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-001",
"meta" : {
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🔗 "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"
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"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-001</b></p><a name=\"Exemplar-ResearchStudy-001\"> </a><a name=\"hcExemplar-ResearchStudy-001\"> </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><p><b>M11_ConfidentialityStatement</b>: All data is confidential</p><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><p><b>Narrative Elements</b>: <a href=\"Composition-Exemplar-Narrative.html\">Composition Exemplar Protocol Narratives</a></p><p><b>Narrative Elements</b>: <a href=\"Composition-Exemplar-Narrative-2.1.html\">Composition Exemplar Protocol Narrative 2.1</a></p><p><b>identifier</b>: Sponsor Protocol Identifier/ABC-Exemplar, EU CT Number/EU-1234, Other Regulatory or Clinical Trial Identifier/ERA1234, Amendment Identifier/ABC-Exemplar(a)</p><p><b>version</b>: (a)</p><p><b>title</b>: A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus</p><blockquote><p><b>label</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C207646}\">Study Acronym</span></p><p><b>value</b>: Inhaled vs IM Exoticillin</p></blockquote><blockquote><p><b>label</b></p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C207615}\">Brief Study Title</span></p><p><b>value</b>: A Phase 3 Study of Inhaled versus Intramuscular Exoticillin for Bronchtis in Diabetic Japanese Patients</p></blockquote><h3>RelatesTos</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Target[x]</b></td></tr><tr><td style=\"display: none\">*</td><td>Justification</td><td><a href=\"ResearchStudy-Exemplar-ResearchStudy-Current-Amendment.html\">ResearchStudy: extension = ,,; identifier = Sponsor Protocol Identifier: ABC-Exemplar\u00a0(use:\u00a0usual,\u00a0); version = (a); status = active</a></td></tr></table><p><b>status</b>: Active</p><p><b>phase</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C15602}\">Phase III Trial</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-Exemplar-MedicinalProduct.html\">MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code: EX2015/03</a></td></tr></table><p><b>condition</b>: <span title=\"Codes:{http://snomed.info/sct 1137328006}\">Iatrogenic hypoglycaemia</span></p><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C70793}\">Clinical Study Sponsor</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-Sponsor-Organization.html\">Organization Exemplar Pharmaceuticals Co.</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C70793}\">Clinical Study Sponsor</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-Sponsor-Practitioner.html\">Practitioner Dr Exemplar Practitioner</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215669}\">Study Co-Sponsor</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-CoSponsor-Organization.html\">Organization Exemplar Pharmazeutika GmBH.</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215669}\">Study Co-Sponsor</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-CoSponsor-Practitioner.html\">Practitioner Dr Exemplar von Practitioner</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215670}\">Local Legal Sponsor</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-Local-Sponsor-Organization.html\">Organization Fictive Pharmaceuticals (Australia) Pty</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C215670}\">Local Legal Sponsor</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-Local-Sponsor-Practitioner.html\">Practitioner Bruce Exemplar</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C156625}\">Device Manufacturer</span></p><p><b>party</b>: <a href=\"Organization-Exemplar-Devices-Organization.html\">Organization Exemplar Devices Ltd</a></p></blockquote><blockquote><p><b>associatedParty</b></p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C51876}\">Sponsor Medical Expert</span></p><p><b>party</b>: <a href=\"Practitioner-Exemplar-Sponsor-Expert-Practitioner.html\">Practitioner Dr Exemplar Consultant</a></p></blockquote></div>"
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"value" : "ABC-Exemplar"
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"code" : "C218684"
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"text" : "EU CT Number"
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"value" : "EU-1234"
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"text" : "Other Regulatory or Clinical Trial Identifier"
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"value" : "ERA1234",
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"text" : "Amendment Identifier"
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"version" : "(a)",
"title" : "A Phase 3 Study of Inhaled Exoticillin compared to Intramuscular Exoticillin for Treatment of Bronchtis Japanese Patients with Iatrogenic Diabetes Mellitus",
"label" : [
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"condition" : [
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"party" : {
🔗 "reference" : "Practitioner/Exemplar-CoSponsor-Practitioner"
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"code" : "C215670",
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"party" : {
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},
"party" : {
🔗 "reference" : "Practitioner/Exemplar-Local-Sponsor-Practitioner"
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{
"role" : {
"coding" : [
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"code" : "C156625",
"display" : "Device Manufacturer"
}
]
},
"party" : {
🔗 "reference" : "Organization/Exemplar-Devices-Organization"
}
},
{
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C51876",
"display" : "Sponsor Medical Expert"
}
]
},
"party" : {
🔗 "reference" : "Practitioner/Exemplar-Sponsor-Expert-Practitioner"
}
}
]
}
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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