description: An amendment to a study protocol.
package_name: hl7.fhir.uv.ebm
derivation: constraint
name: ResearchStudyStudyAmendment
type: Extension
elements:
  extension:
    index: 0
    slicing:
      slices:
        description:
          match: {}
          schema:
            index: 12
            extensions: {}
            elements:
              extension: {index: 13}
              url:
                pattern: {type: Uri, value: description}
                index: 14
              value:
                short: Description
                choices: [valueString]
                index: 16
              valueString: {type: string, short: Description, choiceOf: value, index: 17}
        substantialImpactSafety:
          match: {}
          schema:
            index: 24
            extensions: {}
            elements:
              extension: {index: 25}
              url:
                pattern: {type: Uri, value: substantialImpactSafety}
                index: 26
              value:
                short: Substantial impact on safety
                choices: [valueBoolean]
                index: 28
              valueBoolean: {type: boolean, short: Substantial impact on safety, choiceOf: value, index: 29}
        substantialImpactReliability:
          match: {}
          schema:
            index: 36
            extensions: {}
            elements:
              extension: {index: 37}
              url:
                pattern: {type: Uri, value: substantialImpactReliability}
                index: 38
              value:
                short: Substantial impact on reliability
                choices: [valueBoolean]
                index: 40
              valueBoolean: {type: boolean, short: Substantial impact on reliability, choiceOf: value, index: 41}
        substantialImpactSafetyComment:
          match: {}
          schema:
            index: 30
            extensions: {}
            elements:
              extension: {index: 31}
              url:
                pattern: {type: Uri, value: substantialImpactSafetyComment}
                index: 32
              value:
                short: Comment on substantial impact on safety
                choices: [valueString]
                index: 34
              valueString: {type: string, short: Comment on substantial impact on safety, choiceOf: value, index: 35}
        scope:
          match: {}
          schema:
            index: 6
            extensions: {}
            elements:
              extension: {index: 7}
              url:
                pattern: {type: Uri, value: scope}
                index: 8
              value:
                short: Global, Coutnry, Region, or Site
                choices: [valueString]
                index: 10
              valueString: {type: string, short: 'Global, Coutnry, Region, or Site', choiceOf: value, index: 11}
        primaryReason:
          match: {}
          schema:
            index: 48
            extensions: {}
            elements:
              extension: {index: 49}
              url:
                pattern: {type: Uri, value: primaryReason}
                index: 50
              value:
                short: Reason for amendment, e.g. Safety
                choices: [valueCodeableConcept]
                index: 52
              valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Safety', choiceOf: value, index: 53}
        substantialImpactReliabilityComment:
          match: {}
          schema:
            index: 42
            extensions: {}
            elements:
              extension: {index: 43}
              url:
                pattern: {type: Uri, value: substantialImpactReliabilityComment}
                index: 44
              value:
                short: Comment on substantial impact on reliability
                choices: [valueString]
                index: 46
              valueString: {type: string, short: Comment on substantial impact on reliability, choiceOf: value, index: 47}
        rationale:
          match: {}
          schema:
            index: 18
            extensions: {}
            elements:
              extension: {index: 19}
              url:
                pattern: {type: Uri, value: rationale}
                index: 20
              value:
                short: Rationale
                choices: [valueString]
                index: 22
              valueString: {type: string, short: Rationale, choiceOf: value, index: 23}
        details:
          match: {}
          schema:
            index: 0
            extensions: {}
            elements:
              extension: {index: 1}
              url:
                pattern: {type: Uri, value: details}
                index: 2
              value:
                short: Statement regarding prior amendments
                choices: [valueString]
                index: 4
              valueString: {type: string, short: Statement regarding prior amendments, choiceOf: value, index: 5}
  url:
    pattern: {type: Uri, value: 'http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment'}
    index: 54
  value:
    choices: []
    index: 56
package_version: 1.0.0-ballot2
extensions:
  description:
    url: null
    index: 12
    extensions: {}
    elements:
      extension: {index: 13}
      url:
        pattern: {type: Uri, value: description}
        index: 14
      value:
        short: Description
        choices: [valueString]
        index: 16
      valueString: {type: string, short: Description, choiceOf: value, index: 17}
  substantialImpactSafety:
    url: null
    index: 24
    extensions: {}
    elements:
      extension: {index: 25}
      url:
        pattern: {type: Uri, value: substantialImpactSafety}
        index: 26
      value:
        short: Substantial impact on safety
        choices: [valueBoolean]
        index: 28
      valueBoolean: {type: boolean, short: Substantial impact on safety, choiceOf: value, index: 29}
  substantialImpactReliability:
    url: null
    index: 36
    extensions: {}
    elements:
      extension: {index: 37}
      url:
        pattern: {type: Uri, value: substantialImpactReliability}
        index: 38
      value:
        short: Substantial impact on reliability
        choices: [valueBoolean]
        index: 40
      valueBoolean: {type: boolean, short: Substantial impact on reliability, choiceOf: value, index: 41}
  substantialImpactSafetyComment:
    url: null
    index: 30
    extensions: {}
    elements:
      extension: {index: 31}
      url:
        pattern: {type: Uri, value: substantialImpactSafetyComment}
        index: 32
      value:
        short: Comment on substantial impact on safety
        choices: [valueString]
        index: 34
      valueString: {type: string, short: Comment on substantial impact on safety, choiceOf: value, index: 35}
  scope:
    url: null
    index: 6
    extensions: {}
    elements:
      extension: {index: 7}
      url:
        pattern: {type: Uri, value: scope}
        index: 8
      value:
        short: Global, Coutnry, Region, or Site
        choices: [valueString]
        index: 10
      valueString: {type: string, short: 'Global, Coutnry, Region, or Site', choiceOf: value, index: 11}
  primaryReason:
    url: null
    index: 48
    extensions: {}
    elements:
      extension: {index: 49}
      url:
        pattern: {type: Uri, value: primaryReason}
        index: 50
      value:
        short: Reason for amendment, e.g. Safety
        choices: [valueCodeableConcept]
        index: 52
      valueCodeableConcept: {type: CodeableConcept, short: 'Reason for amendment, e.g. Safety', choiceOf: value, index: 53}
  substantialImpactReliabilityComment:
    url: null
    index: 42
    extensions: {}
    elements:
      extension: {index: 43}
      url:
        pattern: {type: Uri, value: substantialImpactReliabilityComment}
        index: 44
      value:
        short: Comment on substantial impact on reliability
        choices: [valueString]
        index: 46
      valueString: {type: string, short: Comment on substantial impact on reliability, choiceOf: value, index: 47}
  rationale:
    url: null
    index: 18
    extensions: {}
    elements:
      extension: {index: 19}
      url:
        pattern: {type: Uri, value: rationale}
        index: 20
      value:
        short: Rationale
        choices: [valueString]
        index: 22
      valueString: {type: string, short: Rationale, choiceOf: value, index: 23}
  details:
    url: null
    index: 0
    extensions: {}
    elements:
      extension: {index: 1}
      url:
        pattern: {type: Uri, value: details}
        index: 2
      value:
        short: Statement regarding prior amendments
        choices: [valueString]
        index: 4
      valueString: {type: string, short: Statement regarding prior amendments, choiceOf: value, index: 5}
class: extension
kind: complex-type
url: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment
base: http://hl7.org/fhir/StructureDefinition/Extension
version: 1.0.0-ballot2