Clinical Study Schedule of Activites
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This page is part of the Clinical Study Schedule of Activities (v1.0.0-ballot: STU1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

: H2Q-MC-LZZT Research Study - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@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:Resource.id [ fhir:value "H2Q-MC-LZZT-ResearchStudy"]; # 
  fhir:Resource.meta [
     fhir:Meta.profile [
       fhir:value "http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa";
       fhir:index 0;
       fhir:link <http://hl7.org/fhir/uv/vulcan-schedule/StructureDefinition/ResearchStudySoa>     ]
  ]; # 
  fhir:DomainResource.text [
     fhir:Narrative.status [ fhir:value "generated" ];
     fhir:Narrative.div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"H2Q-MC-LZZT-ResearchStudy\"> </a></p><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\">Resource ResearchStudy &quot;H2Q-MC-LZZT-ResearchStudy&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ResearchStudySoa.html\">ResearchStudySoa</a></p></div><p><b>identifier</b>: id: H2Q-MC-LZZT (use: USUAL), id: NCTA12313212 (use: OFFICIAL), id: 60809</p><p><b>title</b>: Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>protocol</b>: <a href=\"PlanDefinition-H2Q-MC-LZZT-ProtocolDesign.html\">PlanDefinition/H2Q-MC-LZZT-ProtocolDesign</a></p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: Treatment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-prim-purp-type.html\">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-phase.html\">ResearchStudyPhase</a>#phase-3)</span></p><p><b>category</b>: Interventional Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C98388)</span>, Randomized Clinical Trial <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C15417)</span>, Double Blind Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C15228)</span>, Placebo Control <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C49648)</span>, Parallel Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C82639)</span></p><p><b>focus</b>: Xanomeline <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C152926)</span>, Transdermal Patch Dosage Form <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C149996)</span>, PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> ()</span></p><p><b>condition</b>: Alzheimer's Disease (Disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#26929004)</span></p><p><b>contact</b>: Bob James, Ph.D.: ph: 555-555-5555(WORK)</p><h3>RelatedArtifacts</h3><table class=\"grid\"><tr><td>-</td><td><b>Type</b></td><td><b>Label</b></td><td><b>Display</b></td><td><b>Citation</b></td><td><b>Url</b></td></tr><tr><td>*</td><td>documentation</td><td>Arch Neurol.1997;54(4):465-473</td><td>Arch Neurol.1997;54(4):465-473</td><td>Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022</td><td> </td></tr><tr><td>*</td><td>documentation</td><td>Protocol H2Q-MC-LZZT(c)</td><td> </td><td> </td><td><a href=\"https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf\">https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf</a></td></tr></table><p><b>keyword</b>: Selective M1 muscarinic agonists <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D018721)</span>, Alzheimer Disease <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D000544)</span>, Selective M1 muscarinic agonists <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-MeSH.html\">Medical Subject Headings</a>#D018721)</span></p><p><b>description</b>: ## Xanomeline (LY246708)\n### Protocol H2Q-MC-LZZT(c) \nSafety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease</p><p><b>sponsor</b>: <a href=\"Organization-EliLillyAndCompany.html\">Organization/EliLillyAndCompany</a></p><p><b>principalInvestigator</b>: <a href=\"Practitioner-SamGetWell.html\">Practitioner/SamGetWell</a> &quot; HOME&quot;</p><p><b>reasonStopped</b>: Accrual Goal Met <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-reason-stopped.html\">ResearchStudyReasonStopped</a>#accrual-goal-met)</span></p><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo</p><p><b>type</b>: C49648 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C49648)</span></p><p><b>description</b>: Placebo arm</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Low-dose xanomeline arm</p><p><b>type</b>: C174266 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C174266)</span></p><p><b>description</b>: Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: High-dose xanomeline arm</p><p><b>type</b>: C174266 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (ncimeta.nci.nih.gov#C174266)</span></p><p><b>description</b>: High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)</p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg]).</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To document the safety profile of the xanomeline TTS.</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: To assess the treatment response as a function of Apo E genotype.</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote></div>"
  ]; # 
  fhir:ResearchStudy.identifier [
     fhir:index 0;
     fhir:Identifier.use [ fhir:value "usual" ];
     fhir:Identifier.value [ fhir:value "H2Q-MC-LZZT" ]
  ], [
     fhir:index 1;
     fhir:Identifier.use [ fhir:value "official" ];
     fhir:Identifier.system [ fhir:value "https://clinicaltrials.gov/show/" ];
     fhir:Identifier.value [ fhir:value "NCTA12313212" ]
  ], [
     fhir:index 2;
     fhir:Identifier.value [ fhir:value "60809" ]
  ]; # 
  fhir:ResearchStudy.title [ fhir:value "Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"]; # 
  fhir:ResearchStudy.protocol [
     fhir:index 0;
     fhir:Reference.reference [ fhir:value "PlanDefinition/H2Q-MC-LZZT-ProtocolDesign" ]
  ]; # 
  fhir:ResearchStudy.status [ fhir:value "completed"]; # 
  fhir:ResearchStudy.primaryPurposeType [
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type" ];
       fhir:Coding.code [ fhir:value "treatment" ]     ]
  ]; # 
  fhir:ResearchStudy.phase [
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/research-study-phase" ];
       fhir:Coding.code [ fhir:value "phase-3" ]     ]
  ]; # 
  fhir:ResearchStudy.category [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
       fhir:Coding.code [ fhir:value "C98388" ];
       fhir:Coding.display [ fhir:value "Interventional Study" ]     ]
  ], [
     fhir:index 1;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
       fhir:Coding.code [ fhir:value "C15417" ];
       fhir:Coding.display [ fhir:value "Randomized Clinical Trial" ]     ]
  ], [
     fhir:index 2;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
       fhir:Coding.code [ fhir:value "C15228" ];
       fhir:Coding.display [ fhir:value "Double Blind Study" ]     ]
  ], [
     fhir:index 3;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
       fhir:Coding.code [ fhir:value "C49648" ];
       fhir:Coding.display [ fhir:value "Placebo Control" ]     ]
  ], [
     fhir:index 4;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
       fhir:Coding.code [ fhir:value "C82639" ];
       fhir:Coding.display [ fhir:value "Parallel Study" ]     ]
  ]; # 
  fhir:ResearchStudy.focus [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
       fhir:Coding.code [ fhir:value "C152926" ];
       fhir:Coding.display [ fhir:value "Xanomeline" ]     ]
  ], [
     fhir:index 1;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
       fhir:Coding.code [ fhir:value "C149996" ];
       fhir:Coding.display [ fhir:value "Transdermal Patch Dosage Form" ]     ]
  ], [
     fhir:index 2;
     fhir:CodeableConcept.text [ fhir:value "PUBMED#9109749 Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease" ]
  ]; # 
  fhir:ResearchStudy.condition [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       a sct:26929004;
       fhir:Coding.system [ fhir:value "http://snomed.info/sct" ];
       fhir:Coding.code [ fhir:value "26929004" ];
       fhir:Coding.display [ fhir:value "Alzheimer's Disease (Disorder)" ]     ]
  ]; # 
  fhir:ResearchStudy.contact [
     fhir:index 0;
     fhir:ContactDetail.name [ fhir:value "Bob James, Ph.D." ];
     fhir:ContactDetail.telecom [
       fhir:index 0;
       fhir:ContactPoint.system [ fhir:value "phone" ];
       fhir:ContactPoint.value [ fhir:value "555-555-5555" ];
       fhir:ContactPoint.use [ fhir:value "work" ]     ]
  ]; # 
  fhir:ResearchStudy.relatedArtifact [
     fhir:index 0;
     fhir:RelatedArtifact.type [ fhir:value "documentation" ];
     fhir:RelatedArtifact.label [ fhir:value "Arch Neurol.1997;54(4):465-473" ];
     fhir:RelatedArtifact.display [ fhir:value "Arch Neurol.1997;54(4):465-473" ];
     fhir:RelatedArtifact.citation [ fhir:value "Bodick NC, Offen WW, Levey AI, et al. Effects of xanomeline, a selective muscarinic receptor agonist, on cognitive function and behavioral symptoms in Alzheimer disease. Arch Neurol. 1997;54(4):465-473. doi:10.1001/archneur.1997.00550160091022" ]
  ], [
     fhir:index 1;
     fhir:RelatedArtifact.type [ fhir:value "documentation" ];
     fhir:RelatedArtifact.label [ fhir:value "Protocol H2Q-MC-LZZT(c)" ];
     fhir:RelatedArtifact.url [ fhir:value "https://clinicaltrials.gov/show/NCTA12313212/Lzzt_protocol_redacted.pdf" ]
  ]; # 
  fhir:ResearchStudy.keyword [
     fhir:index 0;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "https://www.nlm.nih.gov/mesh" ];
       fhir:Coding.code [ fhir:value "D018721" ]     ];
     fhir:CodeableConcept.text [ fhir:value "Selective M1 muscarinic agonists" ]
  ], [
     fhir:index 1;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "https://www.nlm.nih.gov/mesh" ];
       fhir:Coding.code [ fhir:value "D000544" ]     ];
     fhir:CodeableConcept.text [ fhir:value "Alzheimer Disease" ]
  ], [
     fhir:index 2;
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "https://www.nlm.nih.gov/mesh" ];
       fhir:Coding.code [ fhir:value "D018721" ]     ];
     fhir:CodeableConcept.text [ fhir:value "Selective M1 muscarinic agonists" ]
  ]; # 
  fhir:ResearchStudy.description [ fhir:value "## Xanomeline (LY246708)\n### Protocol H2Q-MC-LZZT(c) \nSafety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease"]; # 
  fhir:ResearchStudy.sponsor [
     fhir:Reference.reference [ fhir:value "Organization/EliLillyAndCompany" ]
  ]; # 
  fhir:ResearchStudy.principalInvestigator [
     fhir:Reference.reference [ fhir:value "Practitioner/SamGetWell" ]
  ]; # 
  fhir:ResearchStudy.reasonStopped [
     fhir:CodeableConcept.coding [
       fhir:index 0;
       fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/research-study-reason-stopped" ];
       fhir:Coding.code [ fhir:value "accrual-goal-met" ]     ]
  ]; # 
  fhir:ResearchStudy.arm [
     fhir:index 0;
     fhir:ResearchStudy.arm.name [ fhir:value "Placebo" ];
     fhir:ResearchStudy.arm.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
         fhir:Coding.code [ fhir:value "C49648" ]       ]     ];
     fhir:ResearchStudy.arm.description [ fhir:value "Placebo arm" ]
  ], [
     fhir:index 1;
     fhir:ResearchStudy.arm.name [ fhir:value "Low-dose xanomeline arm" ];
     fhir:ResearchStudy.arm.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
         fhir:Coding.code [ fhir:value "C174266" ]       ]     ];
     fhir:ResearchStudy.arm.description [ fhir:value "Low-dose xanomeline arm (50 cm2 TTS Formulation E, 54 mg xanomeline)" ]
  ], [
     fhir:index 2;
     fhir:ResearchStudy.arm.name [ fhir:value "High-dose xanomeline arm" ];
     fhir:ResearchStudy.arm.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://ncimeta.nci.nih.gov" ];
         fhir:Coding.code [ fhir:value "C174266" ]       ]     ];
     fhir:ResearchStudy.arm.description [ fhir:value "High-dose xanomeline arm (75 cm2 TTS Formulation E, 81 mg xanomeline)" ]
  ]; # 
  fhir:ResearchStudy.objective [
     fhir:index 0;
     fhir:ResearchStudy.objective.name [ fhir:value "To determine if there is a statistically significant relationship (overall Type 1 error rate, α=.05) between the change in both ADAS-Cog and CIBIC scores, and drug dose (0, 50 cm2 [54 mg], and 75 cm2 [81 mg])." ];
     fhir:ResearchStudy.objective.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/research-study-objective-type" ];
         fhir:Coding.code [ fhir:value "primary" ]       ]     ]
  ], [
     fhir:index 1;
     fhir:ResearchStudy.objective.name [ fhir:value "To document the safety profile of the xanomeline TTS." ];
     fhir:ResearchStudy.objective.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/research-study-objective-type" ];
         fhir:Coding.code [ fhir:value "primary" ]       ]     ]
  ], [
     fhir:index 2;
     fhir:ResearchStudy.objective.name [ fhir:value "To assess the dose-dependent improvement in behavior. Improved scores on the Revised Neuropsychiatric Inventory (NPI-X) will indicate improvement in these areas." ];
     fhir:ResearchStudy.objective.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/research-study-objective-type" ];
         fhir:Coding.code [ fhir:value "secondary" ]       ]     ]
  ], [
     fhir:index 3;
     fhir:ResearchStudy.objective.name [ fhir:value "To assess the dose-dependent improvements in activities of daily living. Improved scores on the Disability Assessment for Dementia (DAD) will indicate improvement in these areas." ];
     fhir:ResearchStudy.objective.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/research-study-objective-type" ];
         fhir:Coding.code [ fhir:value "secondary" ]       ]     ]
  ], [
     fhir:index 4;
     fhir:ResearchStudy.objective.name [ fhir:value "To assess the dose-dependent improvements in an extended assessment of cognition that integrates attention/concentration tasks. The Alzheimer’s Disease Assessment Scale-14 item Cognitive Subscale, hereafter referred to as ADAS-Cog (14), will be used for this assessment." ];
     fhir:ResearchStudy.objective.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/research-study-objective-type" ];
         fhir:Coding.code [ fhir:value "secondary" ]       ]     ]
  ], [
     fhir:index 5;
     fhir:ResearchStudy.objective.name [ fhir:value "To assess the treatment response as a function of Apo E genotype." ];
     fhir:ResearchStudy.objective.type [
       fhir:CodeableConcept.coding [
         fhir:index 0;
         fhir:Coding.system [ fhir:value "http://terminology.hl7.org/CodeSystem/research-study-objective-type" ];
         fhir:Coding.code [ fhir:value "secondary" ]       ]     ]
  ]. # 

# - ontology header ------------------------------------------------------------

 a owl:Ontology;
  owl:imports fhir:fhir.ttl.