Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - 2025Jan
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-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s3 | Version: 2.0.0-ballot | |||
| Active as of 2024-12-04 | 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:
Description of Profiles, Differentials, Snapshots and how the different presentations work.
This structure is derived from Composition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
  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/temporary-uri/codeSystem/ICH-context-of-use | |
| 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: 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/temporary-uri/codeSystem/ICH-context-of-use | |
| 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: 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 |
|---|---|---|---|---|
| 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 |
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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use | |
| 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: Characterisation | |
| date |
Σ | 1..1 | dateTime | Composition editing time |
| author |
SΣ | 1..1 | LiteralReference(Basic Organization) {b} | 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 |
C | 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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use | |
| 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: Elucidation of Structure and other Characteristics | |
| entry |
SC | 1..1 | LiteralReference(Drug Substance) {b} | A reference to data that supports this section |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Composition.status | required | Pattern: finalhttp://hl7.org/fhir/ValueSet/composition-status|5.0.0from the FHIR Standard | |
| Composition.type | preferred | Pattern: ich_3.2.s.3("Characterisation")http://hl7.org/fhir/ValueSet/doc-typecodesfrom the FHIR Standard | |
| Composition.section:Structure.code | example | Pattern: ich_3.2.s.3.1("Elucidation of Structure and other Characteristics")http://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard |
| 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() |
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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
| |||||
| 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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use | |||||
| 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: 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 | LiteralReference(Basic Organization) {b} | 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 |
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 |
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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use | |||||
| 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: 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 |
SC | 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 | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| Composition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Composition.status | required | Pattern: finalhttp://hl7.org/fhir/ValueSet/composition-status|5.0.0from the FHIR Standard | |
| Composition.type | preferred | Pattern: ich_3.2.s.3("Characterisation")http://hl7.org/fhir/ValueSet/doc-typecodesfrom the FHIR Standard | |
| Composition.category | example | ReferencedItemCategoryValueSethttp://hl7.org/fhir/ValueSet/referenced-item-categoryfrom the FHIR Standard | |
| Composition.attester.mode | preferred | CompositionAttestationModehttp://hl7.org/fhir/ValueSet/composition-attestation-modefrom the FHIR Standard | |
| Composition.event.detail | example | ActCodehttp://terminology.hl7.org/ValueSet/v3-ActCode | |
| Composition.section.code | example | DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard | |
| Composition.section.orderedBy | preferred | ListOrderCodeshttp://hl7.org/fhir/ValueSet/list-orderfrom the FHIR Standard | |
| Composition.section.emptyReason | preferred | ListEmptyReasonshttp://hl7.org/fhir/ValueSet/list-empty-reasonfrom the FHIR Standard | |
| Composition.section:Structure.code | example | Pattern: ich_3.2.s.3.1("Elucidation of Structure and other Characteristics")http://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard | |
| Composition.section:Structure.orderedBy | preferred | ListOrderCodeshttp://hl7.org/fhir/ValueSet/list-orderfrom the FHIR Standard | |
| Composition.section:Structure.emptyReason | preferred | ListEmptyReasonshttp://hl7.org/fhir/ValueSet/list-empty-reasonfrom the FHIR Standard |
| 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:
Slices
This structure defines the following Slices:
Differential View
This structure is derived from Composition
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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/temporary-uri/codeSystem/ICH-context-of-use | |
| 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: 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/temporary-uri/codeSystem/ICH-context-of-use | |
| 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: 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 | ||||
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints |
|---|---|---|---|---|
| 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 |
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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use | |
| 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: Characterisation | |
| date |
Σ | 1..1 | dateTime | Composition editing time |
| author |
SΣ | 1..1 | LiteralReference(Basic Organization) {b} | 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 |
C | 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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use | |
| 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: Elucidation of Structure and other Characteristics | |
| entry |
SC | 1..1 | LiteralReference(Drug Substance) {b} | A reference to data that supports this section |
| Documentation for this format | ||||
| Path | Conformance | ValueSet / Code | URI |
| Composition.status | required | Pattern: finalhttp://hl7.org/fhir/ValueSet/composition-status|5.0.0from the FHIR Standard | |
| Composition.type | preferred | Pattern: ich_3.2.s.3("Characterisation")http://hl7.org/fhir/ValueSet/doc-typecodesfrom the FHIR Standard | |
| Composition.section:Structure.code | example | Pattern: ich_3.2.s.3.1("Elucidation of Structure and other Characteristics")http://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard |
| 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() |
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints | ||||
|---|---|---|---|---|---|---|---|---|
| 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
| |||||
| 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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use | |||||
| 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: 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 | LiteralReference(Basic Organization) {b} | 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 |
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 |
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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use | |||||
| 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: 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 |
SC | 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 | ||||||||
| Path | Conformance | ValueSet / Code | URI |
| Composition.language | required | AllLanguageshttp://hl7.org/fhir/ValueSet/all-languages|5.0.0from the FHIR Standard | |
| Composition.status | required | Pattern: finalhttp://hl7.org/fhir/ValueSet/composition-status|5.0.0from the FHIR Standard | |
| Composition.type | preferred | Pattern: ich_3.2.s.3("Characterisation")http://hl7.org/fhir/ValueSet/doc-typecodesfrom the FHIR Standard | |
| Composition.category | example | ReferencedItemCategoryValueSethttp://hl7.org/fhir/ValueSet/referenced-item-categoryfrom the FHIR Standard | |
| Composition.attester.mode | preferred | CompositionAttestationModehttp://hl7.org/fhir/ValueSet/composition-attestation-modefrom the FHIR Standard | |
| Composition.event.detail | example | ActCodehttp://terminology.hl7.org/ValueSet/v3-ActCode | |
| Composition.section.code | example | DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard | |
| Composition.section.orderedBy | preferred | ListOrderCodeshttp://hl7.org/fhir/ValueSet/list-orderfrom the FHIR Standard | |
| Composition.section.emptyReason | preferred | ListEmptyReasonshttp://hl7.org/fhir/ValueSet/list-empty-reasonfrom the FHIR Standard | |
| Composition.section:Structure.code | example | Pattern: ich_3.2.s.3.1("Elucidation of Structure and other Characteristics")http://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard | |
| Composition.section:Structure.orderedBy | preferred | ListOrderCodeshttp://hl7.org/fhir/ValueSet/list-orderfrom the FHIR Standard | |
| Composition.section:Structure.emptyReason | preferred | ListEmptyReasonshttp://hl7.org/fhir/ValueSet/list-empty-reasonfrom the FHIR Standard |
| 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:
Slices
This structure defines the following Slices:
Other representations of profile: CSV, Excel, Schematron
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change