# Current amendments details - Clinical Study Protocol v1.0.0-ballot2

## Example ResearchStudy: Current amendments details

Language: en

Profile: [M11 Research Study Profile](StructureDefinition-m11-research-study-profile.md)

> **M11 Research Study Extension**
* originalProtocol: Protocol Previously Amended See Summary of Changes Before the Table of Contents
* versionDate: 2017-10-01

> **M11_Approval**
* approvalDate: 2017-10-05
* signature: No display for Signature (data:  )
* signatureUrl: [https://somelocation](https://somelocation)
* signatureMethod: electronic and wet ink copy

> **M11_ProtocolAmendment**
> **url**identifier
**value**: Amendment Identifier/ABC-Exemplar(a)
> **url**previous
**value**: Protocol Previously Amended See Summary of Changes Before the Table of Contents
> **url**scope
**value**: Not Global
> **url**[Country ValueSet](http://hl7.org/fhir/R5/valueset-country.html)
**value**: Germany
> **url**[Country ValueSet](http://hl7.org/fhir/R5/valueset-country.html)
**value**: United Kingdom of Great Britain and Northern Ireland
> **url**region
**value**: New South Wales
> **url**site
**value**: `https://example.org/site-identifier`/exemplarSite-14**scope**: Locally**number**: 234
> **url**[M11_AmendmentScopeImpact](StructureDefinition-m11-amendment-scope-impact.md)
**scope**: Global**number**: 983
> **url**[M11_AmendmentScopeImpact](StructureDefinition-m11-amendment-scope-impact.md)

> **url**primaryReason
**value**: Regulatory Agency Request to Amend Amendment Reason
> **url**secondaryReason
**value**: Manufacturing Change Amendment Reason
> **url**secondaryReason
**value**: Packaging revision
> **url**[summary](http://hl7.org/fhir/R5/codesystem-example-summary.html)
**value**: Manufacturing chanage to enable packaging change to recyclable materials.
> **url**substantialImpactSafety
**value**: Yes
> **url**substantialImpactSafetyComment
**value**: Specifically implemented to decrease safety risks.
> **url**substantialImpactReliability
**value**: No**detail**: Clarification**rationale**: Clarification of synopsis at request of regulator**section**: ICH M11 Protocol Section 1.1 Protocol Synopsis
> **url**[M11_AmendmentDetails](StructureDefinition-m11-amendment-detail.md)
**detail**: Exclusion change**rationale**: Exclude regular drinkers at request of regulator**section**: ICH M11 Protocol Section 5.3 Exclusion Criteria
> **url**[M11_AmendmentDetails](StructureDefinition-m11-amendment-detail.md)
**detail**: Packaging change**rationale**: Change to recyclable packaging (stated in proprietary name).**section**: ICH M11 Protocol Section Title Page
> **url**[M11_AmendmentDetails](StructureDefinition-m11-amendment-detail.md)

> **url**description
**value**: 

#Protocol ABC-Exemplar A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus has been amended. The new protocol is indicated by **Amendment (a)** and will be used to conduct the study in place of any preceding version of the protocol. The overall changes and rationale for the changes made to this protocol are as follows: - An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of fundal hemorrhage induced by hypoglycemia. - The Intravenous Exoticillin GlucaGen reconstitution volume was changed from 1.0 mL to 1.1 mL in accordance with instructions in the Summary of Product Characteristics (2015).


**identifier**: Sponsor Protocol Identifier/ABC-Exemplar (use: usual, )

**version**: (a)

**status**: Active



## Resource Content

```json
{
  "resourceType" : "ResearchStudy",
  "id" : "Exemplar-ResearchStudy-Current-Amendment",
  "meta" : {
    "profile" : ["http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"]
  },
  "language" : "en",
  "extension" : [{
    "extension" : [{
      "url" : "originalProtocol",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C218488",
          "display" : "Protocol Previously Amended See Summary of Changes Before the Table of Contents"
        }]
      }
    },
    {
      "url" : "versionDate",
      "valueDate" : "2017-10-01"
    }],
    "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"
  },
  {
    "extension" : [{
      "url" : "approvalDate",
      "valueDate" : "2017-10-05"
    },
    {
      "url" : "signature",
      "valueSignature" : {
        "data" : " "
      }
    },
    {
      "url" : "signatureUrl",
      "valueUrl" : "https://somelocation"
    },
    {
      "url" : "signatureMethod",
      "valueString" : "electronic and wet ink copy"
    }],
    "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-approval"
  },
  {
    "extension" : [{
      "url" : "identifier",
      "valueIdentifier" : {
        "type" : {
          "text" : "Amendment Identifier"
        },
        "system" : "https://example.org/amendment-identifier",
        "value" : "ABC-Exemplar(a)"
      }
    },
    {
      "url" : "previous",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C218488",
          "display" : "Protocol Previously Amended See Summary of Changes Before the Table of Contents"
        }]
      }
    },
    {
      "url" : "scope",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C217026",
          "display" : "Not Global"
        }]
      }
    },
    {
      "url" : "country",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "urn:iso:std:iso:3166",
          "code" : "DE",
          "display" : "Germany"
        }]
      }
    },
    {
      "url" : "country",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "urn:iso:std:iso:3166",
          "code" : "GB",
          "display" : "United Kingdom of Great Britain and Northern Ireland"
        }]
      }
    },
    {
      "url" : "region",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "urn:iso:std:iso:3166:-2",
          "code" : "AU-NSW",
          "display" : "New South Wales"
        }]
      }
    },
    {
      "url" : "site",
      "valueIdentifier" : {
        "system" : "https://example.org/site-identifier",
        "value" : "exemplarSite-14"
      }
    },
    {
      "extension" : [{
        "url" : "scope",
        "valueCodeableConcept" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C41065",
            "display" : "Locally"
          }]
        }
      },
      {
        "url" : "number",
        "valuePositiveInt" : 234
      }],
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact"
    },
    {
      "extension" : [{
        "url" : "scope",
        "valueCodeableConcept" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C68846",
            "display" : "Global"
          }]
        }
      },
      {
        "url" : "number",
        "valuePositiveInt" : 983
      }],
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-scope-impact"
    },
    {
      "url" : "primaryReason",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C218490",
          "display" : "Regulatory Agency Request to Amend Amendment Reason"
        }]
      }
    },
    {
      "url" : "secondaryReason",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C218494",
          "display" : "Manufacturing Change Amendment Reason"
        }]
      }
    },
    {
      "url" : "secondaryReason",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C17649",
          "display" : "Other"
        }],
        "text" : "Packaging revision"
      }
    },
    {
      "url" : "summary",
      "valueString" : "Manufacturing chanage to enable packaging change to recyclable materials."
    },
    {
      "url" : "substantialImpactSafety",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C49488",
          "display" : "Yes"
        }]
      }
    },
    {
      "url" : "substantialImpactSafetyComment",
      "valueString" : "Specifically implemented to decrease safety risks."
    },
    {
      "url" : "substantialImpactReliability",
      "valueCodeableConcept" : {
        "coding" : [{
          "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
          "code" : "C49487",
          "display" : "No"
        }]
      }
    },
    {
      "extension" : [{
        "url" : "detail",
        "valueString" : "Clarification"
      },
      {
        "url" : "rationale",
        "valueString" : "Clarification of synopsis at request of regulator"
      },
      {
        "url" : "section",
        "valueCodeableConcept" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C218515",
            "display" : "ICH M11 Protocol Section 1.1 Protocol Synopsis"
          }]
        }
      }],
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"
    },
    {
      "extension" : [{
        "url" : "detail",
        "valueString" : "Exclusion change"
      },
      {
        "url" : "rationale",
        "valueString" : "Exclude regular drinkers at request of regulator"
      },
      {
        "url" : "section",
        "valueCodeableConcept" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C218550",
            "display" : "ICH M11 Protocol Section 5.3 Exclusion Criteria"
          }]
        }
      }],
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"
    },
    {
      "extension" : [{
        "url" : "detail",
        "valueString" : "Packaging change"
      },
      {
        "url" : "rationale",
        "valueString" : "Change to recyclable packaging (stated in proprietary name)."
      },
      {
        "url" : "section",
        "valueCodeableConcept" : {
          "coding" : [{
            "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
            "code" : "C222769",
            "display" : "ICH M11 Protocol Section Title Page"
          }]
        }
      }],
      "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-amendment-detail"
    },
    {
      "url" : "description",
      "valueMarkdown" : "#Protocol ABC-Exemplar A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus\n    has been amended.\n    The new protocol is indicated by *Amendment (a)* and will be used to conduct the study in place of any preceding version of the protocol. \n    The overall changes and rationale for the changes made to this protocol are as follows: \n    - An exclusion criterion for patients with retinopathy or maculopathy was added due to the potential risk of \n    fundal hemorrhage induced by hypoglycemia. \n    - The Intravenous Exoticillin GlucaGen reconstitution volume was changed from 1.0 mL to 1.1 mL in accordance with instructions in the Summary of Product Characteristics (2015)."
    }],
    "url" : "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-amendment"
  }],
  "identifier" : [{
    "use" : "usual",
    "type" : {
      "coding" : [{
        "system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
        "code" : "C132351",
        "display" : "Sponsor Protocol Identifier"
      }]
    },
    "system" : "https://exemplarSponsor.com/sponsor-identifier",
    "value" : "ABC-Exemplar"
  }],
  "version" : "(a)",
  "status" : "active"
}

```
