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 relatesTo attribute. '
package_name: hl7.fhir.uv.clinical-study-protocol
derivation: constraint
name: M11_ResearchStudyProfile
type: ResearchStudy
elements:
  extension:
    index: 0
    slicing:
      rules: open
      ordered: false
      discriminator:
      - {path: url, type: value}
      min: 1
      slices:
        narrative:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements', index: 1}
          min: 0
        amendment:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment', index: 2}
          min: 0
          max: 1
        confidentialityStatement:
          match: {url: null}
          schema: {type: Extension, url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement', index: 3}
          min: 0
          max: 1
        approval:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval', index: 4}
          min: 0
          max: 1
        m11-research-study:
          match: {url: null}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study', index: 5}
          min: 1
          max: 1
  identifier:
    mustSupport: true
    index: 6
    elements:
      type:
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-identifier-type-vs'}
        isModifier: true
        mustSupport: true
        isModifierReason: Protocols may have multiple business identifers from a given system - only with a type can they be distinguished.
        index: 7
        elements:
          coding:
            elements:
              code: {index: 8}
            required: [code]
    required: [type]
  title: {mustSupport: true, index: 9}
  label:
    elements:
      type:
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-study-title-type-vs'}
        index: 10
  relatesTo:
    elements:
      type: {index: 11}
  phase:
    binding: {strength: required, valueSet: 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-phase-vs'}
    mustSupport: true
    index: 12
  focus: {index: 13}
  associatedParty:
    elements:
      role:
        binding: {strength: extensible, valueSet: 'http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-party-role-type-vs'}
        index: 14
      party:
        elements:
          reference: {mustSupport: true, index: 15}
package_version: 1.0.0-ballot2
extensions:
  narrative: {url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/narrative-elements', min: 0, type: Extension, mustSupport: true, index: 1}
  amendment: {url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment', min: 0, max: 1, type: Extension, mustSupport: true, index: 2}
  confidentialityStatement: {url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-confidentiality-statement', min: 0, max: 1, type: Extension, index: 3}
  approval: {url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval', min: 0, max: 1, type: Extension, mustSupport: true, index: 4}
  m11-research-study: {url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study', min: 1, max: 1, type: Extension, mustSupport: true, index: 5}
class: profile
kind: resource
url: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile
base: http://hl7.org/fhir/StructureDefinition/ResearchStudy
version: 1.0.0-ballot2
required: [extension, identifier]