty
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title S 1..1 string Label for section (e.g. for ToC)
..... code S 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S31
....... display 1..1 string Representation defined by the system
Fixed Value: Substance Elucidation of Structure and other Characteristics
..... entry C 1..1 Reference(Drug Substance) A reference to data that supports this section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.statusrequiredPattern: final
http://hl7.org/fhir/ValueSet/composition-status|5.0.0
from the FHIR Standard
Composition.typepreferredPattern: 32S3("Substance Characterisation")
http://hl7.org/fhir/ValueSet/doc-typecodes
from the FHIR Standard
Composition.section:Structure.codeexamplePattern: 32S31("Substance Elucidation of Structure and other Characteristics")
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.section, Composition.section:StructureA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.section, Composition.section:StructureA section can only have an emptyReason if it is empty
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorCompositionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url Σ 0..1 uri Canonical identifier for this Composition, represented as a URI (globally unique)
... identifier SΣ 0..1 Identifier Version-independent identifier for the Composition
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the Composition
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.


Required Pattern: final
... type Σ 1..1 CodeableConcept Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.


Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S3
..... display 1..1 string Representation defined by the system
Fixed Value: Substance Characterisation
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... category Σ 0..* CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.


... subject Σ 0..* Reference(Resource) Who and/or what the composition is about
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Composition editing time
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author SΣ 1..1 Reference(Basic Organization) Who and/or what authored the composition
... name Σ 0..1 string Name for this Composition (computer friendly)
... title SΣ 1..1 string Human Readable name/title
... note 0..* Annotation For any additional notes
... attester 0..* BackboneElement Attests to accuracy of composition
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... mode 1..1 CodeableConcept personal | professional | legal | official
Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.

.... time 0..1 dateTime When the composition was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) Who attested the composition
... custodian Σ 0..1 Reference(Organization) Organization which maintains the composition
... relatesTo 0..* RelatedArtifact Relationships to other compositions/documents
... event Σ 0..* BackboneElement The clinical service(s) being documented
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... period Σ 0..1 Period The period covered by the documentation
.... detail Σ 0..* CodeableReference(Resource) The event(s) being documented, as code(s), reference(s), or both
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.


... Slices for section SC 1..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code
cmp-1: A section must contain at least one of text, entries, or sub-sections
cmp-2: A section can only have an emptyReason if it is empty
.... section:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

..... author 0..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry SC 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section 0..* See section (Composition) Nested Section
.... section:Structure SC 1..1 BackboneElement Composition is broken into sections
cmp-1: A section must contain at least one of text, entries, or sub-sections
cmp-2: A section can only have an emptyReason if it is empty
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title S 1..1 string Label for section (e.g. for ToC)
..... code S 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S31
....... display 1..1 string Representation defined by the system
Fixed Value: Substance Elucidation of Structure and other Characteristics
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... author 0..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry C 1..1 Reference(Drug Substance) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section 0..* See section (Composition) Nested Section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Composition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Composition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Composition.statusrequiredPattern: final
http://hl7.org/fhir/ValueSet/composition-status|5.0.0
from the FHIR Standard
Composition.typepreferredPattern: 32S3("Substance Characterisation")
http://hl7.org/fhir/ValueSet/doc-typecodes
from the FHIR Standard
Composition.categoryexampleReferencedItemCategoryValueSet
http://hl7.org/fhir/ValueSet/referenced-item-category
from the FHIR Standard
Composition.attester.modepreferredCompositionAttestationMode
http://hl7.org/fhir/ValueSet/composition-attestation-mode
from the FHIR Standard
Composition.event.detailexampleActCode
http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard
Composition.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
from the FHIR Standard
Composition.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
from the FHIR Standard
Composition.section:Structure.codeexamplePattern: 32S31("Substance Elucidation of Structure and other Characteristics")
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard
Composition.section:Structure.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
from the FHIR Standard
Composition.section:Structure.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.section, Composition.section:StructureA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.section, Composition.section:StructureA section can only have an emptyReason if it is empty
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorCompositionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Composition

Summary

Mandatory: 5 elements
Must-Support: 9 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Composition.section

Differential View

This structure is derived from Composition

NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition Composition
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... identifier S 0..1 Identifier Version-independent identifier for the Composition
... status 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Required Pattern: final
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S3
..... display 1..1 string Representation defined by the system
Fixed Value: Substance Characterisation
... author S 1..1 Reference(Basic Organization) Who and/or what authored the composition
... title S 1..1 string Human Readable name/title
... Slices for section S 1..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code
.... section:All Slices Content/Rules for all slices
..... entry S 0..* Reference(Resource) A reference to data that supports this section
.... section:Structure S 1..1 BackboneElement Composition is broken into sections
..... title S 1..1 string Label for section (e.g. for ToC)
..... code S 1..1 CodeableConcept Classification of section (recommended)
Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S31
....... display 1..1 string Representation defined by the system
Fixed Value: Substance Elucidation of Structure and other Characteristics
..... entry 1..1 Reference(Drug Substance) A reference to data that supports this section

doco Documentation for this format

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... contained 0..* Resource Contained, inline Resources
... identifier SΣ 0..1 Identifier Version-independent identifier for the Composition
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.


Required Pattern: final
... type Σ 1..1 CodeableConcept Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.


Required Pattern: At least the following
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S3
..... display 1..1 string Representation defined by the system
Fixed Value: Substance Characterisation
... date Σ 1..1 dateTime Composition editing time
... author SΣ 1..1 Reference(Basic Organization) Who and/or what authored the composition
... title SΣ 1..1 string Human Readable name/title
... Slices for section SC 1..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code
cmp-1: A section must contain at least one of text, entries, or sub-sections
cmp-2: A section can only have an emptyReason if it is empty
.... section:All Slices Content/Rules for all slices
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... entry SC 0..* Reference(Resource) A reference to data that supports this section
.... section:Structure SC 1..1 BackboneElement Composition is broken into sections
cmp-1: A section must contain at least one of text, entries, or sub-sections
cmp-2: A section can only have an emptyReason if it is empty
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title S 1..1 string Label for section (e.g. for ToC)
..... code S 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S31
....... display 1..1 string Representation defined by the system
Fixed Value: Substance Elucidation of Structure and other Characteristics
..... entry C 1..1 Reference(Drug Substance) A reference to data that supports this section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.statusrequiredPattern: final
http://hl7.org/fhir/ValueSet/composition-status|5.0.0
from the FHIR Standard
Composition.typepreferredPattern: 32S3("Substance Characterisation")
http://hl7.org/fhir/ValueSet/doc-typecodes
from the FHIR Standard
Composition.section:Structure.codeexamplePattern: 32S31("Substance Elucidation of Structure and other Characteristics")
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.section, Composition.section:StructureA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.section, Composition.section:StructureA section can only have an emptyReason if it is empty
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorCompositionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. Composition 0..* Composition A set of resources composed into a single coherent clinical statement with clinical attestation
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 id Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: AllSecurityLabels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.


.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".


... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter Set
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 0..* Extension Additional content defined by implementations
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... url Σ 0..1 uri Canonical identifier for this Composition, represented as a URI (globally unique)
... identifier SΣ 0..1 Identifier Version-independent identifier for the Composition
... version Σ 0..1 string An explicitly assigned identifer of a variation of the content in the Composition
... status ?!Σ 1..1 code registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown
Binding: CompositionStatus (required): The workflow/clinical status of the composition.


Required Pattern: final
... type Σ 1..1 CodeableConcept Kind of composition (LOINC if possible)
Binding: FHIRDocumentTypeCodes (preferred): Type of a composition.


Required Pattern: At least the following
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
..... version 0..1 string Version of the system - if relevant
..... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S3
..... display 1..1 string Representation defined by the system
Fixed Value: Substance Characterisation
..... userSelected 0..1 boolean If this coding was chosen directly by the user
.... text 0..1 string Plain text representation of the concept
... category Σ 0..* CodeableConcept Categorization of Composition
Binding: ReferencedItemCategoryValueSet (example): High-level kind of a clinical document at a macro level.


... subject Σ 0..* Reference(Resource) Who and/or what the composition is about
... encounter Σ 0..1 Reference(Encounter) Context of the Composition
... date Σ 1..1 dateTime Composition editing time
... useContext Σ 0..* UsageContext The context that the content is intended to support
... author SΣ 1..1 Reference(Basic Organization) Who and/or what authored the composition
... name Σ 0..1 string Name for this Composition (computer friendly)
... title SΣ 1..1 string Human Readable name/title
... note 0..* Annotation For any additional notes
... attester 0..* BackboneElement Attests to accuracy of composition
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... mode 1..1 CodeableConcept personal | professional | legal | official
Binding: CompositionAttestationMode (preferred): The way in which a person authenticated a composition.

.... time 0..1 dateTime When the composition was attested
.... party 0..1 Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) Who attested the composition
... custodian Σ 0..1 Reference(Organization) Organization which maintains the composition
... relatesTo 0..* RelatedArtifact Relationships to other compositions/documents
... event Σ 0..* BackboneElement The clinical service(s) being documented
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... period Σ 0..1 Period The period covered by the documentation
.... detail Σ 0..* CodeableReference(Resource) The event(s) being documented, as code(s), reference(s), or both
Binding: v3 Code System ActCode (example): This list of codes represents the main clinical acts being documented.


... Slices for section SC 1..* BackboneElement Composition is broken into sections
Slice: Unordered, Open by value:code
cmp-1: A section must contain at least one of text, entries, or sub-sections
cmp-2: A section can only have an emptyReason if it is empty
.... section:All Slices Content/Rules for all slices
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title 0..1 string Label for section (e.g. for ToC)
..... code 0..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.

..... author 0..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry SC 0..* Reference(Resource) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section 0..* See section (Composition) Nested Section
.... section:Structure SC 1..1 BackboneElement Composition is broken into sections
cmp-1: A section must contain at least one of text, entries, or sub-sections
cmp-2: A section can only have an emptyReason if it is empty
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... title S 1..1 string Label for section (e.g. for ToC)
..... code S 1..1 CodeableConcept Classification of section (recommended)
Binding: DocumentSectionCodes (example): Classification of a section of a composition/document.


Required Pattern: At least the following
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... system 1..1 uri Identity of the terminology system
Fixed Value: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types
....... version 0..1 string Version of the system - if relevant
....... code 1..1 code Symbol in syntax defined by the system
Fixed Value: 32S31
....... display 1..1 string Representation defined by the system
Fixed Value: Substance Elucidation of Structure and other Characteristics
....... userSelected 0..1 boolean If this coding was chosen directly by the user
...... text 0..1 string Plain text representation of the concept
..... author 0..* Reference(Practitioner | PractitionerRole | Device | Patient | RelatedPerson | Organization) Who and/or what authored the section
..... focus 0..1 Reference(Resource) Who/what the section is about, when it is not about the subject of composition
..... text C 0..1 Narrative Text summary of the section, for human interpretation
..... orderedBy 0..1 CodeableConcept Order of section entries
Binding: ListOrderCodes (preferred): What order applies to the items in the entry.

..... entry C 1..1 Reference(Drug Substance) A reference to data that supports this section
..... emptyReason C 0..1 CodeableConcept Why the section is empty
Binding: ListEmptyReasons (preferred): If a section is empty, why it is empty.

..... section 0..* See section (Composition) Nested Section

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
Composition.meta.securityextensibleAllSecurityLabels
http://hl7.org/fhir/ValueSet/security-labels
from the FHIR Standard
Composition.meta.tagexampleCommonTags
http://hl7.org/fhir/ValueSet/common-tags
from the FHIR Standard
Composition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
Composition.statusrequiredPattern: final
http://hl7.org/fhir/ValueSet/composition-status|5.0.0
from the FHIR Standard
Composition.typepreferredPattern: 32S3("Substance Characterisation")
http://hl7.org/fhir/ValueSet/doc-typecodes
from the FHIR Standard
Composition.categoryexampleReferencedItemCategoryValueSet
http://hl7.org/fhir/ValueSet/referenced-item-category
from the FHIR Standard
Composition.attester.modepreferredCompositionAttestationMode
http://hl7.org/fhir/ValueSet/composition-attestation-mode
from the FHIR Standard
Composition.event.detailexampleActCode
http://terminology.hl7.org/ValueSet/v3-ActCode
Composition.section.codeexampleDocumentSectionCodes
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard
Composition.section.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
from the FHIR Standard
Composition.section.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
from the FHIR Standard
Composition.section:Structure.codeexamplePattern: 32S31("Substance Elucidation of Structure and other Characteristics")
http://hl7.org/fhir/ValueSet/doc-section-codes
from the FHIR Standard
Composition.section:Structure.orderedBypreferredListOrderCodes
http://hl7.org/fhir/ValueSet/list-order
from the FHIR Standard
Composition.section:Structure.emptyReasonpreferredListEmptyReasons
http://hl7.org/fhir/ValueSet/list-empty-reason
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
cmp-1errorComposition.section, Composition.section:StructureA section must contain at least one of text, entries, or sub-sections
: text.exists() or entry.exists() or section.exists()
cmp-2errorComposition.section, Composition.section:StructureA section can only have an emptyReason if it is empty
: emptyReason.empty() or entry.empty()
dom-2errorCompositionIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorCompositionIf the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
: contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4errorCompositionIf a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
: contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5errorCompositionIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceCompositionA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from Composition

Summary

Mandatory: 5 elements
Must-Support: 9 elements

Structures

This structure refers to these other structures:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of Composition.section

 

Other representations of profile: CSV, Excel, Schematron