research-study-study-amendment
type: StructureDefinition
node role: treeRoot
id:
  v: research-study-study-amendment
language:
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text:
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    v: extensions
  div:
    v: Generated Narrative: StructureDefinition research-study-study-amendment Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Extension 0..* Extension An amendment to a study protocol #xD; Slices for extension Content/Rules for all slices #xD; extension:details 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "details" #xD; value[x] 0..1 string Statement regarding prior amendments #xD; extension:scope 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "scope" #xD; value[x] 0..1 string Global, Coutnry, Region, or Site #xD; extension:description 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "description" #xD; value[x] 0..1 string Description #xD; extension:rationale 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "rationale" #xD; value[x] 0..1 string Rationale #xD; extension:substantialImpactSafety 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactSafety" #xD; value[x] 0..1 boolean Substantial impact on safety #xD; extension:substantialImpactSafetyComment 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactSafetyComment" #xD; value[x] 0..1 string Comment on substantial impact on safety #xD; extension:substantialImpactReliability 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactReliability" #xD; value[x] 0..1 boolean Substantial impact on reliability #xD; extension:substantialImpactReliabilityComment 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "substantialImpactReliabilityComment" #xD; value[x] 0..1 string Comment on substantial impact on reliability #xD; extension:primaryReason 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "primaryReason" #xD; value[x] 0..1 CodeableConcept Reason for amendment, e.g. Safety #xD; url 1..1 uri "http://hl7.or…
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url:
  v: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-study-amendment
  l: research-study-study-amendment
identifier:
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    v: urn:ietf:rfc:3986
    l: 3986
  value:
    v: urn:oid:2.16.840.1.113883.4.642.40.44.42.97
version:
  v: 1.0.0-ballot3
name:
  v: ResearchStudyStudyAmendment
status:
  v: active
date:
  v: 2026-03-27T09:54:14+00:00
publisher:
  v: HL7 International / Clinical Decision Support
contact:
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    v: HL7 International / Clinical Decision Support
  telecom:
    system:
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    value:
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jurisdiction:
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    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
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      v: 001
    display:
      v: World
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