m11-protocol-summary
type: StructureDefinition
node role: treeRoot
id:
  v: m11-protocol-summary
language:
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text:
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    v: extensions
  div:
    v: Generated Narrative: StructureDefinition m11-protocol-summary Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Extension 0..* Extension Summary of a protocol #xD; extension 36..* Extension Extension #xD; Slices for extension Content/Rules for all slices #xD; extension:objectiveAndEstimandSummary S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "objectiveAndEstimandSummary" #xD; value[x] 0..1 C218839 Primary and Secondary Objectives and Estimands #xD; valueMarkdown markdown #xD; valueString string #xD; extension:interventionModel S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "interventionModel" #xD; value[x] 0..1 CodeableConcept C217277 Intervention Model Binding: ICH M11 Intervention Model Value Set Terminology (required) #xD; extension:populationType S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "populationType" #xD; value[x] 0..1 CodeableConcept C217278 Population Type Binding: ICH M11 ... (required) #xD; extension:controlType S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "controlType" #xD; value[x] 0..1 CodeableConcept C217279 Control Type Binding: ICH M11 ... (required) #xD; extension:populationDiagnosisOrCondition S 1..* Extension Extension #xD; url 1..1 uri "populationDiagnosisOrCondition" #xD; extension:comparator 1..* Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "comparator" #xD; value[x] 0..1 Reference(MedicinalProductDefinition) Comparator #xD; extension:minimumAge S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "minimumAge" #xD; value[x] 0..1 Quantity C49693/C25301 Minimum Age value/units #xD; extension:unitsOfMinimumAge S 1..1 Extension Extension #xD; url 1..1 uri "unitsOfMinimumAge" #xD; extension:maximumAge S 1..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "maximumAge" #xD; value[x] 0..1 Quantity C49694/…
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    v: trial-use
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      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:
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  l: m11-protocol-summary
version:
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name:
  v: M11_ProtocolSummary
status:
  v: active
date:
  v: 2026-06-04T16:52:10+00:00
publisher:
  v: HL7 International / Biomedical Research and Regulation
contact:
  name:
    v: HL7 International / Biomedical Research and Regulation
  telecom:
    system:
      v: url
    value:
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  telecom:
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description:
  v: Summary to a protocol.
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    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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v: true

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comment:
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identity:
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id:
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id:
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definition:
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  v: Source of the definition for the extension code - a logical name or a URL.
comment:
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id:
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min:
  v: 0
max:
  v: 0
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
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: false

id:
  v: Extension.extension:trialSchema.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:
  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: trialSchema
  l: trialSchema
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:trialSchema.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: C93682 Trial Schema
definition:
  v: A diagram that outlines the decision points (e.g. randomisation, response evaluation) that define the different paths a participant could take through the trial.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
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
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:schemaNotes
path:
  v: Extension.extension
slice name:
  v: schemaNotes
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 1
max:
  v: 1
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
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: false

id:
  v: Extension.extension:schemaNotes.id
path:
  v: Extension.extension.id
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:
  path:
    v: Element.id
  min:
    v: 0
  max:
    v: 1
type:
  extension:
    url:
      v: http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type
      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:
  v: Extension.extension:schemaNotes.extension
path:
  v: Extension.extension.extension
slicing:
  discriminator:
    type:
      v: value
    path:
      v: url
  description:
    v: Extensions are always sliced by (at least) url
  rules:
    v: open
short:
  v: Extension
definition:
  v: An Extension
min:
  v: 0
max:
  v: 0
base:
  path:
    v: Element.extension
  min:
    v: 0
  max:
    v: *
type:
  code:
    v: Extension
    l: Extension
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: false

id:
  v: Extension.extension:schemaNotes.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:
  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: schemaNotes
  l: schemaNotes
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:schemaNotes.value[x]
path:
  v: Extension.extension.value[x]
short:
  v: C218720 Schema Notes
definition:
  v: A brief written record describing the trial schematic.
min:
  v: 0
max:
  v: 1
base:
  path:
    v: Extension.value[x]
  min:
    v: 0
  max:
    v: 1
type:
  code:
    v: string
    l: string
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