Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2

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 2.0.0 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: 2.0.0
Standards status: Trial-use | Maturity Level: 2 | 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

Usages:

- Use this Profile: CMC eCTD 32S3 Document

### Formal Views of Profile Content

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

- Key Elements Table
- Differential Table
- Snapshot Table
- Statistics/References
- All

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 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
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://terminology.hl7.org/CodeSystem/ICHContextOfUse
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3 characterisation
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
date | Σ | 1..1 | dateTime | Composition editing time
author | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition
title | S Σ | 1..1 | string | Human Readable name/title
Slices for section | S C | 1..* | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code Constraints: cmp-1, cmp-2
section:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
entry | C | 0..* | Reference(Resource) | A reference to data that supports this section
section:Structure | S C | 1..1 | BackboneElement | Composition is broken into sections Constraints: cmp-1, cmp-2
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://terminology.hl7.org/CodeSystem/ICHContextOfUse
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3.1
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3.1 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
entry | S C | 1..1 | LiteralReference(Drug Substance) {b} | A reference to data that supports this section
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Composition.status | required | Pattern Value: final `http://hl7.org/fhir/ValueSet/composition-status|5.0.0` From the FHIR Standard
Composition.type | preferred | Pattern Value: ich_3.2.s.3("m3.2.s.3 characterisation") `http://hl7.org/fhir/ValueSet/doc-typecodes` From the FHIR Standard
Composition.section:Structure.code | example | Pattern Value: ich_3.2.s.3.1("m3.2.s.3.1 elucidation of structure and other characteristics") `http://hl7.org/fhir/ValueSet/doc-section-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmp-1 | error | Composition.section, Composition.section:Structure | A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists() |
cmp-2 | error | Composition.section, Composition.section:Structure | A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty() |
dom-2 | error | Composition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Composition | If 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-4 | error | Composition | If 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-5 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Composition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from Composition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  |  | Composition |
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
type |  | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) 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://terminology.hl7.org/CodeSystem/ICHContextOfUse
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3 characterisation
author | S | 1..1 | LiteralReference(Basic Organization) {b} | 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: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://terminology.hl7.org/CodeSystem/ICHContextOfUse
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3.1
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3.1 elucidation of structure and other characteristics
entry | S | 1..1 | LiteralReference(Drug Substance) {b} | A reference to data that supports this section
Documentation for this format

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
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 Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 | S Σ | 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://terminology.hl7.org/CodeSystem/ICHContextOfUse
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3 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 | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition
name | Σ | 0..1 | string | Name for this Composition (computer friendly)
title | S Σ | 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 | S C | 1..* | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code Constraints: cmp-1, cmp-2
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy |  | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry | C | 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 | S C | 1..1 | BackboneElement | Composition is broken into sections Constraints: cmp-1, cmp-2
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://terminology.hl7.org/CodeSystem/ICHContextOfUse
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3.1
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3.1 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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy |  | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry | S C | 1..1 | LiteralReference(Drug Substance) {b} | 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
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Composition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
Composition.status | required | Pattern Value: final `http://hl7.org/fhir/ValueSet/composition-status|5.0.0` From the FHIR Standard
Composition.type | preferred | Pattern Value: ich_3.2.s.3("m3.2.s.3 characterisation") `http://hl7.org/fhir/ValueSet/doc-typecodes` From the FHIR Standard
Composition.category | example | ReferencedItemCategoryValueSet `http://hl7.org/fhir/ValueSet/referenced-item-category` From the FHIR Standard
Composition.attester.mode | preferred | CompositionAttestationMode `http://hl7.org/fhir/ValueSet/composition-attestation-mode` From the FHIR Standard
Composition.event.detail | example | ActCode `http://terminology.hl7.org/ValueSet/v3-ActCode`
Composition.section.code | example | DocumentSectionCodes `http://hl7.org/fhir/ValueSet/doc-section-codes` From the FHIR Standard
Composition.section.orderedBy | preferred | ListOrderCodes `http://hl7.org/fhir/ValueSet/list-order` From the FHIR Standard
Composition.section.emptyReason | preferred | ListEmptyReasons `http://hl7.org/fhir/ValueSet/list-empty-reason` From the FHIR Standard
Composition.section:Structure.code | example | Pattern Value: ich_3.2.s.3.1("m3.2.s.3.1 elucidation of structure and other characteristics") `http://hl7.org/fhir/ValueSet/doc-section-codes` From the FHIR Standard
Composition.section:Structure.orderedBy | preferred | ListOrderCodes `http://hl7.org/fhir/ValueSet/list-order` From the FHIR Standard
Composition.section:Structure.emptyReason | preferred | ListEmptyReasons `http://hl7.org/fhir/ValueSet/list-empty-reason` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmp-1 | error | Composition.section, Composition.section:Structure | A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists() |
cmp-2 | error | Composition.section, Composition.section:Structure | A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty() |
dom-2 | error | Composition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Composition | If 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-4 | error | Composition | If 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-5 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Composition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from Composition

Summary

Mandatory: 5 elements
Must-Support: 8 elements

Structures

This structure refers to these other structures:

- Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
- Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
- Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-characterisation)

Slices

This structure defines the following Slices:

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

Maturity: 2

Key Elements View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation
implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created
contained |  | 0..* | Resource | Contained, inline Resources
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored
identifier | S Σ | 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
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://terminology.hl7.org/CodeSystem/ICHContextOfUse
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3 characterisation
userSelected |  | 0..1 | boolean | If this coding was chosen directly by the user
text |  | 0..1 | string | Plain text representation of the concept
date | Σ | 1..1 | dateTime | Composition editing time
author | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition
title | S Σ | 1..1 | string | Human Readable name/title
Slices for section | S C | 1..* | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code Constraints: cmp-1, cmp-2
section:All Slices |  |  |  | Content/Rules for all slices
modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized
entry | C | 0..* | Reference(Resource) | A reference to data that supports this section
section:Structure | S C | 1..1 | BackboneElement | Composition is broken into sections Constraints: cmp-1, cmp-2
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://terminology.hl7.org/CodeSystem/ICHContextOfUse
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3.1
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3.1 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
entry | S C | 1..1 | LiteralReference(Drug Substance) {b} | A reference to data that supports this section
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Composition.status | required | Pattern Value: final `http://hl7.org/fhir/ValueSet/composition-status|5.0.0` From the FHIR Standard
Composition.type | preferred | Pattern Value: ich_3.2.s.3("m3.2.s.3 characterisation") `http://hl7.org/fhir/ValueSet/doc-typecodes` From the FHIR Standard
Composition.section:Structure.code | example | Pattern Value: ich_3.2.s.3.1("m3.2.s.3.1 elucidation of structure and other characteristics") `http://hl7.org/fhir/ValueSet/doc-section-codes` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmp-1 | error | Composition.section, Composition.section:Structure | A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists() |
cmp-2 | error | Composition.section, Composition.section:Structure | A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty() |
dom-2 | error | Composition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Composition | If 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-4 | error | Composition | If 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-5 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Composition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

Differential View

This structure is derived from Composition

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
Composition |  |  | Composition |
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
type |  | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) 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://terminology.hl7.org/CodeSystem/ICHContextOfUse
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3 characterisation
author | S | 1..1 | LiteralReference(Basic Organization) {b} | 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: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://terminology.hl7.org/CodeSystem/ICHContextOfUse
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3.1
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3.1 elucidation of structure and other characteristics
entry | S | 1..1 | LiteralReference(Drug Substance) {b} | A reference to data that supports this section
Documentation for this format

Snapshot View

Name | Flags | Card. | Type | Description & Constraints Filter: Bindings Constraints Obligations
--- | --- | --- | --- | ---
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
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 Bindings | Purpose
CommonLanguages | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements
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 | S Σ | 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://terminology.hl7.org/CodeSystem/ICHContextOfUse
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3 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 | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition
name | Σ | 0..1 | string | Name for this Composition (computer friendly)
title | S Σ | 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 | S C | 1..* | BackboneElement | Composition is broken into sections Slice: Unordered, Open by value:code Constraints: cmp-1, cmp-2
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy |  | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry | C | 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 | S C | 1..1 | BackboneElement | Composition is broken into sections Constraints: cmp-1, cmp-2
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://terminology.hl7.org/CodeSystem/ICHContextOfUse
version |  | 0..1 | string | Version of the system - if relevant
code |  | 1..1 | code | Symbol in syntax defined by the system Fixed Value: ich_3.2.s.3.1
display |  | 1..1 | string | Representation defined by the system Fixed Value: m3.2.s.3.1 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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
orderedBy |  | 0..1 | CodeableConcept | Order of section entries Binding: ListOrderCodes (preferred): What order applies to the items in the entry.
entry | S C | 1..1 | LiteralReference(Drug Substance) {b} | 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
Documentation for this format

#### Terminology Bindings

Path | Conformance | ValueSet / Code | URI
Composition.language | required | AllLanguages `http://hl7.org/fhir/ValueSet/all-languages|5.0.0` From the FHIR Standard
Composition.status | required | Pattern Value: final `http://hl7.org/fhir/ValueSet/composition-status|5.0.0` From the FHIR Standard
Composition.type | preferred | Pattern Value: ich_3.2.s.3("m3.2.s.3 characterisation") `http://hl7.org/fhir/ValueSet/doc-typecodes` From the FHIR Standard
Composition.category | example | ReferencedItemCategoryValueSet `http://hl7.org/fhir/ValueSet/referenced-item-category` From the FHIR Standard
Composition.attester.mode | preferred | CompositionAttestationMode `http://hl7.org/fhir/ValueSet/composition-attestation-mode` From the FHIR Standard
Composition.event.detail | example | ActCode `http://terminology.hl7.org/ValueSet/v3-ActCode`
Composition.section.code | example | DocumentSectionCodes `http://hl7.org/fhir/ValueSet/doc-section-codes` From the FHIR Standard
Composition.section.orderedBy | preferred | ListOrderCodes `http://hl7.org/fhir/ValueSet/list-order` From the FHIR Standard
Composition.section.emptyReason | preferred | ListEmptyReasons `http://hl7.org/fhir/ValueSet/list-empty-reason` From the FHIR Standard
Composition.section:Structure.code | example | Pattern Value: ich_3.2.s.3.1("m3.2.s.3.1 elucidation of structure and other characteristics") `http://hl7.org/fhir/ValueSet/doc-section-codes` From the FHIR Standard
Composition.section:Structure.orderedBy | preferred | ListOrderCodes `http://hl7.org/fhir/ValueSet/list-order` From the FHIR Standard
Composition.section:Structure.emptyReason | preferred | ListEmptyReasons `http://hl7.org/fhir/ValueSet/list-empty-reason` From the FHIR Standard

#### Constraints

Id | Grade | Path(s) | Details | Requirements
cmp-1 | error | Composition.section, Composition.section:Structure | A section must contain at least one of text, entries, or sub-sections : text.exists() or entry.exists() or section.exists() |
cmp-2 | error | Composition.section, Composition.section:Structure | A section can only have an emptyReason if it is empty : emptyReason.empty() or entry.empty() |
dom-2 | error | Composition | If the resource is contained in another resource, it SHALL NOT contain nested Resources : contained.contained.empty() |
dom-3 | error | Composition | If 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-4 | error | Composition | If 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-5 | error | Composition | If a resource is contained in another resource, it SHALL NOT have a security label : contained.meta.security.empty() |
dom-6 | best practice | Composition | A resource should have narrative for robust management : text.`div`.exists() |
ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) |
ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |

This structure is derived from Composition

Summary

Mandatory: 5 elements
Must-Support: 8 elements

Structures

This structure refers to these other structures:

- Literal Reference (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/literal-reference)
- Basic Organization (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization)
- Drug Substance (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-characterisation)

Slices

This structure defines the following Slices:

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

Maturity: 2

Other representations of profile: CSV, Excel, Schematron