m11-protocol-amendment
type: StructureDefinition
node role: treeRoot
id:
  v: m11-protocol-amendment
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition m11-protocol-amendment Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Extension 0..* Extension Amendment to a protocol - from EBM #xD; extension 2..* Extension Extension #xD; Slices for extension Content/Rules for all slices #xD; extension:identifier 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "identifier" #xD; value[x] 0..1 Identifier Amendment identifier #xD; extension:previous 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "previous" #xD; value[x] 0..1 CodeableConcept Value of extension Binding: ICH M11 Amendment Details Statement Value Set Terminology (required) #xD; extension:scope S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "scope" #xD; value[x] 0..1 CodeableConcept Global, Not Global Binding: ICH M11 Amendment Scope Value Set Terminology (extensible) #xD; extension:country 0..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "country" #xD; value[x] 0..1 CodeableConcept Value of extension Binding: ICH M11 Study Amendment Country Value Set (extensible) #xD; extension:region 0..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "region" #xD; value[x] 0..1 CodeableConcept Value of extension Binding: ICH M11 Study Amendment Country Value Set (extensible) #xD; extension:site 0..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "site" #xD; value[x] 0..1 Value of extension #xD; valueIdentifier Identifier #xD; valueReference Reference(Any) #xD; extension:approvalDate 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "approvalDate" #xD; value[x] 0..1 date Value of extension #xD; extension:signature 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "signature" #xD; value[x] 0..1 Signature Value of extension #xD; extension:signatureUrl 0..1 Extension Extension #xD; extension 0.…
extension:
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    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics
    l: structuredefinition-type-characteristics
  value: Code
    v: can-bind
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm
    l: structuredefinition-fmm
  value: Integer
    v: 2
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-wg
    l: structuredefinition-wg
  value: Code
    v: brr
extension:
  url:
    v: http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status
    l: structuredefinition-standards-status
  value: Code
    v: trial-use
    extension:
      url:
        v: http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom
        l: structuredefinition-conformance-derivedFrom
      value: Canonical
        v: http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol
        l: hl7.fhir.uv.clinical-study-protocol
url:
  v: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
  l: m11-protocol-amendment
version:
  v: 1.0.0-ballot2
name:
  v: M11_ProtocolAmendment
status:
  v: active
date:
  v: 2026-04-02T08:57:07+00:00
publisher:
  v: HL7 International / Biomedical Research and Regulation
contact:
  name:
    v: HL7 International / Biomedical Research and Regulation
  telecom:
    system:
      v: url
    value:
      v: http://www.hl7.org/Special/committees/rcrim
  telecom:
    system:
      v: email
description:
  v: Amendment to a protocol. This is originally from EBM.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    display:
      v: World
fhir version:
  v: 6.0.0-ballot3
mapping:
  identity:
    v: rim
  uri:
    v: http://hl7.org/v3
    l: v3
  name:
    v: RIM Mapping
kind:
  v: complex-type
abstract:
  v: false
context:
  type:
    v: element
  expression:
    v: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy
type:
  v: Extension
  l: Extension
base definition:
  v: http://hl7.org/fhir/StructureDefinition/Extension
  l: Extension
derivation:
  v: constraint
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      l: snapshot-base-version
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      v: 6.0.0-ballot3
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      v: Amendment to a protocol - from EBM
    definition:
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      expression:
        v: extension.exists() != value.exists()
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        l: Extension
    is modifier:
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Url
v: id
l: id

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rules:
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expression:
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source:
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v: false

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is modifier:
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id:
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path:
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representation:
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definition:
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      l: id
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is modifier:
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is summary:
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mapping:
  identity:
    v: rim
  map:
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id:
  v: Extension.extension:identifier.extension
path:
  v: Extension.extension.extension
slicing:
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    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
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short:
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definition:
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    l: Element
is modifier:
  v: false
is summary:
  v: false

id:
  v: Extension.extension:identifier.url
path:
  v: Extension.extension.url
representation:
  v: xmlAttr
short:
  v: identifies the meaning of the extension
definition:
  v: Source of the definition for the extension code - a logical name or a URL.
comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
min:
  v: 1
max:
  v: 1
base:
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    v: Extension.url
  min:
    v: 1
  max:
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type:
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    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: uri
      l: uri
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
fixed: Uri
  v: identifier
  l: identifier
is modifier:
  v: false
is summary:
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mapping:
  identity:
    v: rim
  map:
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id:
  v: Extension.extension:identifier.value[x]
path:
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short:
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definition:
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    l: Identifier
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    v: error
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    v: All FHIR elements must have a @value or children
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    l: Element
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  v: false
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
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slice name:
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definition:
  v: An Extension
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  expression:
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is modifier:
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is summary:
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id:
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path:
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representation:
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short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
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      v: id
      l: id
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    v: http://hl7.org/fhirpath/System.String
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condition:
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is modifier:
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is summary:
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mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
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path:
  v: Extension.extension.extension
slicing:
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    path:
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short:
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definition:
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base:
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type:
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constraint:
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is modifier:
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is summary:
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id:
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path:
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representation:
  v: xmlAttr
short:
  v: identifies the meaning of the extension
definition:
  v: Source of the definition for the extension code - a logical name or a URL.
comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
min:
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max:
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base:
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  min:
    v: 1
  max:
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type:
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    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      l: structuredefinition-fhir-type
    value: Url
      v: uri
      l: uri
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
fixed: Uri
  v: previous
  l: previous
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:previous.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: Value of extension
definition:
  v: Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).
min:
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max:
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base:
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type:
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    l: CodeableConcept
condition:
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constraint:
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    v: ele-1
  severity:
    v: error
  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
  v: false
is summary:
  v: true
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-details-statement-vs
    l: m11-amendment-details-statement-vs
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:scope
path:
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slice name:
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short:
  v: Extension
definition:
  v: An Extension
min:
  v: 1
max:
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base:
  path:
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  min:
    v: 0
  max:
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type:
  code:
    v: Extension
    l: Extension
constraint:
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    v: ele-1
  severity:
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  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
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must support:
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is modifier:
  v: false
is summary:
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id:
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path:
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representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
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max:
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base:
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      l: id
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condition:
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is modifier:
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is summary:
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mapping:
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  map:
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id:
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path:
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    path:
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  description:
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short:
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definition:
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min:
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max:
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base:
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is modifier:
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is summary:
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id:
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path:
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representation:
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short:
  v: identifies the meaning of the extension
definition:
  v: Source of the definition for the extension code - a logical name or a URL.
comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
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max:
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base:
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  max:
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type:
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fixed: Uri
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is modifier:
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is summary:
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mapping:
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    v: rim
  map:
    v: N/A

id:
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path:
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short:
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definition:
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comment:
  v: If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter global. If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU).
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max:
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type:
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condition:
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constraint:
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    v: error
  human:
    v: All FHIR elements must have a @value or children
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  source:
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    l: Element
is modifier:
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is summary:
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binding:
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    v: extensible
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    v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs
    l: m11-study-amendment-scope-vs
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
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path:
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slice name:
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short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
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base:
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  max:
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type:
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constraint:
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  human:
    v: All FHIR elements must have a @value or children
  expression:
    v: hasValue() or (children().count() > id.count())
  source:
    v: http://hl7.org/fhir/StructureDefinition/Element
    l: Element
is modifier:
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is summary:
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id:
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path:
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representation:
  v: xmlAttr
short:
  v: Unique id for inter-element referencing
definition:
  v: Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
min:
  v: 0
max:
  v: 1
base:
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  min:
    v: 0
  max:
    v: 1
type:
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      l: structuredefinition-fhir-type
    value: Url
      v: id
      l: id
  code:
    v: http://hl7.org/fhirpath/System.String
    l: System.String
condition:
  v: ele-1
is modifier:
  v: false
is summary:
  v: false
mapping:
  identity:
    v: rim
  map:
    v: n/a

id:
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path:
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type:
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id:
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path:
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short:
  v: identifies the meaning of the extension
definition:
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comment:
  v: The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension.
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max:
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base:
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  min:
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  max:
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type:
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    l: System.String
fixed: Uri
  v: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment
  l: m11-protocol-amendment
is modifier:
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is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
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path:
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short:
  v: Value of extension
definition:
  v: Value of extension - must be one of a constrained set of the data types (see [Extensibility](http://build.fhir.org/extensibility.html) for a list).
min:
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max:
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base:
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type:
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type:
  code:
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type:
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    l: canonical
type:
  code:
    v: code
    l: code
type:
  code:
    v: date
    l: date
type:
  code:
    v: dateTime
    l: dateTime
type:
  code:
    v: decimal
    l: decimal
type:
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type:
  code:
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type:
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type:
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type:
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type:
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type:
  code:
    v: string
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type:
  code:
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type:
  code:
    v: unsignedInt
    l: unsignedInt
type:
  code:
    v: uri
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type:
  code:
    v: url
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type:
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    v: uuid
    l: uuid
type:
  code:
    v: Address
    l: Address
type:
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    v: Age
    l: Age
type:
  code:
    v: Annotation
    l: Annotation
type:
  code:
    v: Attachment
    l: Attachment
type:
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type:
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type:
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type:
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    l: ContactPoint
type:
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    v: Count
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type:
  code:
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    l: Distance
type:
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    l: Duration
type:
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    v: HumanName
    l: HumanName
type:
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    v: Identifier
    l: Identifier
type:
  code:
    v: Money
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type:
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type:
  code:
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type:
  code:
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type:
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type:
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type:
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    v: Reference
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type:
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type:
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type:
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type:
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type:
  code:
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    l: DataRequirement
type:
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code:
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code:
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code:
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code:
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  l: UsageContext

code:
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  l: Availability

code:
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code:
  v: Dosage
  l: Dosage

code:
  v: Meta
  l: Meta

v: ext-1

key:
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severity:
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human:
  v: All FHIR elements must have a @value or children
expression:
  v: hasValue() or (children().count() > id.count())
source:
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  l: Element

v: false

v: true

identity:
  v: rim
map:
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element:
  id:
    v: Extension
  path:
    v: Extension
  short:
    v: Amendment to a protocol - from EBM
  definition:
    v: Representation of amendments to a study protocol.
  comment:
    v: The original extension is from EBM and is being modified to separate general amendments (which belong in EBM) and those specific to the UDP use cases.
element:
  id:
    v: Extension.extension
  path:
    v: Extension.extension
  min:
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element:
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    v: identifier
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element:
  id:
    v: Extension.extension:identifier.value[x]
  path:
    v: Extension.extension.value[x]
  short:
    v: Amendment identifier
  definition:
    v: Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page
  type:
    code:
      v: Identifier
      l: Identifier
element:
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element:
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element:
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  type:
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    value set:
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      l: m11-amendment-details-statement-vs
element:
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element:
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    v: scope
    l: scope
element:
  id:
    v: Extension.extension:scope.value[x]
  path:
    v: Extension.extension.value[x]
  short:
    v: Global, Not Global
  definition:
    v: C218673 Global, Country, Region, or Site.
  comment:
    v: If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. If amending a single-country study, enter global. If the amendment does not apply to all sites in the trial, select Not Global and utilize one of the identifiers based on amendment scope. Use the ISO-3166 region or country identifier (for example, DE or EU).
  type:
    code:
      v: CodeableConcept
      l: CodeableConcept
  binding:
    strength:
      v: extensible
    value set:
      v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs
      l: m11-study-amendment-scope-vs
element:
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element:
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element:
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    v: country
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element:
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  path:
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  definition:
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  type:
    code:
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      l: CodeableConcept
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      v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs
      l: m11-country-region-vs
element:
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  max:
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id:
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max:
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id:
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path:
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path:
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definition:
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type:
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    l: CodeableConcept
binding:
  strength:
    v: extensible
  value set:
    v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs
    l: m11-country-region-vs

id:
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path:
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max:
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id:
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path:
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max:
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id:
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path:
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fixed: Uri
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id:
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path:
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definition:
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type:
  code:
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    l: Identifier
type:
  code:
    v: Reference
    l: Reference

id:
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path:
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slice name:
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min:
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max:
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id:
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path:
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max:
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id:
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path:
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fixed: Uri
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id:
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path:
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type:
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    l: date

id:
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max:
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id:
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max:
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id:
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path:
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fixed: Uri
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id:
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path:
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type:
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slice name:
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max:
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id:
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max:
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id:
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path:
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fixed: Uri
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id:
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path:
  v: Extension.extension.value[x]
type:
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    l: string
type:
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    l: url

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path:
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slice name:
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max:
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id:
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path:
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max:
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id:
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path:
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fixed: Uri
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id:
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path:
  v: Extension.extension.value[x]
type:
  code:
    v: string
    l: string

id:
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path:
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slice name:
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min:
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max:
  v: 3
type:
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    l: Extension
  profile:
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    l: m11-amendment-scope-impact
must support:
  v: true

id:
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path:
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slice name:
  v: primaryReason
min:
  v: 0
max:
  v: 1
must support:
  v: true

id:
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path:
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max:
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id:
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path:
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fixed: Uri
  v: primaryReason
  l: primaryReason

id:
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path:
  v: Extension.extension.value[x]
short:
  v: Reason for amendment, e.g. Safety
definition:
  v: Reason for amendment, e.g. Safety.
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
binding:
  strength:
    v: extensible
  value set:
    v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs
    l: m11-study-amendment-reason-vs

id:
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path:
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slice name:
  v: secondaryReason
min:
  v: 0
max:
  v: *
must support:
  v: true

id:
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path:
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max:
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id:
  v: Extension.extension:secondaryReason.url
path:
  v: Extension.extension.url
fixed: Uri
  v: secondaryReason
  l: secondaryReason

id:
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path:
  v: Extension.extension.value[x]
short:
  v: Reason for amendment, e.g. Manufacturing change
definition:
  v: Reason for amendment, e.g. Manufacturing change.
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
binding:
  strength:
    v: extensible
  value set:
    v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs
    l: m11-study-amendment-reason-vs

id:
  v: Extension.extension:summary
path:
  v: Extension.extension
slice name:
  v: summary
min:
  v: 0
max:
  v: 1
must support:
  v: true

id:
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path:
  v: Extension.extension.extension
max:
  v: 0

id:
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path:
  v: Extension.extension.url
fixed: Uri
  v: summary
  l: summary

id:
  v: Extension.extension:summary.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: summary of changes
definition:
  v: Summary of amendmets.
type:
  code:
    v: string
    l: string

id:
  v: Extension.extension:substantialImpactSafety
path:
  v: Extension.extension
slice name:
  v: substantialImpactSafety
min:
  v: 0
max:
  v: 1
must support:
  v: true

id:
  v: Extension.extension:substantialImpactSafety.extension
path:
  v: Extension.extension.extension
max:
  v: 0

id:
  v: Extension.extension:substantialImpactSafety.url
path:
  v: Extension.extension.url
fixed: Uri
  v: substantialImpactSafety
  l: substantialImpactSafety

id:
  v: Extension.extension:substantialImpactSafety.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: Substantial impact on safety
definition:
  v: Substantial impact on safety.
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
binding:
  strength:
    v: required
  value set:
    v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs
    l: m11-yes-no-vs

id:
  v: Extension.extension:substantialImpactSafetyComment
path:
  v: Extension.extension
slice name:
  v: substantialImpactSafetyComment
min:
  v: 0
max:
  v: 1
must support:
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