description: 'Constraint of ResearchStudy to M11 Guidance\nAn instance of this profile represents a single version of the protocol definition. Previous amendments are represented\nby further instances of ResearchStudy linked through the relatedArtifact attribute. '
package_name: hl7.fhir.uv.pharmaceutical
derivation: constraint
name: M11_ResearchStudyProfile
type: ResearchStudy
elements:
  extension:
    type: Extension
    url: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements
    index: 0
    slicing:
      slices:
        narrative:
          match: {}
          schema: {type: Extension, url: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements', index: 0}
          min: 0
        amendment:
          match: {}
          schema: {type: Extension, url: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment', index: 1}
          min: 0
          max: 1
  identifier:
    elements:
      type:
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-identifier-type-vs'}
        isModifier: true
        isModifierReason: Protocols may have multiple business identifers from a given system - only with a type can they be distinguished.
        index: 2
        elements:
          coding:
            elements:
              code: {index: 3}
            required: [code]
    required: [type]
  label:
    elements:
      type:
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/ddf-study-title-type-vs'}
        index: 4
  relatesTo:
    elements:
      type: {index: 5}
  phase:
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-phase-vs'}
    index: 6
  focus: {index: 7}
  associatedParty:
    elements:
      role:
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/nci-study-role-vs'}
        index: 8
package_version: research-protocol-1.0.0-ballot
extensions:
  narrative: {url: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements', min: 0, type: Extension, index: 0}
  amendment: {url: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment', min: 0, max: 1, type: Extension, index: 1}
class: profile
kind: resource
url: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-profile
base: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/study-design
version: 1.0.0-ballot