m11-approval
type: StructureDefinition
node role: treeRoot
id:
  v: m11-approval
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: StructureDefinition m11-approval Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> Extension C 0..* Extension Sign-off details Constraints: date-required #xD; Slices for extension Content/Rules for all slices #xD; extension:approvalDate S 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 S 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "signatureUrl" #xD; value[x] 0..1 Value of extension #xD; valueString string #xD; valueUrl url #xD; extension:signatureMethod 0..1 Extension Extension #xD; extension 0..0 Extension #xD; url 1..1 uri "signatureMethod" #xD; value[x] 0..1 string Value of extension #xD; url 1..1 uri "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval" #xD; value[x] 0..0 Value of extension #xD; <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
extension:
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    l: structuredefinition-type-characteristics
  value: Code
    v: can-bind
extension:
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    l: structuredefinition-standards-status
  value: Code
    v: trial-use
    extension:
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        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-approval
  l: m11-approval
version:
  v: 1.0.0-ballot2
name:
  v: M11_Approval
status:
  v: active
date:
  v: 2026-04-09T17:15:23+10:00
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: Approval and sign off
jurisdiction:
  coding:
    system:
      v: http://unstats.un.org/unsd/methods/m49/m49.htm
      l: m49.htm
    code:
      v: 001
    display:
      v: World
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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    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:signatureMethod.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:signatureMethod.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: signatureMethod
  l: signatureMethod
is modifier:
  v: false
is summary:
  v: true
mapping:
  identity:
    v: rim
  map:
    v: N/A

id:
  v: Extension.extension:signatureMethod.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:
  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.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-approval
  l: m11-approval
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
  short:
    v: Sign-off details
  definition:
    v: Signature and date for approval.
  comment:
    v: This may need transferring into the StudyDesign profile eventually.
  constraint:
    key:
      v: date-required
    severity:
      v: warning
    human:
      v: At least one of approvalDate or signatureUrl SHOULD be populated.
    expression:
      v: extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()
    source:
      v: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
      l: m11-approval
element:
  id:
    v: Extension.extension:approvalDate
  path:
    v: Extension.extension
  slice name:
    v: approvalDate
  min:
    v: 0
  max:
    v: 1
  must support:
    v: true
element:
  id:
    v: Extension.extension:approvalDate.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:approvalDate.url
  path:
    v: Extension.extension.url
  fixed: Uri
    v: approvalDate
    l: approvalDate
element:
  id:
    v: Extension.extension:approvalDate.value[x]
  path:
    v: Extension.extension.value[x]
  type:
    code:
      v: date
      l: date
element:
  id:
    v: Extension.extension:signature
  path:
    v: Extension.extension
  slice name:
    v: signature
  min:
    v: 0
  max:
    v: 1
element:
  id:
    v: Extension.extension:signature.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:signature.url
  path:
    v: Extension.extension.url
  fixed: Uri
    v: signature
    l: signature
element:
  id:
    v: Extension.extension:signature.value[x]
  path:
    v: Extension.extension.value[x]
  type:
    code:
      v: Signature
      l: Signature
element:
  id:
    v: Extension.extension:signatureUrl
  path:
    v: Extension.extension
  slice name:
    v: signatureUrl
  min:
    v: 0
  max:
    v: 1
  must support:
    v: true
element:
  id:
    v: Extension.extension:signatureUrl.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:signatureUrl.url
  path:
    v: Extension.extension.url
  fixed: Uri
    v: signatureUrl
    l: signatureUrl
element:
  id:
    v: Extension.extension:signatureUrl.value[x]
  path:
    v: Extension.extension.value[x]
  type:
    code:
      v: string
      l: string
  type:
    code:
      v: url
      l: url
element:
  id:
    v: Extension.extension:signatureMethod
  path:
    v: Extension.extension
  slice name:
    v: signatureMethod
  min:
    v: 0
  max:
    v: 1
element:
  id:
    v: Extension.extension:signatureMethod.extension
  path:
    v: Extension.extension.extension
  max:
    v: 0
element:
  id:
    v: Extension.extension:signatureMethod.url
  path:
    v: Extension.extension.url
  fixed: Uri
    v: signatureMethod
    l: signatureMethod
element:
  id:
    v: Extension.extension:signatureMethod.value[x]
  path:
    v: Extension.extension.value[x]
  type:
    code:
      v: string
      l: string
element:
  id:
    v: Extension.url
  path:
    v: Extension.url
  fixed: Uri
    v: http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval
    l: m11-approval
element:
  id:
    v: Extension.value[x]
  path:
    v: Extension.value[x]
  max:
    v: 0