# M11_ProtocolAmendment - Clinical Study Protocol v1.0.0-ballot2

## Extension: 

Amendment to a protocol. This is originally from EBM.

**Context of Use**

**Usage info**

**Usages:**

* Use this Extension: [M11 Research Study Profile](StructureDefinition-m11-research-study-profile.md)
* Examples for this Extension: [ResearchStudy/Exemplar-ResearchStudy-Current-Amendment](ResearchStudy-Exemplar-ResearchStudy-Current-Amendment.md)

You can also check for [usages in the FHIR IG Statistics](https://packages2.fhir.org/xig/hl7.fhir.uv.clinical-study-protocol|current/StructureDefinition/m11-protocol-amendment)

### Formal Views of Extension Content

 [Description Differentials, Snapshots, and other representations](http://build.fhir.org/ig/FHIR/ig-guidance/readingIgs.html#structure-definitions). 

 

Other representations of profile: [CSV](../StructureDefinition-m11-protocol-amendment.csv), [Excel](../StructureDefinition-m11-protocol-amendment.xlsx), [Schematron](../StructureDefinition-m11-protocol-amendment.sch) 



## Resource Content

```json
{
  "resourceType" : "StructureDefinition",
  "id" : "m11-protocol-amendment",
  "extension" : [{
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-type-characteristics",
    "valueCode" : "can-bind"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm",
    "valueInteger" : 2
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg",
    "valueCode" : "brr"
  },
  {
    "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status",
    "valueCode" : "trial-use",
    "_valueCode" : {
      "extension" : [{
        "url" : "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom",
        "valueCanonical" : "http://hl7.org/fhir/uv/clinical-study-protocol/ImplementationGuide/hl7.fhir.uv.clinical-study-protocol"
      }]
    }
  }],
  "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment",
  "version" : "1.0.0-ballot2",
  "name" : "M11_ProtocolAmendment",
  "status" : "active",
  "date" : "2026-04-09T17:15:23+10:00",
  "publisher" : "HL7 International / Biomedical Research and Regulation",
  "contact" : [{
    "name" : "HL7 International / Biomedical Research and Regulation",
    "telecom" : [{
      "system" : "url",
      "value" : "http://www.hl7.org/Special/committees/rcrim"
    },
    {
      "system" : "email",
      "value" : "UDP@HL7Vulcan.org"
    }]
  }],
  "description" : "Amendment to a protocol. This is originally from EBM.",
  "jurisdiction" : [{
    "coding" : [{
      "system" : "http://unstats.un.org/unsd/methods/m49/m49.htm",
      "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" : [{
    "identity" : "rim",
    "uri" : "http://hl7.org/v3",
    "name" : "RIM Mapping"
  }],
  "kind" : "complex-type",
  "abstract" : false,
  "context" : [{
    "type" : "element",
    "expression" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile#ResearchStudy"
  }],
  "type" : "Extension",
  "baseDefinition" : "http://hl7.org/fhir/StructureDefinition/Extension",
  "derivation" : "constraint",
  "differential" : {
    "element" : [{
      "id" : "Extension",
      "path" : "Extension",
      "short" : "Amendment to a protocol - from EBM",
      "definition" : "Representation of amendments to a study protocol.",
      "comment" : "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."
    },
    {
      "id" : "Extension.extension",
      "path" : "Extension.extension",
      "min" : 2
    },
    {
      "id" : "Extension.extension:identifier",
      "path" : "Extension.extension",
      "sliceName" : "identifier",
      "min" : 1,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:identifier.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:identifier.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "identifier"
    },
    {
      "id" : "Extension.extension:identifier.value[x]",
      "path" : "Extension.extension.value[x]",
      "short" : "Amendment identifier",
      "definition" : "Identifier for this amendment - if it is the current amendment the identifier is repeated from the title page",
      "type" : [{
        "code" : "Identifier"
      }]
    },
    {
      "id" : "Extension.extension:previous",
      "path" : "Extension.extension",
      "sliceName" : "previous",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:previous.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:previous.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "previous"
    },
    {
      "id" : "Extension.extension:previous.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-details-statement-vs"
      }
    },
    {
      "id" : "Extension.extension:scope",
      "path" : "Extension.extension",
      "sliceName" : "scope",
      "min" : 1,
      "max" : "1",
      "mustSupport" : true
    },
    {
      "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]",
      "short" : "Global, Not Global",
      "definition" : "C218673 Global, Country, Region, or Site.",
      "comment" : "If an amendment applies to all sites in the trial, enter Global and delete the Country, Region and Site Identifier fields. \n  If amending a single-country study, enter global. \n  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. \n  Use the ISO-3166 region or country identifier (for example, DE or EU).",
      "type" : [{
        "code" : "CodeableConcept"
      }],
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-scope-vs"
      }
    },
    {
      "id" : "Extension.extension:country",
      "path" : "Extension.extension",
      "sliceName" : "country",
      "min" : 0,
      "max" : "*"
    },
    {
      "id" : "Extension.extension:country.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:country.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "country"
    },
    {
      "id" : "Extension.extension:country.value[x]",
      "path" : "Extension.extension.value[x]",
      "definition" : "C20108",
      "type" : [{
        "code" : "CodeableConcept"
      }],
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"
      }
    },
    {
      "id" : "Extension.extension:region",
      "path" : "Extension.extension",
      "sliceName" : "region",
      "min" : 0,
      "max" : "*"
    },
    {
      "id" : "Extension.extension:region.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:region.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "region"
    },
    {
      "id" : "Extension.extension:region.value[x]",
      "path" : "Extension.extension.value[x]",
      "definition" : "C218674",
      "type" : [{
        "code" : "CodeableConcept"
      }],
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-country-region-vs"
      }
    },
    {
      "id" : "Extension.extension:site",
      "path" : "Extension.extension",
      "sliceName" : "site",
      "min" : 0,
      "max" : "*"
    },
    {
      "id" : "Extension.extension:site.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:site.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "site"
    },
    {
      "id" : "Extension.extension:site.value[x]",
      "path" : "Extension.extension.value[x]",
      "definition" : "C83081",
      "type" : [{
        "code" : "Identifier"
      },
      {
        "code" : "Reference"
      }]
    },
    {
      "id" : "Extension.extension:approvalDate",
      "path" : "Extension.extension",
      "sliceName" : "approvalDate",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:approvalDate.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:approvalDate.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "approvalDate"
    },
    {
      "id" : "Extension.extension:approvalDate.value[x]",
      "path" : "Extension.extension.value[x]",
      "type" : [{
        "code" : "date"
      }]
    },
    {
      "id" : "Extension.extension:signature",
      "path" : "Extension.extension",
      "sliceName" : "signature",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:signature.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:signature.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "signature"
    },
    {
      "id" : "Extension.extension:signature.value[x]",
      "path" : "Extension.extension.value[x]",
      "type" : [{
        "code" : "Signature"
      }]
    },
    {
      "id" : "Extension.extension:signatureUrl",
      "path" : "Extension.extension",
      "sliceName" : "signatureUrl",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:signatureUrl.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:signatureUrl.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "signatureUrl"
    },
    {
      "id" : "Extension.extension:signatureUrl.value[x]",
      "path" : "Extension.extension.value[x]",
      "type" : [{
        "code" : "string"
      },
      {
        "code" : "url"
      }]
    },
    {
      "id" : "Extension.extension:signatureMethod",
      "path" : "Extension.extension",
      "sliceName" : "signatureMethod",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:signatureMethod.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:signatureMethod.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "signatureMethod"
    },
    {
      "id" : "Extension.extension:signatureMethod.value[x]",
      "path" : "Extension.extension.value[x]",
      "type" : [{
        "code" : "string"
      }]
    },
    {
      "id" : "Extension.extension:scopeImpact",
      "path" : "Extension.extension",
      "sliceName" : "scopeImpact",
      "min" : 0,
      "max" : "3",
      "type" : [{
        "code" : "Extension",
        "profile" : ["http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact"]
      }],
      "mustSupport" : true
    },
    {
      "id" : "Extension.extension:primaryReason",
      "path" : "Extension.extension",
      "sliceName" : "primaryReason",
      "min" : 0,
      "max" : "1",
      "mustSupport" : true
    },
    {
      "id" : "Extension.extension:primaryReason.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:primaryReason.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "primaryReason"
    },
    {
      "id" : "Extension.extension:primaryReason.value[x]",
      "path" : "Extension.extension.value[x]",
      "short" : "Reason for amendment, e.g. Safety",
      "definition" : "Reason for amendment, e.g. Safety.",
      "type" : [{
        "code" : "CodeableConcept"
      }],
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs"
      }
    },
    {
      "id" : "Extension.extension:secondaryReason",
      "path" : "Extension.extension",
      "sliceName" : "secondaryReason",
      "min" : 0,
      "max" : "*",
      "mustSupport" : true
    },
    {
      "id" : "Extension.extension:secondaryReason.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:secondaryReason.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "secondaryReason"
    },
    {
      "id" : "Extension.extension:secondaryReason.value[x]",
      "path" : "Extension.extension.value[x]",
      "short" : "Reason for amendment, e.g. Manufacturing change",
      "definition" : "Reason for amendment, e.g. Manufacturing change.",
      "type" : [{
        "code" : "CodeableConcept"
      }],
      "binding" : {
        "strength" : "extensible",
        "valueSet" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs"
      }
    },
    {
      "id" : "Extension.extension:summary",
      "path" : "Extension.extension",
      "sliceName" : "summary",
      "min" : 0,
      "max" : "1",
      "mustSupport" : true
    },
    {
      "id" : "Extension.extension:summary.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:summary.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "summary"
    },
    {
      "id" : "Extension.extension:summary.value[x]",
      "path" : "Extension.extension.value[x]",
      "short" : "summary of changes",
      "definition" : "Summary of amendmets.",
      "type" : [{
        "code" : "string"
      }]
    },
    {
      "id" : "Extension.extension:substantialImpactSafety",
      "path" : "Extension.extension",
      "sliceName" : "substantialImpactSafety",
      "min" : 0,
      "max" : "1",
      "mustSupport" : true
    },
    {
      "id" : "Extension.extension:substantialImpactSafety.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:substantialImpactSafety.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "substantialImpactSafety"
    },
    {
      "id" : "Extension.extension:substantialImpactSafety.value[x]",
      "path" : "Extension.extension.value[x]",
      "short" : "Substantial impact on safety",
      "definition" : "Substantial impact on safety.",
      "type" : [{
        "code" : "CodeableConcept"
      }],
      "binding" : {
        "strength" : "required",
        "valueSet" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
      }
    },
    {
      "id" : "Extension.extension:substantialImpactSafetyComment",
      "path" : "Extension.extension",
      "sliceName" : "substantialImpactSafetyComment",
      "min" : 0,
      "max" : "1",
      "mustSupport" : true
    },
    {
      "id" : "Extension.extension:substantialImpactSafetyComment.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:substantialImpactSafetyComment.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "substantialImpactSafetyComment"
    },
    {
      "id" : "Extension.extension:substantialImpactSafetyComment.value[x]",
      "path" : "Extension.extension.value[x]",
      "short" : "Comment on substantial impact on safety",
      "definition" : "Comment on substantial impact on safety.",
      "type" : [{
        "code" : "string"
      }]
    },
    {
      "id" : "Extension.extension:substantialImpactReliability",
      "path" : "Extension.extension",
      "sliceName" : "substantialImpactReliability",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:substantialImpactReliability.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:substantialImpactReliability.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "substantialImpactReliability"
    },
    {
      "id" : "Extension.extension:substantialImpactReliability.value[x]",
      "path" : "Extension.extension.value[x]",
      "short" : "Substantial impact on reliability",
      "definition" : "Substantial impact on reliability.",
      "type" : [{
        "code" : "CodeableConcept"
      }],
      "binding" : {
        "strength" : "required",
        "valueSet" : "http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-yes-no-vs"
      }
    },
    {
      "id" : "Extension.extension:substantialImpactReliabilityComment",
      "path" : "Extension.extension",
      "sliceName" : "substantialImpactReliabilityComment",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:substantialImpactReliabilityComment.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:substantialImpactReliabilityComment.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "substantialImpactReliabilityComment"
    },
    {
      "id" : "Extension.extension:substantialImpactReliabilityComment.value[x]",
      "path" : "Extension.extension.value[x]",
      "short" : "Comment on substantial impact on reliability",
      "definition" : "Comment on substantial impact on reliability.",
      "type" : [{
        "code" : "string"
      }]
    },
    {
      "id" : "Extension.extension:details",
      "path" : "Extension.extension",
      "sliceName" : "details",
      "min" : 0,
      "max" : "*",
      "type" : [{
        "code" : "Extension",
        "profile" : ["http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"]
      }],
      "mustSupport" : true
    },
    {
      "id" : "Extension.extension:rationale",
      "path" : "Extension.extension",
      "sliceName" : "rationale",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:rationale.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:rationale.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "rationale"
    },
    {
      "id" : "Extension.extension:rationale.value[x]",
      "path" : "Extension.extension.value[x]",
      "type" : [{
        "code" : "string"
      }]
    },
    {
      "id" : "Extension.extension:description",
      "path" : "Extension.extension",
      "sliceName" : "description",
      "min" : 0,
      "max" : "1"
    },
    {
      "id" : "Extension.extension:description.extension",
      "path" : "Extension.extension.extension",
      "max" : "0"
    },
    {
      "id" : "Extension.extension:description.url",
      "path" : "Extension.extension.url",
      "fixedUri" : "description"
    },
    {
      "id" : "Extension.extension:description.value[x]",
      "path" : "Extension.extension.value[x]",
      "type" : [{
        "code" : "markdown"
      },
      {
        "code" : "string"
      }]
    },
    {
      "id" : "Extension.url",
      "path" : "Extension.url",
      "fixedUri" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment"
    },
    {
      "id" : "Extension.value[x]",
      "path" : "Extension.value[x]",
      "max" : "0"
    }]
  }
}

```
