description: 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
package_name: hl7.fhir.us.pq
derivation: constraint
name: EctdComposition32S3
type: Composition
elements:
  identifier: {mustSupport: true, index: 0}
  status:
    pattern: {type: Code, value: final}
    index: 1
  type:
    pattern:
      type: CodeableConcept
      value:
        coding:
        - {code: ich_3.2.s.3, system: 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use', display: Characterisation}
    index: 2
  author:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization']
    index: 3
  title: {mustSupport: true, index: 4}
  section:
    mustSupport: true
    index: 5
    slicing:
      rules: open
      description: Slice based on the different sections that are needed in an ectd document.
      discriminator:
      - {path: code, type: value}
      min: 1
      slices:
        Structure:
          match:
            code:
              coding:
              - {code: ich_3.2.s.3.1, system: 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use', display: Elucidation of Structure and other Characteristics}
          schema:
            mustSupport: true
            _required: true
            index: 6
            elements:
              title: {mustSupport: true, index: 7}
              code:
                mustSupport: true
                pattern:
                  type: CodeableConcept
                  value:
                    coding:
                    - {code: ich_3.2.s.3.1, system: 'http://terminology.hl7.org/temporary-uri/codeSystem/ICH-context-of-use', display: Elucidation of Structure and other Characteristics}
                index: 8
              entry:
                type: Reference
                mustSupport: true
                refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-substance-characterisation']
                index: 9
            required: [entry, title, code]
package_version: cmc-fda-2.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32s3
base: http://hl7.org/fhir/StructureDefinition/Composition
version: 2.0.0-ballot
required: [section]