Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2
Clinical Study Protocol, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
{
"resourceType" : "ResearchStudy",
"id" : "Exemplar-ResearchStudy-Current-Amendment",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"
]
},
"language" : "en",
"text" : {
"status" : "extensions",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><p class=\"res-header-id\"><b>Generated Narrative: ResearchStudy Exemplar-ResearchStudy-Current-Amendment</b></p><a name=\"Exemplar-ResearchStudy-Current-Amendment\"> </a><a name=\"hcExemplar-ResearchStudy-Current-Amendment\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-research-study-profile.html\">M11 Research Study Profile</a></p></div><blockquote><p><b>M11 Research Study Extension</b></p><ul><li>originalProtocol: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218488}\">Protocol Previously Amended See Summary of Changes Before the Table of Contents</span></li><li>versionDate: 2017-10-01</li></ul></blockquote><blockquote><p><b>M11_Approval</b></p><ul><li>approvalDate: 2017-10-05</li><li>signature: No display for Signature (data: 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)</li><li>signatureUrl: <a href=\"https://somelocation\">https://somelocation</a></li><li>signatureMethod: electronic and wet ink copy</li></ul></blockquote><blockquote><p><b>M11_ProtocolAmendment</b></p><blockquote><p><b>url</b></p>identifier</blockquote><p><b>value</b>: Amendment Identifier/ABC-Exemplar(a)</p><blockquote><p><b>url</b></p>previous</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218488}\">Protocol Previously Amended See Summary of Changes Before the Table of Contents</span></p><blockquote><p><b>url</b></p>scope</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C217026}\">Not Global</span></p><blockquote><p><b>url</b></p><a href=\"http://hl7.org/fhir/R5/valueset-country.html\">Country ValueSet</a></blockquote><p><b>value</b>: <span title=\"Codes:{urn:iso:std:iso:3166 DE}\">Germany</span></p><blockquote><p><b>url</b></p><a href=\"http://hl7.org/fhir/R5/valueset-country.html\">Country ValueSet</a></blockquote><p><b>value</b>: <span title=\"Codes:{urn:iso:std:iso:3166 GB}\">United Kingdom of Great Britain and Northern Ireland</span></p><blockquote><p><b>url</b></p>region</blockquote><p><b>value</b>: <span title=\"Codes:{urn:iso:std:iso:3166:-2 AU-NSW}\">New South Wales</span></p><blockquote><p><b>url</b></p>site</blockquote><p><b>value</b>: <code>https://example.org/site-identifier</code>/exemplarSite-14</p><p><b>scope</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C41065}\">Locally</span></p><p><b>number</b>: 234</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-m11-amendment-scope-impact.html\">M11_AmendmentScopeImpact</a></blockquote><p><b>scope</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C68846}\">Global</span></p><p><b>number</b>: 983</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-m11-amendment-scope-impact.html\">M11_AmendmentScopeImpact</a></blockquote><blockquote><p><b>url</b></p>primaryReason</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218490}\">Regulatory Agency Request to Amend Amendment Reason</span></p><blockquote><p><b>url</b></p>secondaryReason</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218494}\">Manufacturing Change Amendment Reason</span></p><blockquote><p><b>url</b></p>secondaryReason</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C17649}\">Packaging revision</span></p><blockquote><p><b>url</b></p><a href=\"http://hl7.org/fhir/R5/codesystem-example-summary.html\">summary</a></blockquote><p><b>value</b>: Manufacturing chanage to enable packaging change to recyclable materials.</p><blockquote><p><b>url</b></p>substantialImpactSafety</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C49488}\">Yes</span></p><blockquote><p><b>url</b></p>substantialImpactSafetyComment</blockquote><p><b>value</b>: Specifically implemented to decrease safety risks.</p><blockquote><p><b>url</b></p>substantialImpactReliability</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C49487}\">No</span></p><p><b>detail</b>: Clarification</p><p><b>rationale</b>: Clarification of synopsis at request of regulator</p><p><b>section</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218515}\">ICH M11 Protocol Section 1.1 Protocol Synopsis</span></p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-m11-amendment-detail.html\">M11_AmendmentDetails</a></blockquote><p><b>detail</b>: Exclusion change</p><p><b>rationale</b>: Exclude regular drinkers at request of regulator</p><p><b>section</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218550}\">ICH M11 Protocol Section 5.3 Exclusion Criteria</span></p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-m11-amendment-detail.html\">M11_AmendmentDetails</a></blockquote><p><b>detail</b>: Packaging change</p><p><b>rationale</b>: Change to recyclable packaging (stated in proprietary name).</p><p><b>section</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C222769}\">ICH M11 Protocol Section Title Page</span></p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-m11-amendment-detail.html\">M11_AmendmentDetails</a></blockquote><blockquote><p><b>url</b></p>description</blockquote><p><b>value</b>: </p><div><p>#Protocol ABC-Exemplar A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus\nhas been amended.\nThe new protocol is indicated by <em>Amendment (a)</em> and will be used to conduct the study in place of any preceding version of the protocol.\nThe 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\nfundal 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).</p>\n</div></blockquote><p><b>identifier</b>: Sponsor Protocol Identifier/ABC-Exemplar\u00a0(use:\u00a0usual,\u00a0)</p><p><b>version</b>: (a)</p><p><b>status</b>: Active</p></div>"
},
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"extension" : [
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"url" : "originalProtocol",
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"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
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"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" : {
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}
},
{
"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",
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"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" : [
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"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" : [
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"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"
}
IG © 2026+ HL7 International / Biomedical Research and Regulation.
Package hl7.fhir.uv.clinical-study-protocol#1.0.0-ballot2 based on FHIR 6.0.0-ballot3.
Generated
2026-04-02
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