Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot
Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot
Pharmaceutical Research Protocol (Vulcan UDP), 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-ballot 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
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@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdf: <http://www.w3.org/1999/02/22-rdf-syntax-ns#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix sct: <http://snomed.info/id/> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:ResearchStudy ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "IGBJ-ResearchStudy"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-profile"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/m11-research-study-profile> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ResearchStudy IGBJ-ResearchStudy</b></p><a name=\"IGBJ-ResearchStudy\"> </a><a name=\"hcIGBJ-ResearchStudy\"> </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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-m11-research-study-profile.html\">M11 Research Study</a></p></div><p><b>Narrative Elements</b>: <a href=\"Composition-IGBJ-Narrative-1.3.html\">Composition IGBJ Protocol Narrative 1.3</a></p><p><b>Narrative Elements</b>: <a href=\"Composition-IGBJ-Narrative-2.1.html\">Composition IGBJ Protocol Narrative 2.1</a></p><p><b>Narrative Elements</b>: <a href=\"Composition-IGBJ-Narrative-5.1.html\">Composition IGBJ Protocol Narrative 5.1</a></p><p><b>Narrative Elements</b>: <a href=\"Composition-IGBJ-Narrative-9.html\">Composition IGBJ Protocol Narrative 9</a></p><blockquote><p><b>M11_ProtocolAmendment</b></p><blockquote><p><b>url</b></p>scope</blockquote><p><b>value</b>: C217026</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>: DE</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>: GB</p><blockquote><p><b>url</b></p>region</blockquote><p><b>value</b>: AU-NSW</p><blockquote><p><b>url</b></p>site</blockquote><p><b>value</b>: <code>https://example.org/site-identifier</code>/sss</p><blockquote><p><b>url</b></p>approvalDate</blockquote><p><b>value</b>: 2017-12-05</p><blockquote><p><b>url</b></p>signature</blockquote><p><b>value</b>: No display for Signature (data: 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)</p><blockquote><p><b>url</b></p>signatureURL</blockquote><p><b>value</b>: https://somelocation</p><blockquote><p><b>url</b></p>signatureMethod</blockquote><p><b>value</b>: electronic and wet ink copy</p><p><b>scope</b>: C41065</p><p><b>number</b>: 234</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-ResearchStudyStudyAmendmentScopeImpact.html\">ResearchStudyStudyAmendmentScopeImpact</a></blockquote><p><b>scope</b>: C68846</p><p><b>number</b>: 983</p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-ResearchStudyStudyAmendmentScopeImpact.html\">ResearchStudyStudyAmendmentScopeImpact</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</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</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>: Regulator required manufacturing chanage.</p><blockquote><p><b>url</b></p>substantialImpactSafety</blockquote><p><b>value</b>: C49488</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>: C17998</p><blockquote><p><b>url</b></p>substantialImpactReliabilityComment</blockquote><p><b>value</b>: ccc</p><p><b>detail</b>: amendment one</p><p><b>rationale</b>: clarification</p><p><b>section</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218515}\">1.1 Protocol Synopsis</span></p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-protocol-amendment-detail.html\">ResearchStudyStudyAmendmentDetails</a></blockquote><p><b>detail</b>: amendment two</p><p><b>rationale</b>: exclude regular drinkers</p><p><b>section</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218550}\">5.3 Exclusion Criteria</span></p><blockquote><p><b>url</b></p><a href=\"StructureDefinition-protocol-amendment-detail.html\">ResearchStudyStudyAmendmentDetails</a></blockquote><blockquote><p><b>url</b></p>rationale</blockquote><p><b>value</b>: Updates to address safety concern & align with product guidelines.</p><blockquote><p><b>url</b></p>description</blockquote><p><b>value</b>: Protocol I8R-JE-IGBJ A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with 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 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></blockquote><p><b>ResearchStudySponsorConfidentialityStatement</b>: All data is confidential</p><p><b>identifier</b>: Regulatory Agency Identifier/NCT03421379 (use: official, ), Sponsor Identifier/I8R-JE-IGBJ (use: usual, ), Amendment Identifier/I8R-JE-IGBJ(a) (use: usual, )</p><p><b>version</b>: (a)</p><p><b>title</b>: A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus</p><h3>Labels</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/title-type short-title}\">Short title</span></td><td>A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus</td></tr></table><p><b>date</b>: 2017-12-05</p><p><b>status</b>: Draft</p><p><b>phase</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C15602}\">Phase 3</span></p><h3>Focus</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"MedicinalProductDefinition-IGBJ-MedicinalProduct.html\">MedicinalProductDefinition: identifier = Sponsor Investigational Product Code: LY900018</a></td></tr></table><p><b>condition</b>: <span title=\"Codes:{http://snomed.info/sct 1137328006}\">Iatrogenic hypoglycaemia</span></p></div>"^^rdf:XMLLiteral ] ; # fhir:extension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "Composition/IGBJ-Narrative-1.3" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "Composition/IGBJ-Narrative-2.1" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "Composition/IGBJ-Narrative-5.1" ] ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/narrative-elements"^^xsd:anyURI ] ; fhir:value [ a fhir:Reference ; fhir:reference [ fhir:v "Composition/IGBJ-Narrative-9" ] ] ] [ ( fhir:extension [ fhir:url [ fhir:v "scope"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "C217026" ] ] [ fhir:url [ fhir:v "country"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "DE" ] ] [ fhir:url [ fhir:v "country"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "GB" ] ] [ fhir:url [ fhir:v "region"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "AU-NSW" ] ] [ fhir:url [ fhir:v "site"^^xsd:anyURI ] ; fhir:value [ a fhir:Identifier ; fhir:system [ fhir:v "https://example.org/site-identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "sss" ] ] ] [ fhir:url [ fhir:v "approvalDate"^^xsd:anyURI ] ; fhir:value [ a fhir:date ; fhir:v "2017-12-05"^^xsd:date ] ] [ fhir:url [ fhir:v "signature"^^xsd:anyURI ] ; fhir:value [ a fhir:Signature ; fhir:data [ fhir:v "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"^^xsd:base64Binary ] ] ] [ fhir:url [ fhir:v "signatureURL"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "https://somelocation" ] ] [ fhir:url [ fhir:v "signatureMethod"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "electronic and wet ink copy" ] ] [ ( fhir:extension [ fhir:url [ fhir:v "scope"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "C41065" ] ] [ fhir:url [ fhir:v "number"^^xsd:anyURI ] ; fhir:value [ a fhir:positiveInt ; fhir:v "234"^^xsd:positiveInteger ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact"^^xsd:anyURI ] ] [ ( fhir:extension [ fhir:url [ fhir:v "scope"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "C68846" ] ] [ fhir:url [ fhir:v "number"^^xsd:anyURI ] ; fhir:value [ a fhir:positiveInt ; fhir:v "983"^^xsd:positiveInteger ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/ResearchStudyStudyAmendmentScopeImpact"^^xsd:anyURI ] ] [ fhir:url [ fhir:v "primaryReason"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C218490" ] ; fhir:display [ fhir:v "Regulatory Agency Request To Amend" ] ] ) ] ] [ fhir:url [ fhir:v "secondaryReason"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C218494" ] ; fhir:display [ fhir:v "Manufacturing Change" ] ] ) ] ] [ fhir:url [ fhir:v "summary"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "Regulator required manufacturing chanage." ] ] [ fhir:url [ fhir:v "substantialImpactSafety"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "C49488" ] ] [ fhir:url [ fhir:v "substantialImpactSafetyComment"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "Specifically implemented to decrease safety risks." ] ] [ fhir:url [ fhir:v "substantialImpactReliability"^^xsd:anyURI ] ; fhir:value [ a fhir:code ; fhir:v "C17998" ] ] [ fhir:url [ fhir:v "substantialImpactReliabilityComment"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "ccc" ] ] [ ( fhir:extension [ fhir:url [ fhir:v "detail"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "amendment one" ] ] [ fhir:url [ fhir:v "rationale"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "clarification" ] ] [ fhir:url [ fhir:v "section"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C218515" ] ; fhir:display [ fhir:v "1.1 Protocol Synopsis" ] ] ) ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"^^xsd:anyURI ] ] [ ( fhir:extension [ fhir:url [ fhir:v "detail"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "amendment two" ] ] [ fhir:url [ fhir:v "rationale"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "exclude regular drinkers" ] ] [ fhir:url [ fhir:v "section"^^xsd:anyURI ] ; fhir:value [ a fhir:CodeableConcept ; ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C218550" ] ; fhir:display [ fhir:v "5.3 Exclusion Criteria" ] ] ) ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment-detail"^^xsd:anyURI ] ] [ fhir:url [ fhir:v "rationale"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "Updates to address safety concern & align with product guidelines." ] ] [ fhir:url [ fhir:v "description"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "Protocol I8R-JE-IGBJ A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with 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 GlucaGen reconstitution volume was changed from 1.0 mL to 1.1 mL in accordance with instructions in the Summary of Product Characteristics (2015)." ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/pharmaceutical-research-protocol/StructureDefinition/protocol-amendment"^^xsd:anyURI ] ] [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-sponsor-confidentiality-statement"^^xsd:anyURI ] ; fhir:value [ a fhir:string ; fhir:v "All data is confidential" ] ] ) ; # fhir:identifier ( [ fhir:use [ fhir:v "official" ] ; fhir:type [ fhir:text [ fhir:v "Regulatory Agency Identifier" ] ] ; fhir:system [ fhir:v "https://example.org/regulatory-agency-identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "NCT03421379" ] ] [ fhir:use [ fhir:v "usual" ] ; fhir:type [ fhir:text [ fhir:v "Sponsor Identifier" ] ] ; fhir:system [ fhir:v "https://example.org/sponsor-identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "I8R-JE-IGBJ" ] ] [ fhir:use [ fhir:v "usual" ] ; fhir:type [ fhir:text [ fhir:v "Amendment Identifier" ] ] ; fhir:system [ fhir:v "https://example.org/amendment-identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "I8R-JE-IGBJ(a)" ] ] ) ; # fhir:version [ fhir:v "(a)"] ; # fhir:title [ fhir:v "A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus"] ; # fhir:label ( [ fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/title-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "short-title" ] ; fhir:display [ fhir:v "Short title" ] ] ) ] ; fhir:value [ fhir:v "A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients with Diabetes Mellitus" ] ] ) ; # fhir:date [ fhir:v "2017-12-05"^^xsd:date] ; # fhir:status [ fhir:v "draft"] ; # fhir:phase [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C15602" ] ; fhir:display [ fhir:v "Phase 3" ] ] ) ] ; # fhir:focus ( [ fhir:reference [ fhir:reference [ fhir:v "MedicinalProductDefinition/IGBJ-MedicinalProduct" ] ] ] ) ; # fhir:condition ( [ ( fhir:coding [ a sct:1137328006 ; fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ; fhir:code [ fhir:v "1137328006" ] ; fhir:display [ fhir:v "Iatrogenic hypoglycaemia" ] ] ) ] ) . #
IG © 2025+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.pharmaceutical-research-protocol#1.0.0-ballot based on FHIR 6.0.0-ballot3. Generated 2025-07-31
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