description: Amendment to a protocol. This is originally from EBM.
package_name: hl7.fhir.uv.pharmaceutical-research-protocol
derivation: constraint
name: M11_ProtocolAmendment
type: Extension
elements:
  extension:
    index: 0
    slicing:
      slices:
        description:
          match: {}
          schema:
            index: 99
            extensions: {}
            elements:
              extension: {index: 100}
              url:
                pattern: {type: Uri, value: description}
                index: 101
              value:
                choices: [valueString]
                index: 103
              valueString: {type: string, choiceOf: value, index: 104}
        substantialImpactSafety:
          match: {}
          schema:
            index: 68
            extensions: {}
            elements:
              extension: {index: 69}
              url:
                pattern: {type: Uri, value: substantialImpactSafety}
                index: 70
              value:
                short: Substantial impact on safety
                choices: [valueCode]
                index: 72
              valueCode: {type: code, short: Substantial impact on safety, choiceOf: value, index: 73}
        substantialImpactReliability:
          match: {}
          schema:
            index: 80
            extensions: {}
            elements:
              extension: {index: 81}
              url:
                pattern: {type: Uri, value: substantialImpactReliability}
                index: 82
              value:
                short: Substantial impact on reliability
                choices: [valueCode]
                index: 84
              valueCode: {type: code, short: Substantial impact on reliability, choiceOf: value, index: 85}
        approvalDate:
          match: {}
          schema:
            index: 25
            extensions: {}
            elements:
              extension: {index: 26}
              url:
                pattern: {type: Uri, value: approvalDate}
                index: 27
              value:
                choices: [valueDate]
                index: 29
              valueDate: {type: date, choiceOf: value, index: 30}
        site:
          match: {}
          schema:
            array: true
            index: 19
            extensions: {}
            elements:
              extension: {index: 20}
              url:
                pattern: {type: Uri, value: site}
                index: 21
              value:
                choices: [valueIdentifier]
                index: 23
              valueIdentifier: {type: Identifier, choiceOf: value, index: 24}
        substantialImpactSafetyComment:
          match: {}
          schema:
            index: 74
            extensions: {}
            elements:
              extension: {index: 75}
              url:
                pattern: {type: Uri, value: substantialImpactSafetyComment}
                index: 76
              value:
                short: Comment on substantial impact on safety
                choices: [valueString]
                index: 78
              valueString: {type: string, short: Comment on substantial impact on safety, choiceOf: value, index: 79}
        signature:
          match: {}
          schema:
            index: 31
            extensions: {}
            elements:
              extension: {index: 32}
              url:
                pattern: {type: Uri, value: signature}
                index: 33
              value:
                choices: [valueSignature]
                index: 35
              valueSignature: {type: Signature, choiceOf: value, index: 36}
        scope:
          match: {}
          schema:
            _required: true
            index: 1
            extensions: {}
            elements:
              extension: {index: 2}
              url:
                pattern: {type: Uri, value: scope}
                index: 3
              value:
                short: Global, Not Global
                choices: [valueCode]
                index: 5
              valueCode: {type: code, short: 'Global, Not Global', choiceOf: value, index: 6}
        primaryReason:
          match: {}
          schema:
            index: 50
            extensions: {}
            elements:
              extension: {index: 51}
              url:
                pattern: {type: Uri, value: primaryReason}
                index: 52
              value:
                short: Reason for amendment, e.g. Safety
                choices: [valueCodeableConcept]
                index: 54
              valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Safety', choiceOf: value, index: 55}
        region:
          match: {}
          schema:
            array: true
            index: 13
            extensions: {}
            elements:
              extension: {index: 14}
              url:
                pattern: {type: Uri, value: region}
                index: 15
              value:
                choices: [valueCode]
                index: 17
              valueCode: {type: code, choiceOf: value, index: 18}
        summary:
          match: {}
          schema:
            index: 62
            extensions: {}
            elements:
              extension: {index: 63}
              url:
                pattern: {type: Uri, value: summary}
                index: 64
              value:
                short: summary of changes
                choices: [valueString]
                index: 66
              valueString: {type: string, short: summary of changes, choiceOf: value, index: 67}
        substantialImpactReliabilityComment:
          match: {}
          schema:
            index: 86
            extensions: {}
            elements:
              extension: {index: 87}
              url:
                pattern: {type: Uri, value: substantialImpactReliabilityComment}
                index: 88
              value:
                short: Comment on substantial impact on reliability
                choices: [valueString]
                index: 90
              valueString: {type: string, short: Comment on substantial impact on reliability, choiceOf: value, index: 91}
        signatureURL:
          match: {}
          schema:
            index: 37
            extensions: {}
            elements:
              extension: {index: 38}
              url:
                pattern: {type: Uri, value: signatureURL}
                index: 39
              value:
                choices: [valueString]
                index: 41
              valueString: {type: string, choiceOf: value, index: 42}
        rationale:
          match: {}
          schema:
            index: 93
            extensions: {}
            elements:
              extension: {index: 94}
              url:
                pattern: {type: Uri, value: rationale}
                index: 95
              value:
                choices: [valueString]
                index: 97
              valueString: {type: string, choiceOf: value, index: 98}
        details:
          match: {}
          schema: {type: Extension, url: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail', index: 92}
          min: 0
        scopeImpact:
          match: {}
          schema: {type: Extension, url: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact', index: 49}
          min: 0
          max: 3
        secondaryReason:
          match: {}
          schema:
            index: 56
            extensions: {}
            elements:
              extension: {index: 57}
              url:
                pattern: {type: Uri, value: secondaryReason}
                index: 58
              value:
                short: Reason for amendment, e.g. Manufacturing change
                choices: [valueCodeableConcept]
                index: 60
              valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Manufacturing change', choiceOf: value, index: 61}
        country:
          match: {}
          schema:
            array: true
            index: 7
            extensions: {}
            elements:
              extension: {index: 8}
              url:
                pattern: {type: Uri, value: country}
                index: 9
              value:
                choices: [valueCode]
                index: 11
              valueCode: {type: code, choiceOf: value, index: 12}
        signatureMethod:
          match: {}
          schema:
            index: 43
            extensions: {}
            elements:
              extension: {index: 44}
              url:
                pattern: {type: Uri, value: signatureMethod}
                index: 45
              value:
                choices: [valueString]
                index: 47
              valueString: {type: string, choiceOf: value, index: 48}
  url:
    pattern: {type: Uri, value: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment'}
    index: 105
  value:
    choices: []
    index: 107
package_version: 1.0.0-ballot
extensions:
  description:
    url: null
    index: 99
    extensions: {}
    elements:
      extension: {index: 100}
      url:
        pattern: {type: Uri, value: description}
        index: 101
      value:
        choices: [valueString]
        index: 103
      valueString: {type: string, choiceOf: value, index: 104}
  substantialImpactSafety:
    url: null
    index: 68
    extensions: {}
    elements:
      extension: {index: 69}
      url:
        pattern: {type: Uri, value: substantialImpactSafety}
        index: 70
      value:
        short: Substantial impact on safety
        choices: [valueCode]
        index: 72
      valueCode: {type: code, short: Substantial impact on safety, choiceOf: value, index: 73}
  substantialImpactReliability:
    url: null
    index: 80
    extensions: {}
    elements:
      extension: {index: 81}
      url:
        pattern: {type: Uri, value: substantialImpactReliability}
        index: 82
      value:
        short: Substantial impact on reliability
        choices: [valueCode]
        index: 84
      valueCode: {type: code, short: Substantial impact on reliability, choiceOf: value, index: 85}
  approvalDate:
    url: null
    index: 25
    extensions: {}
    elements:
      extension: {index: 26}
      url:
        pattern: {type: Uri, value: approvalDate}
        index: 27
      value:
        choices: [valueDate]
        index: 29
      valueDate: {type: date, choiceOf: value, index: 30}
  site:
    url: null
    array: true
    index: 19
    extensions: {}
    elements:
      extension: {index: 20}
      url:
        pattern: {type: Uri, value: site}
        index: 21
      value:
        choices: [valueIdentifier]
        index: 23
      valueIdentifier: {type: Identifier, choiceOf: value, index: 24}
  substantialImpactSafetyComment:
    url: null
    index: 74
    extensions: {}
    elements:
      extension: {index: 75}
      url:
        pattern: {type: Uri, value: substantialImpactSafetyComment}
        index: 76
      value:
        short: Comment on substantial impact on safety
        choices: [valueString]
        index: 78
      valueString: {type: string, short: Comment on substantial impact on safety, choiceOf: value, index: 79}
  signature:
    url: null
    index: 31
    extensions: {}
    elements:
      extension: {index: 32}
      url:
        pattern: {type: Uri, value: signature}
        index: 33
      value:
        choices: [valueSignature]
        index: 35
      valueSignature: {type: Signature, choiceOf: value, index: 36}
  scope:
    url: null
    _required: true
    index: 1
    extensions: {}
    elements:
      extension: {index: 2}
      url:
        pattern: {type: Uri, value: scope}
        index: 3
      value:
        short: Global, Not Global
        choices: [valueCode]
        index: 5
      valueCode: {type: code, short: 'Global, Not Global', choiceOf: value, index: 6}
  primaryReason:
    url: null
    index: 50
    extensions: {}
    elements:
      extension: {index: 51}
      url:
        pattern: {type: Uri, value: primaryReason}
        index: 52
      value:
        short: Reason for amendment, e.g. Safety
        choices: [valueCodeableConcept]
        index: 54
      valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Safety', choiceOf: value, index: 55}
  region:
    url: null
    array: true
    index: 13
    extensions: {}
    elements:
      extension: {index: 14}
      url:
        pattern: {type: Uri, value: region}
        index: 15
      value:
        choices: [valueCode]
        index: 17
      valueCode: {type: code, choiceOf: value, index: 18}
  summary:
    url: null
    index: 62
    extensions: {}
    elements:
      extension: {index: 63}
      url:
        pattern: {type: Uri, value: summary}
        index: 64
      value:
        short: summary of changes
        choices: [valueString]
        index: 66
      valueString: {type: string, short: summary of changes, choiceOf: value, index: 67}
  substantialImpactReliabilityComment:
    url: null
    index: 86
    extensions: {}
    elements:
      extension: {index: 87}
      url:
        pattern: {type: Uri, value: substantialImpactReliabilityComment}
        index: 88
      value:
        short: Comment on substantial impact on reliability
        choices: [valueString]
        index: 90
      valueString: {type: string, short: Comment on substantial impact on reliability, choiceOf: value, index: 91}
  signatureURL:
    url: null
    index: 37
    extensions: {}
    elements:
      extension: {index: 38}
      url:
        pattern: {type: Uri, value: signatureURL}
        index: 39
      value:
        choices: [valueString]
        index: 41
      valueString: {type: string, choiceOf: value, index: 42}
  rationale:
    url: null
    index: 93
    extensions: {}
    elements:
      extension: {index: 94}
      url:
        pattern: {type: Uri, value: rationale}
        index: 95
      value:
        choices: [valueString]
        index: 97
      valueString: {type: string, choiceOf: value, index: 98}
  details: {url: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail', min: 0, type: Extension, index: 92}
  scopeImpact: {url: 'http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact', min: 0, max: 3, type: Extension, index: 49}
  secondaryReason:
    url: null
    index: 56
    extensions: {}
    elements:
      extension: {index: 57}
      url:
        pattern: {type: Uri, value: secondaryReason}
        index: 58
      value:
        short: Reason for amendment, e.g. Manufacturing change
        choices: [valueCodeableConcept]
        index: 60
      valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Manufacturing change', choiceOf: value, index: 61}
  country:
    url: null
    array: true
    index: 7
    extensions: {}
    elements:
      extension: {index: 8}
      url:
        pattern: {type: Uri, value: country}
        index: 9
      value:
        choices: [valueCode]
        index: 11
      valueCode: {type: code, choiceOf: value, index: 12}
  signatureMethod:
    url: null
    index: 43
    extensions: {}
    elements:
      extension: {index: 44}
      url:
        pattern: {type: Uri, value: signatureMethod}
        index: 45
      value:
        choices: [valueString]
        index: 47
      valueString: {type: string, choiceOf: value, index: 48}
class: extension
kind: complex-type
url: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment
base: http://hl7.org/fhir/StructureDefinition/Extension
version: 1.0.0-ballot
required: [extension]