abstractbaseDefinitioncopyrightdate- Values Differ
descriptionexperimentalfhirVersionjurisdiction
jurisdiction[0]kindnamepublisherpurposestatustitle- Values Differ
typeurlversion- Values Differ
| Left: | eCTD Substance Control of Materials Composition (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23) |
| Right: | eCTD Substance Control of Materials (http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23) |
| Error | StructureDefinition.version | Values for version differ: '2.0.0-ballot' vs '2.0.0' |
| Information | StructureDefinition.title | Values for title differ: 'eCTD Substance Control of Materials Composition' vs 'eCTD Substance Control of Materials' |
| Information | StructureDefinition.date | Values for date differ: '2024-12-12T19:00:52+00:00' vs '2025-07-08T07:43:10+00:00' |
| Name | Value | Comments | |
|---|---|---|---|
| abstract | false | ||
| baseDefinition | http://hl7.org/fhir/StructureDefinition/Composition | ||
| copyright | |||
| date | 2024-12-12T19:00:52+00:00 | 2025-07-08T07:43:10+00:00 |
|
| description | The fields needed to represent the Substance Control of Materials to be included under the eCTD 3.2.S.2.3 heading. References Sponsor Organization and Drug Substance Materials. | ||
| experimental | |||
| fhirVersion | 5.0.0 | ||
| jurisdiction | |||
| jurisdiction[0] | urn:iso:std:iso:3166#US | ||
| kind | resource | ||
| name | EctdComposition32S23 | ||
| publisher | HL7 International / Biomedical Research and Regulation | ||
| purpose | |||
| status | active | ||
| title | eCTD Substance Control of Materials Composition | eCTD Substance Control of Materials |
|
| type | Composition | ||
| url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23 | ||
| version | 2.0.0-ballot | 2.0.0 |
|
| 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 | |||||||||
| 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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||||||||
| contained | 0..* | Resource | Contained, inline Resources | 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://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use","code":"ich_3.2.s.2.3","display":"Control of Materials"}]} | Σ | 1..1 | CodeableConcept | Kind of composition (LOINC if possible) Binding: ?? (preferred): Type of a composition. Required Pattern: {"coding":[{"system":"http://terminology.hl7.org/CodeSystem/ICHContextOfUse","code":"ich_3.2.s.2.3","display":"m3.2.s.2.3 control of materials"}]} | |||||||||
| 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 | SΣ | 1..1 | LiteralReference(Drug Substance Handle) {b} | Who and/or what the composition is about | SΣ | 1..1 | LiteralReference(Drug Substance Handle) {b} | 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 | LiteralReference(Basic Organization) {b} | 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. | |||||||||
 section | SC | 1..* | BackboneElement | Composition is broken into sections | SC | 1..* | BackboneElement | Composition is broken into sections | |||||||||
 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 | 0..1 | string | Label for section (e.g. for ToC) | 0..1 | string | Label for section (e.g. for ToC) | |||||||||||
| code | 0..1 | CodeableConcept | Classification of section (recommended) Binding: ?? (example): Classification of a section of a composition/document. | 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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements | C | 0..1 | Narrative | Text summary of the section, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||||||
| orderedBy | 0..1 | CodeableConcept | Order of section entries Binding: ?? (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 | 1..* | LiteralReference(Quality Specification) {b} | A reference to data that supports this section | SC | 1..* | 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 | |||||||||||||||||