m11-amendment-detail
type: StructureDefinition
node role: treeRoot
id:
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language:
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text:
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  div:
    v: Generated Narrative: StructureDefinition m11-amendment-detail Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Extension 0..* Extension Extension #xD; extension 3..* Extension Extension #xD; Slices for extension Content/Rules for all slices #xD; extension:detail 1..1 Extension Extension #xD; url 1..1 uri "detail" #xD; extension:rationale 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "rationale" #xD; value[x] 0..1 string Rationale #xD; extension:section 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "section" #xD; value[x] 0..1 CodeableConcept Section where the amendment was made Binding: UDP Section Codes Value Set (required) #xD; url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail" #xD; value[x] 0..0 Value of extension #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
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url:
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version:
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name:
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status:
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date:
  v: 2026-04-09T17:15:23+10:00
publisher:
  v: HL7 International / Biomedical Research and Regulation
contact:
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    v: HL7 International / Biomedical Research and Regulation
  telecom:
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description:
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jurisdiction:
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    code:
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    display:
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copyright:
  v: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license CDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license For more licensing information and links see: [licenses.html](licenses.html)
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id:
  v: Extension.extension:section.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: Section where the amendment was made
definition:
  v: M11 Section where the amendment was made e.g. 1.2 Trial Schema.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
condition:
  v: ext-1
constraint:
  key:
    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/udp-section-codes-vs
    l: udp-section-codes-vs
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.url
path:
  v: 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:
  path:
    v: Extension.url
  min:
    v: 1
  max:
    v: 1
type:
  extension:
    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: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail
  l: m11-amendment-detail
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.value[x]
path:
  v: 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:
  v: 0
max:
  v: 0
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: base64Binary
    l: base64Binary
type:
  code:
    v: boolean
    l: boolean
type:
  code:
    v: canonical
    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:
  code:
    v: id
    l: id
type:
  code:
    v: instant
    l: instant
type:
  code:
    v: integer
    l: integer
type:
  code:
    v: integer64
    l: integer64
type:
  code:
    v: markdown
    l: markdown
type:
  code:
    v: oid
    l: oid
type:
  code:
    v: positiveInt
    l: positiveInt
type:
  code:
    v: string
    l: string
type:
  code:
    v: time
    l: time
type:
  code:
    v: unsignedInt
    l: unsignedInt
type:
  code:
    v: uri
    l: uri
type:
  code:
    v: url
    l: url
type:
  code:
    v: uuid
    l: uuid
type:
  code:
    v: Address
    l: Address
type:
  code:
    v: Age
    l: Age
type:
  code:
    v: Annotation
    l: Annotation
type:
  code:
    v: Attachment
    l: Attachment
type:
  code:
    v: CodeableConcept
    l: CodeableConcept
type:
  code:
    v: CodeableReference
    l: CodeableReference
type:
  code:
    v: Coding
    l: Coding
type:
  code:
    v: ContactPoint
    l: ContactPoint
type:
  code:
    v: Count
    l: Count
type:
  code:
    v: Distance
    l: Distance
type:
  code:
    v: Duration
    l: Duration
type:
  code:
    v: HumanName
    l: HumanName
type:
  code:
    v: Identifier
    l: Identifier
type:
  code:
    v: Money
    l: Money
type:
  code:
    v: Period
    l: Period
type:
  code:
    v: Quantity
    l: Quantity
type:
  code:
    v: Range
    l: Range
type:
  code:
    v: Ratio
    l: Ratio
type:
  code:
    v: RatioRange
    l: RatioRange
type:
  code:
    v: Reference
    l: Reference
type:
  code:
    v: SampledData
    l: SampledData
type:
  code:
    v: Signature
    l: Signature
type:
  code:
    v: Timing
    l: Timing
type:
  code:
    v: ContactDetail
    l: ContactDetail
type:
  code:
    v: DataRequirement
    l: DataRequirement
type:
  code:
    v: Expression
    l: Expression

code:
  v: ParameterDefinition
  l: ParameterDefinition

code:
  v: RelatedArtifact
  l: RelatedArtifact

code:
  v: TriggerDefinition
  l: TriggerDefinition

code:
  v: UsageContext
  l: UsageContext

code:
  v: Availability
  l: Availability

code:
  v: ExtendedContactDetail
  l: ExtendedContactDetail

code:
  v: Dosage
  l: Dosage

code:
  v: Meta
  l: Meta

v: ext-1

key:
  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

v: false

v: true

identity:
  v: rim
map:
  v: N/A

element:
  id:
    v: Extension
  path:
    v: Extension
  definition:
    v: Provides detail of a single amendment - repeats within the overal amendment report
element:
  id:
    v: Extension.extension
  path:
    v: Extension.extension
  min:
    v: 3
element:
  id:
    v: Extension.extension:detail
  path:
    v: Extension.extension
  slice name:
    v: detail
  min:
    v: 1
  max:
    v: 1
element:
  id:
    v: Extension.extension:detail.url
  path:
    v: Extension.extension.url
  fixed: Uri
    v: detail
    l: detail
element:
  id:
    v: Extension.extension:rationale
  path:
    v: Extension.extension
  slice name:
    v: rationale
  min:
    v: 1
  max:
    v: 1
element:
  id:
    v: Extension.extension:rationale.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:rationale.url
  path:
    v: Extension.extension.url
  fixed: Uri
    v: rationale
    l: rationale
element:
  id:
    v: Extension.extension:rationale.value[x]
  path:
    v: Extension.extension.value[x]
  short:
    v: Rationale
  definition:
    v: Rationale.
  type:
    code:
      v: string
      l: string
element:
  id:
    v: Extension.extension:section
  path:
    v: Extension.extension
  slice name:
    v: section
  min:
    v: 1
  max:
    v: 1
element:
  id:
    v: Extension.extension:section.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:section.url
  path:
    v: Extension.extension.url
  fixed: Uri
    v: section
    l: section
element:
  id:
    v: Extension.extension:section.value[x]
  path:
    v: Extension.extension.value[x]
  short:
    v: Section where the amendment was made
  definition:
    v: M11 Section where the amendment was made e.g. 1.2 Trial Schema.
  type:
    code:
      v: CodeableConcept
      l: CodeableConcept
  binding:
    strength:
      v: required
    value set:
      v: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-section-codes-vs
      l: udp-section-codes-vs
element:
  id:
    v: Extension.url
  path:
    v: Extension.url
  fixed: Uri
    v: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail
    l: m11-amendment-detail
element:
  id:
    v: Extension.value[x]
  path:
    v: Extension.value[x]
  max:
    v: 0