abstractbaseDefinitioncopyrightdate- Values Differ
description- Values Differ
experimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitletypeurlversion- Values Differ
| Left: | eCTD Specification Composition (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151) |
| Right: | eCTD Specification Composition (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151) |
| Error | StructureDefinition.version | Values for version differ: '1.0.0-ballot' vs '1.0.0' |
| Information | StructureDefinition.date | Values for date differ: '2024-04-08T17:51:06+00:00' vs '2024-12-11T13:47:08+00:00' |
| Warning | Composition.type | Elements differ in definition for mustSupport: 'false' vs 'true' |
| Information | StructureDefinition.requirements | Values for requirements differ: 'dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring this version of the Composition. When packaged in a document, [Bundle.timestamp](bundle-definitions.html#Bundle.timestamp) is the date of packaging.' vs 'dateTime is used for tracking, organizing versions and searching. Note that this is the time of authoring this version of the Composition. When packaged in a document, [Bundle.timestamp](http://hl7.org/fhir/R5/bundle-definitions.html#Bundle.timestamp) is the date of packaging.' |
| Warning | Composition.section.code | Elements differ in definition for mustSupport: 'true' vs 'false' |
| Information | Composition.section.code | Element minimum cardinalities differ: '1' vs '0' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/Composition | ||
| copyright | |||
| date | 2024-04-08T17:51:06+00:00 | 2024-12-11T13:47:08+00:00 |
|
| description | The fields needed to Quality Specifications for APIs, Drug Substances, Excipients and Raw Materials. | The fields needed to represent Quality Specifications for APIs, Drug Substances, Excipients and Raw Materials. |
|
| experimental | |||
| fhirVersion | 5.0.0 | ||
| jurisdiction | |||
| jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | EctdCompositionSP4151 | ||
| publisher | HL7 International / Biomedical Research and Regulation | ||
| purpose | |||
| status | active | ||
| title | eCTD Specification Composition | ||
| type | Composition | ||
| url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151 | ||
| version | 1.0.0-ballot | 1.0.0 |
|
| Name | L Flags | L Card. | L Type | L Description & Constraints | R Flags | R Card. | R Type | R Description & Constraints | Comments | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 Composition | 0..* | Composition | A set of resources composed into a single coherent clinical statement with clinical attestation | 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 | Σ | 0..1 | id | Logical id of this artifact | |||||||||
 meta | Σ | 0..1 | Meta | Metadata about the resource | Σ | 0..1 | Meta | Metadata about the resource | |||||||||
 id | 0..1 | id | Unique id for inter-element referencing |
| |||||||||||||
 Slices for extension | 0..* | Extension | Additional content defined by implementations Slice: Unordered, Open by value:url |
| |||||||||||||
| versionId | Σ | 0..1 | id | Version specific identifier |
| ||||||||||||
| lastUpdated | Σ | 0..1 | instant | When the resource version last changed |
| ||||||||||||
| source | Σ | 0..1 | uri | Identifies where the resource comes from |
| ||||||||||||
| profile | SΣ | 1..1 | canonical(StructureDefinition) | Profiles this resource claims to conform to |
| ||||||||||||
| security | Σ | 0..* | Coding | Security Labels applied to this resource Binding: ?? (extensible): Security Labels from the Healthcare Privacy and Security Classification System. |
| ||||||||||||
| tag | Σ | 0..* | Coding | Tags applied to this resource Binding: ?? (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones". |
| ||||||||||||
| implicitRules | ?!Σ | 0..1 | uri | A set of rules under which this content was created | ?!Σ | 0..1 | uri | A set of rules under which this content was created | |||||||||
| language | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
| |||||||||||
| text | 0..1 | Narrative | Text summary of the resource, for human interpretation | 0..1 | Narrative | Text summary of the resource, for human interpretation | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 0..* | Resource | Contained, inline Resources | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
 modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | ?!Σ | 0..* | Extension | Extensions that cannot be ignored | |||||||||
| url | Σ | 0..1 | uri | Canonical identifier for this Composition, represented as a URI (globally unique) | 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 | 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 | 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: ?? (required): The workflow/clinical status of the composition. Required Pattern: final | ?!Σ | 1..1 | code | registered | partial | preliminary | final | amended | corrected | appended | cancelled | entered-in-error | deprecated | unknown Binding: ?? (required): The workflow/clinical status of the composition. Required Pattern: final | |||||||||
| type | Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: ?? (preferred): Type of a composition. Required Pattern: {"coding":[{"system":"http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/pqcmc-comp-section-types","code":"SP4151","display":"Quality Specification"}]} | SΣ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: ?? (preferred): Type of a composition. |
| ||||||||
| category | Σ | 0..* | CodeableConcept | Categorization of Composition Binding: ?? (example): High-level kind of a clinical document at a macro level. | Σ | 0..* | CodeableConcept | Categorization of Composition Binding: ?? (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 | Σ | 0..* | Reference(Resource) | Who and/or what the composition is about | |||||||||
| encounter | Σ | 0..1 | Reference(Encounter) | Context of the Composition | Σ | 0..1 | Reference(Encounter) | Context of the Composition | |||||||||
| date | Σ | 1..1 | dateTime | Composition editing time | Σ | 1..1 | dateTime | Composition editing time | |||||||||
| useContext | Σ | 0..* | UsageContext | The context that the content is intended to support | Σ | 0..* | UsageContext | The context that the content is intended to support | |||||||||
| author | SΣ | 1..1 | Reference(Sponsor Organization) | Who and/or what authored the composition | 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) | Σ | 0..1 | string | Name for this Composition (computer friendly) | |||||||||
| title | SΣ | 1..1 | string | Human Readable name/title | SΣ | 1..1 | string | Human Readable name/title | |||||||||
| note | 0..* | Annotation | For any additional notes | 0..* | Annotation | For any additional notes | |||||||||||
| attester | 0..* | BackboneElement | Attests to accuracy of composition | 0..* | BackboneElement | Attests to accuracy of composition | |||||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| mode | 1..1 | CodeableConcept | personal | professional | legal | official Binding: ?? (preferred): The way in which a person authenticated a composition. | 1..1 | CodeableConcept | personal | professional | legal | official Binding: ?? (preferred): The way in which a person authenticated a composition. | |||||||||||
| time | 0..1 | dateTime | When the composition was attested | 0..1 | dateTime | When the composition was attested | |||||||||||
| party | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) | Who attested the composition | 0..1 | Reference(Patient | RelatedPerson | Practitioner | PractitionerRole | Organization) | Who attested the composition | |||||||||||
| custodian | Σ | 0..1 | Reference(Organization) | Organization which maintains the composition | Σ | 0..1 | Reference(Organization) | Organization which maintains the composition | |||||||||
| relatesTo | 0..* | RelatedArtifact | Relationships to other compositions/documents | 0..* | RelatedArtifact | Relationships to other compositions/documents | |||||||||||
| event | Σ | 0..* | BackboneElement | The clinical service(s) being documented | Σ | 0..* | BackboneElement | The clinical service(s) being documented | |||||||||
| id | 0..1 | string | Unique id for inter-element referencing | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| period | Σ | 0..1 | Period | The period covered by the documentation | 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: ?? (example): This list of codes represents the main clinical acts being documented. | Σ | 0..* | CodeableReference(Resource) | The event(s) being documented, as code(s), reference(s), or both Binding: ?? (example): This list of codes represents the main clinical acts being documented. | |||||||||
 Slices for section | SC | 1..1 | BackboneElement | Composition is broken into sections Slice: Unordered, Closed 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 | 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 | 0..1 | string | Unique id for inter-element referencing | |||||||||||
| extension | 0..* | Extension | Additional content defined by implementations | 0..* | Extension | Additional content defined by implementations | |||||||||||
| modifierExtension | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | |||||||||
| title | S | 1..1 | string | Label for section (e.g. for ToC) | S | 1..1 | string | Label for section (e.g. for ToC) | |||||||||
| code | S | 1..1 | CodeableConcept | Classification of section (recommended) Binding: ?? (required) | 0..1 | CodeableConcept | Classification of section (recommended) Binding: ?? (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 | 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 | 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 | C | 0..1 | Narrative | Text summary of the section, for human interpretation | |||||||||
| orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ?? (preferred): What order applies to the items in the entry. | 0..1 | CodeableConcept | Order of section entries Binding: ?? (preferred): What order applies to the items in the entry. | |||||||||||
| entry | SC | 0..* | Reference(Resource) | A reference to data that supports this section | SC | 0..* | LiteralReference(Quality Specification) {b} | A reference to data that supports this section | |||||||||
| emptyReason | C | 0..1 | CodeableConcept | Why the section is empty Binding: ?? (preferred): If a section is empty, why it is empty. | C | 0..1 | CodeableConcept | Why the section is empty Binding: ?? (preferred): If a section is empty, why it is empty. | |||||||||
 section | 0..* | See section (Composition) | Nested Section | 0..* | See section (Composition) | Nested Section | |||||||||||
| Documentation for this format | |||||||||||||||||