description: Alternate structure present in the drug substance
package_name: hl7.fhir.us.pq-cmc-fda
derivation: constraint
name: PolymorphicForm
type: SubstanceDefinition
elements:
  meta:
    elements:
      profile: {mustSupport: true, index: 0}
    required: [profile]
  identifier: {short: optional user designated identifier, mustSupport: true, index: 1}
  structure:
    mustSupport: true
    index: 2
    elements:
      molecularFormula: {short: Molecular Formula, mustSupport: true, index: 3}
      technique:
        short: Substance Characterization Technique
        mustSupport: true
        index: 4
        elements:
          text: {mustSupport: true, index: 5}
        required: [text]
      representation:
        mustSupport: true
        index: 6
        elements:
          representation: {short: Structural Representation, mustSupport: true, index: 7}
          format:
            short: Structural Representation Type
            mustSupport: true
            index: 8
            elements:
              coding:
                binding: {strength: required, valueSet: 'http://hl7.org/fhir/us/pq-cmc-fda/ValueSet/pqcmc-chemical-structure-datafile-type-terminology'}
                index: 9
          document:
            type: Reference
            mustSupport: true
            refers: ['http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-document-reference']
            index: 10
    required: [representation]
  code:
    mustSupport: true
    index: 11
    elements:
      code:
        elements:
          coding:
            short: UNII
            index: 12
            elements:
              system:
                pattern: {type: Uri, value: 'http://fdasis.nlm.nih.gov'}
                index: 13
  name:
    short: Substance Name
    constraint:
      cmc-name-preferred: {human: 'Name.preferred: at most one = true', source: 'http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form', severity: error, expression: select(preferred = true).count() < 2}
    mustSupport: true
    index: 14
    elements:
      preferred: {short: True when the name type is Substance Name, mustSupport: true, index: 15}
    slicing:
      rules: closed
      description: Slice based on value pattern
      discriminator:
      - {path: type.coding, type: value}
      min: 1
      slices:
        sub:
          match:
            type:
              coding: {code: C97054, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Generic Name}
          schema:
            mustSupport: true
            index: 16
            elements:
              name: {short: Generic Name, mustSupport: true, index: 17}
              type:
                mustSupport: true
                index: 18
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C97054, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: Generic Name}
                    index: 19
                required: [coding]
              preferred: {mustSupport: true, index: 20}
            required: [type]
        gsrs:
          match:
            type:
              coding: {code: C203355, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: GSRS Preferred Term}
          schema:
            mustSupport: true
            index: 21
            elements:
              name: {short: GSRS Preferred Term, mustSupport: true, index: 22}
              type:
                mustSupport: true
                index: 23
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C203355, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: GSRS Preferred Term}
                    index: 24
                required: [coding]
              preferred: {mustSupport: true, index: 25}
            required: [type]
        isbt:
          match:
            type:
              coding: {code: C95517, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: ISBT-128 DIN}
          schema:
            mustSupport: true
            index: 26
            elements:
              name: {short: ISBT-128 DIN, mustSupport: true, index: 27}
              type:
                mustSupport: true
                index: 28
                elements:
                  coding:
                    mustSupport: true
                    pattern:
                      type: Coding
                      value: {code: C95517, system: 'http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy', display: ISBT-128 DIN}
                    index: 29
                required: [coding]
              preferred: {mustSupport: true, index: 30}
            required: [type]
package_version: 1.0.0-ballot
class: profile
kind: resource
url: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-polymorphic-form
base: http://hl7.org/fhir/StructureDefinition/SubstanceDefinition
version: 1.0.0-ballot
required: [name]