description: Amendment to a protocol. This is originally from EBM.
package_name: hl7.fhir.uv.clinical-study-protocol
derivation: constraint
name: M11_ProtocolAmendment
type: Extension
elements:
  extension:
    array: true
    min: 2
    index: 0
    slicing:
      slices:
        description:
          match: {}
          schema:
            index: 113
            extensions: {}
            elements:
              extension: {index: 114}
              url:
                pattern: {type: Uri, value: description}
                index: 115
              value:
                choices: [valueMarkdown, valueString]
                index: 117
              valueMarkdown: {type: markdown, choiceOf: value, index: 118}
              valueString: {type: string, choiceOf: value, index: 119}
        substantialImpactSafety:
          match: {}
          schema:
            mustSupport: true
            index: 82
            extensions: {}
            elements:
              extension: {index: 83}
              url:
                pattern: {type: Uri, value: substantialImpactSafety}
                index: 84
              value:
                short: Substantial impact on safety
                choices: [valueCodeableConcept]
                index: 86
              valueCodeableConcept: {type: CodeableConcept, short: Substantial impact on safety, choiceOf: value, index: 87}
        signatureUrl:
          match: {}
          schema:
            index: 50
            extensions: {}
            elements:
              extension: {index: 51}
              url:
                pattern: {type: Uri, value: signatureUrl}
                index: 52
              value:
                choices: [valueString, valueUrl]
                index: 54
              valueString: {type: string, choiceOf: value, index: 55}
              valueUrl: {type: url, choiceOf: value, index: 56}
        substantialImpactReliability:
          match: {}
          schema:
            index: 94
            extensions: {}
            elements:
              extension: {index: 95}
              url:
                pattern: {type: Uri, value: substantialImpactReliability}
                index: 96
              value:
                short: Substantial impact on reliability
                choices: [valueCodeableConcept]
                index: 98
              valueCodeableConcept: {type: CodeableConcept, short: Substantial impact on reliability, choiceOf: value, index: 99}
        approvalDate:
          match: {}
          schema:
            index: 38
            extensions: {}
            elements:
              extension: {index: 39}
              url:
                pattern: {type: Uri, value: approvalDate}
                index: 40
              value:
                choices: [valueDate]
                index: 42
              valueDate: {type: date, choiceOf: value, index: 43}
        site:
          match: {}
          schema:
            array: true
            index: 31
            extensions: {}
            elements:
              extension: {index: 32}
              url:
                pattern: {type: Uri, value: site}
                index: 33
              value:
                choices: [valueIdentifier, valueReference]
                index: 35
              valueIdentifier: {type: Identifier, choiceOf: value, index: 36}
              valueReference: {type: Reference, choiceOf: value, index: 37}
        substantialImpactSafetyComment:
          match: {}
          schema:
            mustSupport: true
            index: 88
            extensions: {}
            elements:
              extension: {index: 89}
              url:
                pattern: {type: Uri, value: substantialImpactSafetyComment}
                index: 90
              value:
                short: Comment on substantial impact on safety
                choices: [valueString]
                index: 92
              valueString: {type: string, short: Comment on substantial impact on safety, choiceOf: value, index: 93}
        signature:
          match: {}
          schema:
            index: 44
            extensions: {}
            elements:
              extension: {index: 45}
              url:
                pattern: {type: Uri, value: signature}
                index: 46
              value:
                choices: [valueSignature]
                index: 48
              valueSignature: {type: Signature, choiceOf: value, index: 49}
        scope:
          match: {}
          schema:
            mustSupport: true
            _required: true
            index: 13
            extensions: {}
            elements:
              extension: {index: 14}
              url:
                pattern: {type: Uri, value: scope}
                index: 15
              value:
                short: Global, Not Global
                choices: [valueCodeableConcept]
                index: 17
              valueCodeableConcept: {type: CodeableConcept, short: 'Global, Not Global', choiceOf: value, index: 18}
        primaryReason:
          match: {}
          schema:
            mustSupport: true
            index: 64
            extensions: {}
            elements:
              extension: {index: 65}
              url:
                pattern: {type: Uri, value: primaryReason}
                index: 66
              value:
                short: Reason for amendment, e.g. Safety
                choices: [valueCodeableConcept]
                index: 68
              valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Safety', choiceOf: value, index: 69}
        region:
          match: {}
          schema:
            array: true
            index: 25
            extensions: {}
            elements:
              extension: {index: 26}
              url:
                pattern: {type: Uri, value: region}
                index: 27
              value:
                choices: [valueCodeableConcept]
                index: 29
              valueCodeableConcept: {type: CodeableConcept, choiceOf: value, index: 30}
        summary:
          match: {}
          schema:
            mustSupport: true
            index: 76
            extensions: {}
            elements:
              extension: {index: 77}
              url:
                pattern: {type: Uri, value: summary}
                index: 78
              value:
                short: summary of changes
                choices: [valueString]
                index: 80
              valueString: {type: string, short: summary of changes, choiceOf: value, index: 81}
        substantialImpactReliabilityComment:
          match: {}
          schema:
            index: 100
            extensions: {}
            elements:
              extension: {index: 101}
              url:
                pattern: {type: Uri, value: substantialImpactReliabilityComment}
                index: 102
              value:
                short: Comment on substantial impact on reliability
                choices: [valueString]
                index: 104
              valueString: {type: string, short: Comment on substantial impact on reliability, choiceOf: value, index: 105}
        rationale:
          match: {}
          schema:
            index: 107
            extensions: {}
            elements:
              extension: {index: 108}
              url:
                pattern: {type: Uri, value: rationale}
                index: 109
              value:
                choices: [valueString]
                index: 111
              valueString: {type: string, choiceOf: value, index: 112}
        details:
          match: {}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail', index: 106}
          min: 0
        previous:
          match: {}
          schema:
            index: 7
            extensions: {}
            elements:
              extension: {index: 8}
              url:
                pattern: {type: Uri, value: previous}
                index: 9
              value:
                choices: [valueCodeableConcept]
                index: 11
              valueCodeableConcept: {type: CodeableConcept, choiceOf: value, index: 12}
        identifier:
          match: {}
          schema:
            _required: true
            index: 1
            extensions: {}
            elements:
              extension: {index: 2}
              url:
                pattern: {type: Uri, value: identifier}
                index: 3
              value:
                short: Amendment identifier
                choices: [valueIdentifier]
                index: 5
              valueIdentifier: {type: Identifier, short: Amendment identifier, choiceOf: value, index: 6}
        scopeImpact:
          match: {}
          schema: {type: Extension, mustSupport: true, url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact', index: 63}
          min: 0
          max: 3
        secondaryReason:
          match: {}
          schema:
            mustSupport: true
            array: true
            index: 70
            extensions: {}
            elements:
              extension: {index: 71}
              url:
                pattern: {type: Uri, value: secondaryReason}
                index: 72
              value:
                short: Reason for amendment, e.g. Manufacturing change
                choices: [valueCodeableConcept]
                index: 74
              valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Manufacturing change', choiceOf: value, index: 75}
        country:
          match: {}
          schema:
            array: true
            index: 19
            extensions: {}
            elements:
              extension: {index: 20}
              url:
                pattern: {type: Uri, value: country}
                index: 21
              value:
                choices: [valueCodeableConcept]
                index: 23
              valueCodeableConcept: {type: CodeableConcept, choiceOf: value, index: 24}
        signatureMethod:
          match: {}
          schema:
            index: 57
            extensions: {}
            elements:
              extension: {index: 58}
              url:
                pattern: {type: Uri, value: signatureMethod}
                index: 59
              value:
                choices: [valueString]
                index: 61
              valueString: {type: string, choiceOf: value, index: 62}
  url:
    pattern: {type: Uri, value: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment'}
    index: 120
  value:
    choices: []
    index: 122
package_version: 1.0.0-ballot2
extensions:
  description:
    url: null
    index: 113
    extensions: {}
    elements:
      extension: {index: 114}
      url:
        pattern: {type: Uri, value: description}
        index: 115
      value:
        choices: [valueMarkdown, valueString]
        index: 117
      valueMarkdown: {type: markdown, choiceOf: value, index: 118}
      valueString: {type: string, choiceOf: value, index: 119}
  substantialImpactSafety:
    url: null
    mustSupport: true
    index: 82
    extensions: {}
    elements:
      extension: {index: 83}
      url:
        pattern: {type: Uri, value: substantialImpactSafety}
        index: 84
      value:
        short: Substantial impact on safety
        choices: [valueCodeableConcept]
        index: 86
      valueCodeableConcept: {type: CodeableConcept, short: Substantial impact on safety, choiceOf: value, index: 87}
  signatureUrl:
    url: null
    index: 50
    extensions: {}
    elements:
      extension: {index: 51}
      url:
        pattern: {type: Uri, value: signatureUrl}
        index: 52
      value:
        choices: [valueString, valueUrl]
        index: 54
      valueString: {type: string, choiceOf: value, index: 55}
      valueUrl: {type: url, choiceOf: value, index: 56}
  substantialImpactReliability:
    url: null
    index: 94
    extensions: {}
    elements:
      extension: {index: 95}
      url:
        pattern: {type: Uri, value: substantialImpactReliability}
        index: 96
      value:
        short: Substantial impact on reliability
        choices: [valueCodeableConcept]
        index: 98
      valueCodeableConcept: {type: CodeableConcept, short: Substantial impact on reliability, choiceOf: value, index: 99}
  approvalDate:
    url: null
    index: 38
    extensions: {}
    elements:
      extension: {index: 39}
      url:
        pattern: {type: Uri, value: approvalDate}
        index: 40
      value:
        choices: [valueDate]
        index: 42
      valueDate: {type: date, choiceOf: value, index: 43}
  site:
    url: null
    array: true
    index: 31
    extensions: {}
    elements:
      extension: {index: 32}
      url:
        pattern: {type: Uri, value: site}
        index: 33
      value:
        choices: [valueIdentifier, valueReference]
        index: 35
      valueIdentifier: {type: Identifier, choiceOf: value, index: 36}
      valueReference: {type: Reference, choiceOf: value, index: 37}
  substantialImpactSafetyComment:
    url: null
    mustSupport: true
    index: 88
    extensions: {}
    elements:
      extension: {index: 89}
      url:
        pattern: {type: Uri, value: substantialImpactSafetyComment}
        index: 90
      value:
        short: Comment on substantial impact on safety
        choices: [valueString]
        index: 92
      valueString: {type: string, short: Comment on substantial impact on safety, choiceOf: value, index: 93}
  signature:
    url: null
    index: 44
    extensions: {}
    elements:
      extension: {index: 45}
      url:
        pattern: {type: Uri, value: signature}
        index: 46
      value:
        choices: [valueSignature]
        index: 48
      valueSignature: {type: Signature, choiceOf: value, index: 49}
  scope:
    url: null
    mustSupport: true
    _required: true
    index: 13
    extensions: {}
    elements:
      extension: {index: 14}
      url:
        pattern: {type: Uri, value: scope}
        index: 15
      value:
        short: Global, Not Global
        choices: [valueCodeableConcept]
        index: 17
      valueCodeableConcept: {type: CodeableConcept, short: 'Global, Not Global', choiceOf: value, index: 18}
  primaryReason:
    url: null
    mustSupport: true
    index: 64
    extensions: {}
    elements:
      extension: {index: 65}
      url:
        pattern: {type: Uri, value: primaryReason}
        index: 66
      value:
        short: Reason for amendment, e.g. Safety
        choices: [valueCodeableConcept]
        index: 68
      valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Safety', choiceOf: value, index: 69}
  region:
    url: null
    array: true
    index: 25
    extensions: {}
    elements:
      extension: {index: 26}
      url:
        pattern: {type: Uri, value: region}
        index: 27
      value:
        choices: [valueCodeableConcept]
        index: 29
      valueCodeableConcept: {type: CodeableConcept, choiceOf: value, index: 30}
  summary:
    url: null
    mustSupport: true
    index: 76
    extensions: {}
    elements:
      extension: {index: 77}
      url:
        pattern: {type: Uri, value: summary}
        index: 78
      value:
        short: summary of changes
        choices: [valueString]
        index: 80
      valueString: {type: string, short: summary of changes, choiceOf: value, index: 81}
  substantialImpactReliabilityComment:
    url: null
    index: 100
    extensions: {}
    elements:
      extension: {index: 101}
      url:
        pattern: {type: Uri, value: substantialImpactReliabilityComment}
        index: 102
      value:
        short: Comment on substantial impact on reliability
        choices: [valueString]
        index: 104
      valueString: {type: string, short: Comment on substantial impact on reliability, choiceOf: value, index: 105}
  rationale:
    url: null
    index: 107
    extensions: {}
    elements:
      extension: {index: 108}
      url:
        pattern: {type: Uri, value: rationale}
        index: 109
      value:
        choices: [valueString]
        index: 111
      valueString: {type: string, choiceOf: value, index: 112}
  details: {url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail', min: 0, type: Extension, mustSupport: true, index: 106}
  previous:
    url: null
    index: 7
    extensions: {}
    elements:
      extension: {index: 8}
      url:
        pattern: {type: Uri, value: previous}
        index: 9
      value:
        choices: [valueCodeableConcept]
        index: 11
      valueCodeableConcept: {type: CodeableConcept, choiceOf: value, index: 12}
  identifier:
    url: null
    _required: true
    index: 1
    extensions: {}
    elements:
      extension: {index: 2}
      url:
        pattern: {type: Uri, value: identifier}
        index: 3
      value:
        short: Amendment identifier
        choices: [valueIdentifier]
        index: 5
      valueIdentifier: {type: Identifier, short: Amendment identifier, choiceOf: value, index: 6}
  scopeImpact: {url: 'http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact', min: 0, max: 3, type: Extension, mustSupport: true, index: 63}
  secondaryReason:
    url: null
    mustSupport: true
    array: true
    index: 70
    extensions: {}
    elements:
      extension: {index: 71}
      url:
        pattern: {type: Uri, value: secondaryReason}
        index: 72
      value:
        short: Reason for amendment, e.g. Manufacturing change
        choices: [valueCodeableConcept]
        index: 74
      valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Manufacturing change', choiceOf: value, index: 75}
  country:
    url: null
    array: true
    index: 19
    extensions: {}
    elements:
      extension: {index: 20}
      url:
        pattern: {type: Uri, value: country}
        index: 21
      value:
        choices: [valueCodeableConcept]
        index: 23
      valueCodeableConcept: {type: CodeableConcept, choiceOf: value, index: 24}
  signatureMethod:
    url: null
    index: 57
    extensions: {}
    elements:
      extension: {index: 58}
      url:
        pattern: {type: Uri, value: signatureMethod}
        index: 59
      value:
        choices: [valueString]
        index: 61
      valueString: {type: string, choiceOf: value, index: 62}
class: extension
kind: complex-type
url: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
base: http://hl7.org/fhir/StructureDefinition/Extension
version: 1.0.0-ballot2