## Profile Comparison between http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23 vs http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23

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)

### Messages

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 '2025-07-03T13:07:08+00:00'

### Metadata

Name | Value | Comments
--- | --- | ---
abstract | false |
baseDefinition | http://hl7.org/fhir/StructureDefinition/Composition |
copyright |  |
date | 2024-12-12T19:00:52+00:00 | 2025-07-03T13:07:08+00:00 | Values Differ
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 | Values Differ
type | Composition |
url | http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s23 |
version | 2.0.0-ballot | 2.0.0 | Values Differ

### Structure

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
Additional Bindings | Purpose
?? | Starter
|  | 0..1 | code | Language of the resource content Binding: ?? (required): IETF language tag for a human language
Additional Bindings | Purpose
?? | Starter
text |  | 0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements |  | 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 | S Σ | 0..1 | Identifier | Version-independent identifier for the Composition | S Σ | 0..1 | Identifier | Version-independent identifier for the Composition |
version | Σ | 0..1 | string | An explicitly assigned identifer of a variation of the content in the Composition | 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 | S Σ | 1..1 | LiteralReference(Drug Substance Handle) {b} | Who and/or what the composition is about | S Σ | 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 | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition | S Σ | 1..1 | LiteralReference(Basic Organization) {b} | Who and/or what authored the composition |
name | Σ | 0..1 | string | Name for this Composition (computer friendly) | Σ | 0..1 | string | Name for this Composition (computer friendly) |
title | S Σ | 1..1 | string | Human Readable name/title | S Σ | 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 | S C | 1..* | BackboneElement | Composition is broken into sections | S C | 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 | S C | 1..* | LiteralReference(Quality Specification) {b} | A reference to data that supports this section | S C | 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