# M11_Approval - Clinical Study Protocol v1.0.0-ballot2

## Extension: 

Approval and sign off

**Context of Use**

### Must Support Elements

§At least one of approvalDate or signatureUrl SHOULD be populated§

**Usage info**

**Usages:**

* Use this Extension: [M11 Research Study Profile](StructureDefinition-m11-research-study-profile.md)
* Examples for this Extension: [ResearchStudy/Exemplar-ResearchStudy-001](ResearchStudy-Exemplar-ResearchStudy-001.md) and [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-approval)

### 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-approval.csv), [Excel](../StructureDefinition-m11-approval.xlsx), [Schematron](../StructureDefinition-m11-approval.sch) 



## Resource Content

```json
{
  "resourceType" : "StructureDefinition",
  "id" : "m11-approval",
  "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-approval",
  "version" : "1.0.0-ballot2",
  "name" : "M11_Approval",
  "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" : "Approval and sign off",
  "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" : "Sign-off details",
      "definition" : "Signature and date for approval.",
      "comment" : "This may need transferring into the StudyDesign profile eventually.",
      "constraint" : [{
        "key" : "date-required",
        "severity" : "warning",
        "human" : "At least one of approvalDate or signatureUrl SHOULD be populated.",
        "expression" : "extension.where(url = 'approvalDate').exists() or extension.where(url = 'signatureUrl').exists()",
        "source" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
      }]
    },
    {
      "id" : "Extension.extension:approvalDate",
      "path" : "Extension.extension",
      "sliceName" : "approvalDate",
      "min" : 0,
      "max" : "1",
      "mustSupport" : true
    },
    {
      "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",
      "mustSupport" : true
    },
    {
      "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.url",
      "path" : "Extension.url",
      "fixedUri" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
    },
    {
      "id" : "Extension.value[x]",
      "path" : "Extension.value[x]",
      "max" : "0"
    }]
  }
}

```
