Clinical Study Protocol
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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

: Protocol Summary

Page standards status: Informative

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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 "Exemplar-Protocol-Summary"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study-profile>     ] )
  ] ; # 
  fhir:language [ fhir:v "en"] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div [ fhir:v "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ResearchStudy Exemplar-Protocol-Summary</b></p><a name=\"Exemplar-Protocol-Summary\"> </a><a name=\"hcExemplar-Protocol-Summary\"> </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 Profile</a></p></div><blockquote><p><b>M11_ProtocolSummary</b></p><blockquote><p><b>url</b></p>objectiveAndEstimandSummary</blockquote><p><b>value</b>: The primary objective of this study is to see if Inhaled Exoticillin achieves similar or better results compared to intramuscular Exoticillin when treating Bronchtis in Japanese Patients who also have Iatrogenic Diabetes Mellitus.  The seconday objective is to evaluate the cost differences in treatment.\nEvaluation will be by recording the average days to recovery, the total combined cost of medication and cost of hospital stay.</p><blockquote><p><b>url</b></p>interventionModel</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82639}\">Parallel Group</span></p><blockquote><p><b>url</b></p>populationType</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218503}\">With Disease</span></p><blockquote><p><b>url</b></p>controlType</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C218505}\">Different Dose or Regimen</span></p><blockquote><p><b>url</b></p>comparator</blockquote><p><b>value</b>: <a href=\"MedicinalProductDefinition-Exemplar-ComparatorProduct.html\">MedicinalProductDefinition: identifier = Sponsor's Investigational Product Code:  EX2010/12</a></p><blockquote><p><b>url</b></p>minimumAge</blockquote><p><b>value</b>: 18 Years<span style=\"background: LightGoldenRodYellow\"> (Details: NCI Thesaurus  codeC29848 = 'C29848')</span></p><blockquote><p><b>url</b></p>maximumAge</blockquote><p><b>value</b>: 55 Years<span style=\"background: LightGoldenRodYellow\"> (Details: NCI Thesaurus  codeC29848 = 'C29848')</span></p><blockquote><p><b>url</b></p>interventionAssignmentMethod</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C25196}\">Randomisation</span></p><blockquote><p><b>url</b></p>randomisationType</blockquote><p><b>value</b>: <span title=\"Codes:\">block randomisation</span></p><blockquote><p><b>url</b></p>otherInterventionAssignmentMethod</blockquote><p><b>value</b>: </p><blockquote><p><b>url</b></p>stratificationIndicator</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>siteDistribution</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C217005}\">Multicentre</span></p><blockquote><p><b>url</b></p>siteGeographicScope</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C217007}\">Multiple Countries </span></p><blockquote><p><b>url</b></p>masterProtocolIndicator</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C49487}\">No</span></p><blockquote><p><b>url</b></p>drug-DeviceCombinationProductIndicator</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>adaptiveTrialDesignIndicator</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C49487}\">No</span></p><blockquote><p><b>url</b></p>numberOfArms</blockquote><p><b>value</b>: 2</p><blockquote><p><b>url</b></p>trialBlindSchema</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C187674}\">Observer Blind</span></p><blockquote><p><b>url</b></p>blindedRoles</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C142710}\">Participant</span></p><blockquote><p><b>url</b></p>blindedRoles</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C17445}\">Care Provider </span></p><blockquote><p><b>url</b></p>targetOrMaximum</blockquote><p><b>value</b>: <span title=\"Codes:{https://HL7Vulcan.org/UDP/target T}\">Target</span></p><blockquote><p><b>url</b></p>numberOfParticipants</blockquote><p><b>value</b>: 200</p><blockquote><p><b>url</b></p>alternateDescriptionOfPlannedDurationOfTrialIntervention</blockquote><p><b>value</b>: Will depend on response to treatment</p><blockquote><p><b>url</b></p>totalPlannedDurationOfTrialParticipation</blockquote><p><b>value</b>: 3 Months<span style=\"background: LightGoldenRodYellow\"> (Details: NCI Thesaurus  codeC29846 = 'C29846')</span></p><blockquote><p><b>url</b></p>independentCommittees</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C142578}\">Independent Data Monitoring Committee</span></p><blockquote><p><b>url</b></p>independentCommittees</blockquote><p><b>value</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C17649}\">Other</span></p><blockquote><p><b>url</b></p>otherCommittees</blockquote><p><b>value</b>: Exemplar Monitoring Board</p><blockquote><p><b>url</b></p>trialSchema</blockquote><blockquote><p><b>url</b></p>schemaNotes</blockquote><p><b>value</b>: Hic textus tantummodo locum tenens est. Nullum verum sensum habet praeter spatium in pagina vel velo implere. Utile tamen est ad rem illustrandam. Huiusmodi ineptiae plerumque cum \\\"lorem ipsum\\\" incipiunt, sed ita translatae non sunt textus laetus.</p><blockquote><p><b>url</b></p>scheduleofActivities</blockquote><blockquote><p><b>url</b></p>populationDiagnosisOrCondition</blockquote><blockquote><p><b>url</b></p>unitsOfMinimumAge</blockquote><blockquote><p><b>url</b></p>unitsOfMaximumAge</blockquote><blockquote><p><b>url</b></p>totalPlannedDurationOfTrialIntervention</blockquote><blockquote><p><b>url</b></p>alternateDescriptionOfPlannedDurationOfTrialParticipation</blockquote><blockquote><p><b>url</b></p>additionalDescriptionofDuration</blockquote></blockquote><blockquote><p><b>M11 Research Study Extension</b></p><blockquote><p><b>url</b></p>originalProtocol</blockquote><blockquote><p><b>url</b></p>versionDate</blockquote></blockquote><p><b>identifier</b>: Sponsor Protocol Identifier/ABC-Exemplar (use: usual, )</p><p><b>status</b>: Active</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 32398004}\">Bronchitis (disorder)</span>, <span title=\"Codes:{http://snomed.info/sct 1137328006}\">Iatrogenic hypoglycaemia</span></p></div>"^^rdf:XMLLiteral ]
  ] ; # 
  fhir:extension ( [
    ( fhir:extension [
fhir:url [ fhir:v "objectiveAndEstimandSummary"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "The primary objective of this study is to see if Inhaled Exoticillin achieves similar or better results compared to intramuscular Exoticillin when treating Bronchtis in Japanese Patients who also have Iatrogenic Diabetes Mellitus.  The seconday objective is to evaluate the cost differences in treatment.\nEvaluation will be by recording the average days to recovery, the total combined cost of medication and cost of hospital stay."       ]     ] [
fhir:url [ fhir:v "interventionModel"^^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 "C82639" ] ;
fhir:display [ fhir:v "Parallel Group" ]         ] )       ]     ] [
fhir:url [ fhir:v "populationType"^^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 "C218503" ] ;
fhir:display [ fhir:v "With Disease" ]         ] )       ]     ] [
fhir:url [ fhir:v "controlType"^^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 "C218505" ] ;
fhir:display [ fhir:v "Different Dose or Regimen" ]         ] )       ]     ] [
fhir:url [ fhir:v "comparator"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicinalProductDefinition/Exemplar-ComparatorProduct" ]       ]     ] [
fhir:url [ fhir:v "minimumAge"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "18"^^xsd:decimal ] ;
fhir:unit [ fhir:v "Years" ] ;
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C29848" ]       ]     ] [
fhir:url [ fhir:v "maximumAge"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "55"^^xsd:decimal ] ;
fhir:unit [ fhir:v "Years" ] ;
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C29848" ]       ]     ] [
fhir:url [ fhir:v "interventionAssignmentMethod"^^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 "C25196" ] ;
fhir:display [ fhir:v "Randomisation" ]         ] )       ]     ] [
fhir:url [ fhir:v "randomisationType"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
fhir:text [ fhir:v "block randomisation" ]       ]     ] [
fhir:url [ fhir:v "otherInterventionAssignmentMethod"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v ""       ]     ] [
fhir:url [ fhir:v "stratificationIndicator"^^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 "C49488" ] ;
fhir:display [ fhir:v "Yes" ]         ] )       ]     ] [
fhir:url [ fhir:v "siteDistribution"^^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 "C217005" ] ;
fhir:display [ fhir:v "Multicentre" ]         ] )       ]     ] [
fhir:url [ fhir:v "siteGeographicScope"^^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 "C217007" ] ;
fhir:display [ fhir:v "Multiple Countries " ]         ] )       ]     ] [
fhir:url [ fhir:v "masterProtocolIndicator"^^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 "C49487" ] ;
fhir:display [ fhir:v "No" ]         ] )       ]     ] [
fhir:url [ fhir:v "drug-DeviceCombinationProductIndicator"^^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 "C49488" ] ;
fhir:display [ fhir:v "Yes" ]         ] )       ]     ] [
fhir:url [ fhir:v "adaptiveTrialDesignIndicator"^^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 "C49487" ] ;
fhir:display [ fhir:v "No" ]         ] )       ]     ] [
fhir:url [ fhir:v "numberOfArms"^^xsd:anyURI ] ;
fhir:value [
a fhir:integer ;
fhir:v 2       ]     ] [
fhir:url [ fhir:v "trialBlindSchema"^^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 "C187674" ] ;
fhir:display [ fhir:v "Observer Blind" ]         ] )       ]     ] [
fhir:url [ fhir:v "blindedRoles"^^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 "C142710" ] ;
fhir:display [ fhir:v "Participant" ]         ] )       ]     ] [
fhir:url [ fhir:v "blindedRoles"^^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 "C17445" ] ;
fhir:display [ fhir:v "Care Provider " ]         ] )       ]     ] [
fhir:url [ fhir:v "targetOrMaximum"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "https://HL7Vulcan.org/UDP/target"^^xsd:anyURI ] ;
fhir:code [ fhir:v "T" ] ;
fhir:display [ fhir:v "Target" ]         ] )       ]     ] [
fhir:url [ fhir:v "numberOfParticipants"^^xsd:anyURI ] ;
fhir:value [
a fhir:integer ;
fhir:v 200       ]     ] [
fhir:url [ fhir:v "alternateDescriptionOfPlannedDurationOfTrialIntervention"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Will depend on response to treatment"       ]     ] [
fhir:url [ fhir:v "totalPlannedDurationOfTrialParticipation"^^xsd:anyURI ] ;
fhir:value [
a fhir:Quantity ;
fhir:value [ fhir:v "3"^^xsd:decimal ] ;
fhir:unit [ fhir:v "Months" ] ;
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C29846" ]       ]     ] [
fhir:url [ fhir:v "independentCommittees"^^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 "C142578" ] ;
fhir:display [ fhir:v "Independent Data Monitoring Committee" ]         ] )       ]     ] [
fhir:url [ fhir:v "independentCommittees"^^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 "C17649" ] ;
fhir:display [ fhir:v "Other" ]         ] )       ]     ] [
fhir:url [ fhir:v "otherCommittees"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Exemplar Monitoring Board"       ]     ] [
fhir:url [ fhir:v "trialSchema"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "schemaNotes"^^xsd:anyURI ] ;
fhir:value [
a fhir:string ;
fhir:v "Hic textus tantummodo locum tenens est. Nullum verum sensum habet praeter spatium in pagina vel velo implere. Utile tamen est ad rem illustrandam. Huiusmodi ineptiae plerumque cum \\\"lorem ipsum\\\" incipiunt, sed ita translatae non sunt textus laetus."       ]     ] [
fhir:url [ fhir:v "scheduleofActivities"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "populationDiagnosisOrCondition"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "unitsOfMinimumAge"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "unitsOfMaximumAge"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "totalPlannedDurationOfTrialIntervention"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "alternateDescriptionOfPlannedDurationOfTrialParticipation"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "additionalDescriptionofDuration"^^xsd:anyURI ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-protocol-summary"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "originalProtocol"^^xsd:anyURI ]     ] [
fhir:url [ fhir:v "versionDate"^^xsd:anyURI ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/clinical-study-protocol/StructureDefinition/m11-research-study"^^xsd:anyURI ]
  ] ) ; # 
  fhir:identifier ( [
fhir:use [ fhir:v "usual" ] ;
fhir:type [
      ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C132351" ] ;
fhir:display [ fhir:v "Sponsor Protocol Identifier" ]       ] )     ] ;
fhir:system [ fhir:v "https://exemplarSponsor.com/sponsor-identifier"^^xsd:anyURI ] ;
fhir:value [ fhir:v "ABC-Exemplar" ]
  ] ) ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:focus ( [
fhir:reference [
fhir:reference [ fhir:v "MedicinalProductDefinition/Exemplar-MedicinalProduct" ]     ]
  ] ) ; # 
  fhir:condition ( [
    ( fhir:coding [
a sct:32398004 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "32398004" ] ;
fhir:display [ fhir:v "Bronchitis (disorder)" ]     ] )
  ] [
    ( 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" ]     ] )
  ] ) . #