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Packagehl7.fhir.uv.clinical-study-protocol
Resource TypeStructureDefinition
IdStructureDefinition-m11-amendment-scope-impact.json
FHIR VersionR6
Sourcehttps://build.fhir.org/ig/HL7/vulcan-udp-ig/StructureDefinition-m11-amendment-scope-impact.html
URLhttp://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact
Version1.0.0-ballot2
Statusactive
Date2026-06-22T17:54:57+00:00
NameM11_AmendmentScopeImpact
Realmuv
Authorityhl7
DescriptionProvides number or percentage of each group affected by a single amendment
CopyrightPortions 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)
TypeExtension
Kindcomplex-type

Resources that use this resource

StructureDefinition
hl7.fhir.uv.clinical-study-protocol#currentm11-protocol-amendmentM11_ProtocolAmendment

Resources that this resource uses

ValueSet
hl7.fhir.uv.clinical-study-protocol#currentm11-amendment-scope-enrollment-vsICH M11 Amendment Scope Enrollment Description Value Set Terminology

Examples of Use for Extension

ResourceVersion
hl7.fhir.uv.clinical-study-protocol#current:ResearchStudy/Exemplar-ResearchStudy-Current-AmendmentR5

Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: StructureDefinition m11-amendment-scope-impact

NameFlagsCard.TypeDescription & Constraintsdoco
.. Extension 0..*ExtensionExtension
... extension 2..*ExtensionExtension
... Slices for extension Content/Rules for all slices
.... extension:number 1..1ExtensionExtension
..... extension 0..0Extension
..... url 1..1uri"number"
..... value[x] 0..1Number of participants, or % of participants
...... valuePositiveIntpositiveInt
...... valueQuantityQuantity
.... extension:scope 1..1ExtensionExtension
..... extension 0..0Extension
..... url 1..1uri"scope"
..... value[x] 0..1CodeableConceptValue of extension
Binding: ICH M11 Amendment Scope Enrollment Description Value Set Terminology (required)
... url 1..1uri"http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact"
... value[x] 0..0Value of extension

doco Documentation for this format

Source1

{
  "resourceType": "StructureDefinition",
  "id": "m11-amendment-scope-impact",
  "text": {
    "status": "extensions",
    "div": "<!-- snip (see above) -->"
  },
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          }
        ]
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    }
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  "version": "1.0.0-ballot2",
  "name": "M11_AmendmentScopeImpact",
  "status": "active",
  "date": "2026-06-22T17:54:57+00:00",
  "publisher": "HL7 International / Biomedical Research and Regulation",
  "contact": [
    {
      "name": "HL7 International / Biomedical Research and Regulation",
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  "jurisdiction": [
    {
      "coding": [
        {
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          "code": "001",
          "display": "World"
        }
      ]
    }
  ],
  "copyright": "Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. \nThe ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. \n\nCDISC publishes semantics for the ICH M11 protocol data elements and valid \nvalue sets. This terminology set is published and stored in the NCI Thesaurus \nSubset C217023 - ICH M11 Terminology \n(https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) \n\nThe NCI Thesaurus is released under the CC BY 4.0 license\n\nCDISC also publishes the USDM reference architecture which is covered by the CC-BY-4.0 license\n\nFor more licensing information and links see: [licenses.html](licenses.html)",
  "fhirVersion": "6.0.0-ballot3",
  "mapping": [
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      "identity": "rim",
      "uri": "http://hl7.org/v3",
      "name": "RIM Mapping"
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  "kind": "complex-type",
  "abstract": false,
  "context": [
    {
      "type": "extension",
      "expression": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment"
    }
  ],
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  "derivation": "constraint",
  "snapshot": {
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            "source": "http://hl7.org/fhir/StructureDefinition/Element"
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            "key": "ext-1",
            "severity": "error",
            "human": "Must have either extensions or value[x], not both",
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        "isModifier": false
      },
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      },
      {
        "id": "Extension.extension:number.id",
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        "short": "Unique id for inter-element referencing",
        "definition": "Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.",
        "min": 0,
        "max": "1",
        "base": {
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        "type": [
          {
            "extension": [
              {
                "url": "http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type",
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            "code": "http://hl7.org/fhirpath/System.String"
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        ],
        "condition": [
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          {
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      },
      {
        "id": "Extension.extension:number.extension",
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          "discriminator": [
            {
              "type": "value",
              "path": "url"
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          ],
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        "short": "Extension",
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        "min": 0,
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        ],
        "isModifier": false,
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      },
      {
        "id": "Extension.extension:number.url",
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        "comment": "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": 1,
        "max": "1",
        "base": {
          "path": "Extension.url",
          "min": 1,
          "max": "1"
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        "type": [
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            "extension": [
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            "code": "http://hl7.org/fhirpath/System.String"
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        ],
        "fixedUri": "number",
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        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
          }
        ]
      },
      {
        "id": "Extension.extension:number.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Number of participants, or % of participants",
        "definition": "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": 0,
        "max": "1",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
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        "type": [
          {
            "code": "positiveInt"
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          {
            "code": "Quantity"
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        ],
        "condition": [
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        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
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        "min": 0,
        "max": "1",
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          "max": "1"
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        "type": [
          {
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        "condition": [
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        "isModifier": false,
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        "mapping": [
          {
            "identity": "rim",
            "map": "n/a"
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        ]
      },
      {
        "id": "Extension.extension:scope.extension",
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        "slicing": {
          "discriminator": [
            {
              "type": "value",
              "path": "url"
            }
          ],
          "description": "Extensions are always sliced by (at least) url",
          "rules": "open"
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        "short": "Extension",
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        "min": 0,
        "max": "0",
        "base": {
          "path": "Element.extension",
          "min": 0,
          "max": "*"
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        "type": [
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        ],
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            "severity": "error",
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        ],
        "isModifier": false,
        "isSummary": false
      },
      {
        "id": "Extension.extension:scope.url",
        "path": "Extension.extension.url",
        "representation": [
          "xmlAttr"
        ],
        "short": "identifies the meaning of the extension",
        "definition": "Source of the definition for the extension code - a logical name or a URL.",
        "comment": "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": 1,
        "max": "1",
        "base": {
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          "min": 1,
          "max": "1"
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        "type": [
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        "fixedUri": "scope",
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        "isSummary": true,
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        ]
      },
      {
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        "definition": "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": 0,
        "max": "1",
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        "isSummary": true,
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            "identity": "rim",
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      {
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        "short": "identifies the meaning of the extension",
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        "base": {
          "path": "Extension.url",
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          "max": "1"
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        "type": [
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        "fixedUri": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact",
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      },
      {
        "id": "Extension.value[x]",
        "path": "Extension.value[x]",
        "short": "Value of extension",
        "definition": "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": 0,
        "max": "0",
        "base": {
          "path": "Extension.value[x]",
          "min": 0,
          "max": "1"
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        "type": [
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          {
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          {
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          {
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          {
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          {
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          {
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          {
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          {
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          {
            "code": "Money"
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          {
            "code": "Period"
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          {
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          {
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          {
            "code": "Ratio"
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          {
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          {
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          {
            "code": "Signature"
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          {
            "code": "Timing"
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          {
            "code": "ContactDetail"
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          {
            "code": "DataRequirement"
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          {
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          {
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          {
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          {
            "code": "ExtendedContactDetail"
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          {
            "code": "Dosage"
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          {
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        "condition": [
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        "constraint": [
          {
            "key": "ele-1",
            "severity": "error",
            "human": "All FHIR elements must have a @value or children",
            "expression": "hasValue() or (children().count() > id.count())",
            "source": "http://hl7.org/fhir/StructureDefinition/Element"
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        "isModifier": false,
        "isSummary": true,
        "mapping": [
          {
            "identity": "rim",
            "map": "N/A"
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    ]
  },
  "differential": {
    "element": [
      {
        "id": "Extension",
        "path": "Extension",
        "definition": "Provides number or percentage of each group affected by a single amendment"
      },
      {
        "id": "Extension.extension",
        "path": "Extension.extension",
        "min": 2
      },
      {
        "id": "Extension.extension:number",
        "path": "Extension.extension",
        "sliceName": "number",
        "min": 1,
        "max": "1"
      },
      {
        "id": "Extension.extension:number.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:number.url",
        "path": "Extension.extension.url",
        "fixedUri": "number"
      },
      {
        "id": "Extension.extension:number.value[x]",
        "path": "Extension.extension.value[x]",
        "short": "Number of participants, or % of participants",
        "type": [
          {
            "code": "positiveInt"
          },
          {
            "code": "Quantity"
          }
        ]
      },
      {
        "id": "Extension.extension:scope",
        "path": "Extension.extension",
        "sliceName": "scope",
        "min": 1,
        "max": "1"
      },
      {
        "id": "Extension.extension:scope.extension",
        "path": "Extension.extension.extension",
        "max": "0"
      },
      {
        "id": "Extension.extension:scope.url",
        "path": "Extension.extension.url",
        "fixedUri": "scope"
      },
      {
        "id": "Extension.extension:scope.value[x]",
        "path": "Extension.extension.value[x]",
        "type": [
          {
            "code": "CodeableConcept"
          }
        ],
        "binding": {
          "strength": "required",
          "valueSet": "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-amendment-scope-enrollment-vs"
        }
      },
      {
        "id": "Extension.url",
        "path": "Extension.url",
        "fixedUri": "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact"
      },
      {
        "id": "Extension.value[x]",
        "path": "Extension.value[x]",
        "max": "0"
      }
    ]
  }
}