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-32p55 | Version: 2.0.0-ballot | |||
| Active as of 2024-12-04 | Computable Name: EctdComposition32P55 | |||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.39 | ||||
The fields needed to represent the Product Characterisation of Impurities in a to be included under the eCTD. References Sponsor Organization and Product Characterisation of 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: 32P55 | |
 display |
1..1 | string | Representation defined by the system Fixed Value: Product Characterisation of Impurities | |
 author |
S | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition |
 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 | |||
  code |
S | 1..1 | CodeableConcept | Classification of section (recommended) |
  section:Characterisation |
S | 1..1 | BackboneElement | Composition is broken into sections |
 title |
S | 1..1 | string | Label for section (e.g. for ToC) |
 code |
0..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.p.5.5 | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Characterisation of Impurities | |
 entry |
S | 1..1 | LiteralReference(Drug Product Impurities) {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: 32P55 | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Characterisation of Impurities | |
| date |
Σ | 1..1 | dateTime | Composition editing time |
| author |
SΣ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition |
| title |
Σ | 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 |
| code |
S | 1..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. |
| entry |
C | 0..* | Reference(Resource) | A reference to data that supports this section |
| section:Characterisation |
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 |
0..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.p.5.5 | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Characterisation of Impurities | |
| entry |
SC | 1..1 | LiteralReference(Drug Product Impurities) {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: 32P55("Product Characterisation of Impurities")http://hl7.org/fhir/ValueSet/doc-typecodesfrom the FHIR Standard | |
| Composition.section.code | example | DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard | |
| Composition.section:Characterisation.code | example | Pattern: ich_3.2.p.5.5("Characterisation of Impurities")http://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| cmp-1 | error | Composition.section, Composition.section:Characterisation | 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:Characterisation | 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: 32P55 | |||||
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Characterisation of Impurities | |||||
| 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 |
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 |
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 |
S | 1..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:Characterisation |
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 |
0..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.p.5.5 | |||||
| display |
1..1 | string | Representation defined by the system Fixed Value: Characterisation of Impurities | |||||
| 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 Product Impurities) {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: 32P55("Product Characterisation of Impurities")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:Characterisation.code | example | Pattern: ich_3.2.p.5.5("Characterisation of Impurities")http://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard | |
| Composition.section:Characterisation.orderedBy | preferred | ListOrderCodeshttp://hl7.org/fhir/ValueSet/list-orderfrom the FHIR Standard | |
| Composition.section:Characterisation.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:Characterisation | 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:Characterisation | 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: 7 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: 32P55 | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Characterisation of Impurities | |
| author |
S | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition |
| 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 | |||
| code |
S | 1..1 | CodeableConcept | Classification of section (recommended) |
| section:Characterisation |
S | 1..1 | BackboneElement | Composition is broken into sections |
| title |
S | 1..1 | string | Label for section (e.g. for ToC) |
| code |
0..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.p.5.5 | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Characterisation of Impurities | |
| entry |
S | 1..1 | LiteralReference(Drug Product Impurities) {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: 32P55 | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Characterisation of Impurities | |
| date |
Σ | 1..1 | dateTime | Composition editing time |
| author |
SΣ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition |
| title |
Σ | 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 |
| code |
S | 1..1 | CodeableConcept | Classification of section (recommended) Binding: DocumentSectionCodes (example): Classification of a section of a composition/document. |
| entry |
C | 0..* | Reference(Resource) | A reference to data that supports this section |
| section:Characterisation |
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 |
0..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.p.5.5 | |
| display |
1..1 | string | Representation defined by the system Fixed Value: Characterisation of Impurities | |
| entry |
SC | 1..1 | LiteralReference(Drug Product Impurities) {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: 32P55("Product Characterisation of Impurities")http://hl7.org/fhir/ValueSet/doc-typecodesfrom the FHIR Standard | |
| Composition.section.code | example | DocumentSectionCodeshttp://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard | |
| Composition.section:Characterisation.code | example | Pattern: ich_3.2.p.5.5("Characterisation of Impurities")http://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard |
| Id | Grade | Path(s) | Details | Requirements |
| cmp-1 | error | Composition.section, Composition.section:Characterisation | 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:Characterisation | 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: 32P55 | |||||
| display |
1..1 | string | Representation defined by the system Fixed Value: Product Characterisation of Impurities | |||||
| 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 |
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 |
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 |
S | 1..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:Characterisation |
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 |
0..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.p.5.5 | |||||
| display |
1..1 | string | Representation defined by the system Fixed Value: Characterisation of Impurities | |||||
| 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 Product Impurities) {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: 32P55("Product Characterisation of Impurities")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:Characterisation.code | example | Pattern: ich_3.2.p.5.5("Characterisation of Impurities")http://hl7.org/fhir/ValueSet/doc-section-codesfrom the FHIR Standard | |
| Composition.section:Characterisation.orderedBy | preferred | ListOrderCodeshttp://hl7.org/fhir/ValueSet/list-orderfrom the FHIR Standard | |
| Composition.section:Characterisation.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:Characterisation | 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:Characterisation | 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: 7 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
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