# baseURI: https://w3id.org/phuse/study # imports: http://spinrdf.org/spl # imports: http://www.w3.org/2004/02/skos/core # imports: https://w3id.org/phuse/code# # prefix: study @prefix arg: . @prefix code: . @prefix owl: . @prefix rdf: . @prefix rdfs: . @prefix sdtmterm: . @prefix sh: . @prefix skos: . @prefix smf: . @prefix sp: . @prefix spin: . @prefix spl: . @prefix study: . @prefix time: . @prefix xsd: . arg:activityDate a rdf:Property ; rdfs:subPropertyOf sp:arg ; . arg:birthdate a rdf:Property ; rdfs:subPropertyOf sp:arg ; . arg:datestring a rdf:Property ; rdfs:subPropertyOf sp:arg ; . arg:datestring1 a rdf:Property ; rdfs:subPropertyOf sp:arg ; . arg:datestring2 a rdf:Property ; rdfs:subPropertyOf sp:arg ; . arg:refDate a rdf:Property ; rdfs:subPropertyOf sp:arg ; . arg:refdate a rdf:Property ; rdfs:subPropertyOf sp:arg ; . owl:hasValue owl:oneOf ( ) ; . time:Duration a sh:NodeShape ; . time:Instant a sh:NodeShape ; rdfs:subClassOf [ a owl:Restriction ; owl:hasValue code:CodeSystem_ISO8601 ; owl:onProperty code:hasCodeSystem ; ] ; sh:property [ a sh:PropertyShape ; sh:path time:inXSDDate ; sh:datatype xsd:date ; sh:maxCount 1 ; sh:minCount 1 ; sh:name "in XSDDate" ; ] ; . time:Interval a sh:NodeShape ; sh:property [ a sh:PropertyShape ; sh:path time:hasBeginning ; sh:class study:BeginInstant ; sh:maxCount 1 ; sh:minCount 1 ; sh:name "has beginning" ; sh:nodeKind sh:IRI ; ] ; sh:property [ a sh:PropertyShape ; sh:path time:hasEnd ; sh:class study:EndInstant ; sh:minCount 1 ; sh:name "has end" ; sh:nodeKind sh:IRI ; ] ; sh:sparql [ sh:message "End Date {?enddate} is before Start Date {?beginddate) by {?dur} day(s). " ; sh:prefixes ; sh:select """SELECT $this ?enddate ?begindate ?dur WHERE { $this a time:Interval . $this time:hasBeginning ?begin . ?begin time:inXSDDate ?begindate . $this time:hasEnd ?end . ?end time:inXSDDate ?enddate . BIND (smf:duration(\"d\", ?begindate, ?enddate) AS ?dur) FILTER (?dur < 0) }""" ; ] ; . time:hasBeginning rdfs:subPropertyOf study:hasDate ; . time:inXSDDateTime rdfs:subPropertyOf study:dateTimeInXSDString ; . code:ActivityStatus_CO a study:ActivityStatus ; . code:ActivityStatus_IC a study:ActivityStatus ; . code:ActivityStatus_ND a study:ActivityStatus ; . code:ActivityStatus_ST a study:ActivityStatus ; . code:AgeDataCollection rdfs:subClassOf study:Observation ; . code:AnatomicLocation owl:equivalentClass [ a owl:Restriction ; owl:allValuesFrom code:BodyPosition ; owl:onProperty code:outcome ; ] ; . code:Arm a study:AnatomicLocation ; . code:BloodPressure owl:equivalentClass [ a owl:Restriction ; owl:allValuesFrom study:BloodPressureOutcome ; owl:onProperty code:outcome ; ] ; . code:BodyPosition_STANDING a study:BodyPosition ; . code:BodyPosition_SUPINE a study:BodyPosition ; . code:DemographicDataCollection rdfs:subClassOf study:Observation ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom code:GenericOutcome ; owl:onProperty code:outcome ; ] ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty study:hasActivity ; owl:someValuesFrom code:AgeDataCollection ; ] ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty study:hasActivity ; owl:someValuesFrom code:EthnicityDataCollection ; ] ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty study:hasActivity ; owl:someValuesFrom code:RaceDataCollection ; ] ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty study:hasActivity ; owl:someValuesFrom code:SexDataCollection ; ] ; . code:DiastolicBloodPressure rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:BloodPressureOutcome ; owl:onProperty code:outcome ; ] ; . code:EthnicityDataCollection rdfs:subClassOf study:Observation ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:EthnicOutcome ; owl:onProperty code:outcome ; ] ; . code:Ethnicity_HISPANIC_OR_LATINO a study:EthnicOutcome ; . code:Ethnicity_NOT_HISPANIC_OR_LATINO a study:EthnicOutcome ; . code:Ethnicity_NOT_REPORTED a study:EthnicOutcome ; . code:Ethnicity_UNKNOWN a study:EthnicOutcome ; . code:GenericOutcome rdfs:subClassOf study:CategoricalOutcome ; . code:Height rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:HeightOutcome ; owl:onProperty code:outcome ; ] ; . code:InformedConsentOutcome_1 a study:InformedConsentOutcome ; . code:InformedConsentOutcome_2 a study:InformedConsentOutcome ; . code:InformedConsentOutcome_3 a study:InformedConsentOutcome ; . code:Oral_Cavity a study:AnatomicLocation ; . code:Pulse rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:PulseOutcome ; owl:onProperty code:outcome ; ] ; . code:RaceDataCollection rdfs:subClassOf study:Observation ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:RaceOutcome ; owl:onProperty code:outcome ; ] ; . code:Race_AMERICAN_INDIAN_OR_ALASKA_NATIVE a study:RaceOutcome ; . code:Race_ASIAN a study:RaceOutcome ; . code:Race_BLACK_OR_AFRICAN_AMERICAN a study:RaceOutcome ; . code:Race_NATIVE_HAWAIIAN_OR_OTHER_PACIFIC_ISLANDER a study:RaceOutcome ; . code:Race_WHITE a study:RaceOutcome ; . code:RuleOutcome_FALSE a study:RuleOutcome ; . code:RuleOutcome_NA a study:RuleOutcome ; . code:RuleOutcome_TRUE a study:RuleOutcome ; . code:SexDataCollection rdfs:subClassOf study:Observation ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:SexOutcome ; owl:onProperty code:outcome ; ] ; . code:Sex_F a study:SexOutcome ; . code:Sex_M a study:SexOutcome ; . code:Sex_U a study:SexOutcome ; . code:Sex_UN a study:SexOutcome ; . code:SystolicBloodPressure rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:BloodPressureOutcome ; owl:onProperty code:outcome ; ] ; . code:Temperature rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:TemperatureOutcome ; owl:onProperty code:outcome ; ] ; . code:Weight rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:WeightOutcome ; owl:onProperty code:outcome ; ] ; . code:hasAge rdfs:range study:Age ; . code:hasCodeSystem code:hasCodeSystem code:CodeSystem_CDISCTerminology ; . code:hasNullFlavor rdfs:range code:NullFlavor ; skos:altLabel "" ; skos:prefLabel "has null flavor" ; . code:outcome a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:domain study:StudyActivity ; rdfs:range study:ActivityOutcome ; skos:altLabel "" ; skos:prefLabel "has outcome" ; . skos:prefLabel "F" ; . skos:prefLabel "U" ; . skos:prefLabel "M" ; . skos:prefLabel "UNDIFFERENTIATED" ; . sdtmterm:NoYesResponse_N a study:EligibilityDeterminationOutcome ; . sdtmterm:NoYesResponse_NA a study:EligibilityDeterminationOutcome ; . sdtmterm:NoYesResponse_Y a study:EligibilityDeterminationOutcome ; . a owl:Ontology ; spin:imports ; owl:imports ; owl:imports ; owl:imports code: ; owl:versionInfo "Created with TopBraid Composer" ; sh:declare [ a sh:PrefixDeclaration ; sh:namespace "http://www.w3.org/2006/time#"^^xsd:anyURI ; sh:prefix "time" ; ] ; . study:ActiveDrugProduct a owl:Class ; rdfs:subClassOf study:DrugProduct ; skos:altLabel "" ; skos:prefLabel "Active product" ; . study:Activity a owl:Class ; rdfs:subClassOf study:StudyComponent ; . study:ActivityBegin a owl:Class ; rdfs:subClassOf study:BeginInstant ; skos:prefLabel "Activity begin" ; . study:ActivityDate a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:BeginOrOccurInstant ; skos:definition "" ; skos:prefLabel "Activity date" ; . study:ActivityEnd a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:EndInstant ; skos:definition "" ; skos:prefLabel "Activity end" ; . study:ActivityInterval a owl:Class ; rdfs:comment "" ; rdfs:subClassOf time:Interval ; skos:definition "" ; skos:prefLabel "Activity interval" ; . study:ActivityOutcome a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Outcome ; skos:definition "An Entity that is the outcome of a Study Activity. For an Observation, this is the result of the observation. " ; skos:prefLabel "Activity outcome" ; . study:ActivityStatus a owl:Class ; rdfs:subClassOf study:Entity ; skos:definition "The Status or state of a StudyActivity. For example, Completed, Started, Not Done, Incomplete." ; skos:prefLabel "Activity status" ; . study:AdministrativeActivity a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:StudyActivity ; skos:definition "A StudyActivity that is performed primarily to facilitate administrative execution of a study. These are activities that are not routinely performed during ordinary patient care outside of a study setting. " ; skos:prefLabel "Administrative activity" ; . study:AdministrativeActivityOutcome a owl:Class ; rdfs:subClassOf study:ActivityOutcome ; skos:altLabel "" ; skos:prefLabel "Administrative activity outcome" ; . study:AdverseEvent a owl:Class ; a sh:NodeShape ; spin:rule [ a sp:Construct ; sp:templates ( [ sp:object [ sp:varName "dur" ; ] ; sp:predicate study:duration ; sp:subject spin:_this ; ] ) ; sp:where ( [ sp:object [ sp:varName "start" ; ] ; sp:predicate study:startDay ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "end" ; ] ; sp:predicate study:endDay ; sp:subject spin:_this ; ] [ a sp:Bind ; sp:expression [ a sp:add ; sp:arg1 [ a sp:sub ; sp:arg1 [ sp:varName "end" ; ] ; sp:arg2 [ sp:varName "start" ; ] ; ] ; sp:arg2 1 ; ] ; sp:variable [ sp:varName "dur" ; ] ; ] ) ; rdfs:comment "calculates duration in days when start day and end day are known." ; ] ; rdfs:comment "" ; rdfs:subClassOf study:MedicalCondition ; skos:definition "An adverse Medical Condition that emerges or worsens following a Medical Intervention, including the use of a drug. Note: there is no presumption of causality." ; skos:prefLabel "Adverse event" ; sh:property [ a sh:PropertyShape ; sh:path code:hasCode ; sh:class ; sh:maxCount 1 ; sh:minCount 1 ; sh:name "has code" ; sh:nodeKind sh:IRI ; ] ; sh:property [ a sh:PropertyShape ; sh:path code:outcome ; sh:class code:AdverseEventOutcome ; sh:maxCount 1 ; sh:name "outcome" ; sh:nodeKind sh:IRI ; ] ; sh:property [ a sh:PropertyShape ; sh:path study:causality ; sh:class code:Causality ; sh:maxCount 1 ; sh:minCount 1 ; sh:name "causality" ; sh:nodeKind sh:IRI ; ] ; sh:property [ a sh:PropertyShape ; sh:path study:hasInterval ; sh:class study:AdverseEventInterval ; sh:maxCount 1 ; sh:minCount 1 ; sh:name "has interval" ; sh:nodeKind sh:IRI ; ] ; sh:property [ a sh:PropertyShape ; sh:path study:reportedTerm ; sh:datatype xsd:string ; sh:maxCount 1 ; sh:minCount 1 ; sh:name "reported term" ; ] ; sh:property [ a sh:PropertyShape ; sh:path study:severity ; sh:class code:Severity ; sh:maxCount 1 ; sh:minCount 1 ; sh:name "severity" ; sh:nodeKind sh:IRI ; ] ; . study:AdverseEventBegin a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:BeginInstant ; skos:prefLabel "Adverse event begin" ; . study:AdverseEventEnd a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:EndInstant ; skos:prefLabel "Adverse event end" ; . study:AdverseEventInterval a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:MedicalConditionInterval ; skos:prefLabel "Adverse event interval" ; sh:property [ a sh:PropertyShape ; sh:path time:hasBeginning ; sh:class study:AdverseEventBegin ; sh:maxCount 1 ; sh:minCount 1 ; sh:name "has beginning" ; sh:nodeKind sh:IRI ; ] ; sh:property [ a sh:PropertyShape ; sh:path time:hasEnd ; sh:class study:AdverseEventEnd ; sh:maxCount 1 ; sh:name "has end" ; sh:nodeKind sh:IRI ; ] ; . study:AdverseEventOutcome a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:MedicalConditionOutcome ; skos:prefLabel "Adverse event outcome" ; . study:Age a owl:Class ; rdfs:subClassOf time:Duration ; rdfs:subClassOf study:NumericOutcome ; skos:prefLabel "Age" ; . study:Allocation a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:AdministrativeActivity ; skos:definition "" ; skos:prefLabel "Allocation" ; . study:AllocationOutcome a owl:Class ; rdfs:subClassOf study:AdministrativeActivityOutcome ; skos:altLabel "" ; skos:prefLabel "Allocation outcome" ; . study:Analysis a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:StudyActivity ; rdfs:subClassOf [ a owl:Restriction ; owl:hasValue code:Method_DERIVED ; owl:onProperty code:hasMethod ; ] ; skos:definition "An examination, sometimes via a mathematical manipulation, of one or more observations to obtain a result." ; skos:note "The important point here is that data already exist as input to an analysis. No additional data collection on the HumanStudySubject is needed. " ; skos:prefLabel "Analysis" ; . study:AnalysisOutcome a owl:Class ; rdfs:subClassOf study:ActivityOutcome ; skos:prefLabel "Analysis outcome" ; . study:AnatomicLocation a owl:Class ; rdfs:subClassOf study:Entity ; skos:definition "The location on the body where an activity/process occurs or an entity is located. " ; skos:prefLabel "Anatomic location" ; . study:Animal a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:BiologicEntity ; skos:definition "A non-human living organism that has membranous cell walls, requires oxygen and organic foods, and is capable of voluntary movement, as distinguished from a plant or mineral. [BRIDG 5.0]" ; skos:note "maps to BRIDG Animal Class" ; skos:prefLabel "Animal" ; . study:AnimalStudySubject a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:AnimalSubject ; skos:prefLabel "Animal study subject" ; . study:AnimalSubject a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Animal ; rdfs:subClassOf study:Subject ; skos:definition "A Subject that is also an Animal (see definition of both). An Animal Subject need not participate in a Study. " ; skos:prefLabel "Animal subject" ; . study:AnnotatedCaseReportForm a owl:Class ; rdfs:subClassOf study:BlankCaseReportForm ; skos:altLabel "" ; skos:prefLabel "Annotated Case Report Form" ; . study:Arm a owl:Class ; rdfs:subClassOf study:StudyDesignActivity ; skos:altLabel "ARMCD" ; skos:definition "A path though the study which describes what activities the study subject or experimental unit will be involved in as they pass through the study (BRIDG 5.0)" ; skos:prefLabel "ARM" ; . study:Assessment a owl:Class ; rdfs:comment "when formalized in a protocol, this is often called an Adjudication process. " ; rdfs:subClassOf study:Analysis ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:Assessor ; owl:onProperty study:hasPerformer ; ] ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:MedicalCondition ; owl:onProperty code:outcome ; ] ; skos:definition "An examination or Analysis of one or more clinical observations to identify and/or characterize a Medical Condition." ; skos:prefLabel "Assessment" ; . study:AssessmentRule a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Rule ; skos:definition "" ; skos:prefLabel "Assessment rule" ; . study:Assessor a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Party ; owl:equivalentClass [ a owl:Restriction ; owl:onProperty study:performsActivity ; owl:someValuesFrom study:Assessment ; ] ; skos:definition "A Party that performs an Assessment (See study:Assessment) " ; skos:prefLabel "Assessor" ; . study:BeginInstant a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:BeginOrOccurInstant ; skos:definition "" ; skos:prefLabel "Begin" ; . study:BeginOrOccurInstant a owl:Class ; a sh:NodeShape ; rdfs:comment "" ; rdfs:subClassOf time:Instant ; skos:definition "The date and time when something occurs or begins" ; skos:prefLabel "Date" ; . study:BiologicEntity a owl:Class ; a sh:NodeShape ; spin:rule [ a sp:Construct ; sp:templates ( [ sp:object [ sp:varName "age" ; ] ; sp:predicate code:hasAge ; sp:subject spin:_this ; ] ) ; sp:where ( [ sp:object study:BiologicEntity ; sp:predicate rdf:type ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "ageactivity" ; ] ; sp:predicate study:participatesIn ; sp:subject spin:_this ; ] [ sp:object code:AgeDataCollection ; sp:predicate rdf:type ; sp:subject [ sp:varName "ageactivity" ; ] ; ] [ sp:object [ sp:varName "age" ; ] ; sp:predicate code:outcome ; sp:subject [ sp:varName "ageactivity" ; ] ; ] [ sp:object study:Age ; sp:predicate rdf:type ; sp:subject [ sp:varName "age" ; ] ; ] ) ; rdfs:comment "age assignment" ; ] ; spin:rule [ a sp:Construct ; sp:templates ( [ sp:object [ sp:varName "sex" ; ] ; sp:predicate study:sex ; sp:subject spin:_this ; ] ) ; sp:where ( [ sp:object study:BiologicEntity ; sp:predicate rdf:type ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "sexactivity" ; ] ; sp:predicate study:participatesIn ; sp:subject spin:_this ; ] [ sp:object code:SexDataCollection ; sp:predicate rdf:type ; sp:subject [ sp:varName "sexactivity" ; ] ; ] [ sp:object [ sp:varName "sex" ; ] ; sp:predicate code:outcome ; sp:subject [ sp:varName "sexactivity" ; ] ; ] [ sp:object study:SexOutcome ; sp:predicate rdf:type ; sp:subject [ sp:varName "sex" ; ] ; ] ) ; rdfs:comment "sex assignment" ; ] ; rdfs:subClassOf study:Party ; skos:definition "Any individual living (or previously living) being. [BRIDG 5.0]" ; skos:note "maps to BRIDG BiologicEntity class. " ; skos:prefLabel "Biologic entity" ; . study:Birthdate a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:BeginInstant ; skos:definition "" ; skos:prefLabel "Birthdate" ; . study:BlankCaseReportForm a owl:Class ; rdfs:subClassOf study:CaseReportForm ; skos:altLabel "" ; skos:prefLabel "Blank case report form" ; . study:BloodPressureOutcome a owl:Class ; rdfs:subClassOf study:NumericOutcome ; rdfs:subClassOf study:VitalSignOutcome ; rdfs:subClassOf [ a owl:Restriction ; owl:hasValue code:Unit_mmHG ; owl:onProperty code:hasUnit ; ] ; skos:altLabel "" ; skos:prefLabel "Blood pressure outcome" ; . study:BodyPosition a owl:Class ; rdfs:subClassOf study:InterventionOutcome ; skos:prefLabel "Body position" ; . study:CRFLocation a owl:Class ; rdfs:subClassOf study:Entity ; skos:definition "A portion of the case report form; usually a location or page number in the CRF where a particular piece of information is located." ; skos:prefLabel "CRFComponent" ; . study:CaseReportForm a owl:Class ; rdfs:subClassOf study:Document ; skos:altLabel "" ; skos:prefLabel "Case report form" ; . study:CategoricalOutcome a owl:Class ; rdfs:subClassOf study:ObservationOutcome ; . study:Category a owl:Class ; rdfs:subClassOf study:Entity ; skos:altLabel "" ; skos:prefLabel "Category" ; . study:CompositeRule a owl:Class ; rdfs:subClassOf study:Rule ; skos:prefLabel "Composite rule" ; . study:ControlArm a owl:Class ; rdfs:subClassOf study:TrueArm ; skos:prefLabel "Control arm" ; . study:Country a owl:Class ; rdfs:subClassOf study:Entity ; skos:prefLabel "Country" ; . study:CumulativeDrugAdministration a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:TherapeuticIntervention ; skos:definition "The act of administering/taking a Drug Product over time; there may be breaks or the dose may change over time" ; skos:prefLabel "Product administration" ; . study:CumulativeDrugAdministrationBegin a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:ActivityBegin ; skos:definition "" ; skos:prefLabel "Product administration begin" ; . study:CumulativeDrugAdministrationEnd a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:ActivityEnd ; skos:definition "" ; skos:prefLabel "Product administration end" ; . study:CumulativeDrugAdministrationInterval a owl:Class ; spin:rule [ a sp:Construct ; sp:templates ( [ sp:object [ sp:varName "d1" ; ] ; sp:predicate time:hasBeginning ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "d2" ; ] ; sp:predicate time:hasEnd ; sp:subject spin:_this ; ] ) ; sp:where ( [ a sp:SubQuery ; sp:query [ a sp:Select ; sp:groupBy ( [ sp:varName "s" ; ] ) ; sp:resultVariables ( [ sp:varName "s" ; ] [ sp:expression [ a sp:Min ; sp:expression [ sp:varName "startdate" ; ] ; ] ; sp:varName "rxs" ; ] [ sp:expression [ a sp:Max ; sp:expression [ sp:varName "enddate" ; ] ; ] ; sp:varName "rxe" ; ] ) ; sp:where ( [ sp:object study:HumanStudySubject ; sp:predicate rdf:type ; sp:subject [ sp:varName "s" ; ] ; ] [ sp:object [ sp:varName "fda" ; ] ; sp:predicate study:participatesIn ; sp:subject [ sp:varName "s" ; ] ; ] [ sp:object study:FixedDoseDrugAdministration ; sp:predicate rdf:type ; sp:subject [ sp:varName "fda" ; ] ; ] [ sp:object [ sp:varName "fdi" ; ] ; sp:predicate study:hasInterval ; sp:subject [ sp:varName "fda" ; ] ; ] [ sp:object [ sp:varName "start" ; ] ; sp:predicate time:hasBeginning ; sp:subject [ sp:varName "fdi" ; ] ; ] [ sp:object [ sp:varName "end" ; ] ; sp:predicate time:hasEnd ; sp:subject [ sp:varName "fdi" ; ] ; ] [ sp:object [ sp:varName "sstart" ; ] ; sp:predicate study:dateTimeInXSDString ; sp:subject [ sp:varName "start" ; ] ; ] [ sp:object [ sp:varName "send" ; ] ; sp:predicate study:dateTimeInXSDString ; sp:subject [ sp:varName "end" ; ] ; ] [ a sp:Bind ; sp:expression [ a xsd:string ; sp:arg1 [ sp:varName "sstart" ; ] ; ] ; sp:variable [ sp:varName "startdate" ; ] ; ] [ a sp:Bind ; sp:expression [ a xsd:string ; sp:arg1 [ sp:varName "send" ; ] ; ] ; sp:variable [ sp:varName "enddate" ; ] ; ] ) ; ] ; ] [ sp:object [ sp:varName "padmin" ; ] ; sp:predicate study:participatesIn ; sp:subject [ sp:varName "s" ; ] ; ] [ sp:object study:CumulativeDrugAdministration ; sp:predicate rdf:type ; sp:subject [ sp:varName "padmin" ; ] ; ] [ sp:object spin:_this ; sp:predicate study:hasInterval ; sp:subject [ sp:varName "padmin" ; ] ; ] [ sp:object study:CumulativeDrugAdministrationInterval ; sp:predicate rdf:type ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "rxs" ; ] ; sp:predicate study:dateTimeInXSDString ; sp:subject [ sp:varName "d1" ; ] ; ] [ sp:object [ sp:varName "rxe" ; ] ; sp:predicate study:dateTimeInXSDString ; sp:subject [ sp:varName "d2" ; ] ; ] ) ; rdfs:comment "Calculate CumulativeProduct Administration Start and End dates from individual exposure data" ; ] ; rdfs:comment "" ; rdfs:subClassOf study:ActivityInterval ; skos:definition "" ; skos:prefLabel "Product administration interval" ; . study:DataCollectionDate a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:ActivityDate ; skos:prefLabel "Data collection date" ; . study:DataCutoff a owl:Class ; rdfs:subClassOf study:AdministrativeActivity ; skos:prefLabel "Data cutoff" ; . study:DataCutoffDate a owl:Class ; rdfs:subClassOf study:ActivityDate ; skos:prefLabel "Data cutoff date" ; . study:DeathFlag a owl:Class ; rdfs:subClassOf study:Flag ; skos:prefLabel "Death flag" ; code:hasMethod code:Method_DERIVED ; . study:Deathdate a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:EndInstant ; skos:definition "" ; skos:prefLabel "Deathdate" ; . study:DemogDataCollectionDate a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:DataCollectionDate ; skos:definition "" ; skos:prefLabel "Demog data collect begin" ; . study:Derivation a owl:Class ; rdfs:subClassOf study:Analysis ; skos:altLabel "" ; skos:definition "An Analysis that examines one or more observations for a HumanStudySubject and obtains a result that is also specific for that HumanStudySubject. " ; skos:note "The key is that the result (e.g. derived variable) belongs to the HumanStudySubject. In contrast the result of an efficacy or safety analysis is specific for the study population, not the individual subject. " ; skos:prefLabel "Derivation" ; . study:Document a owl:Class ; rdfs:subClassOf study:Entity ; skos:altLabel "" ; skos:definition "An organized representation of information in publishable, human-readable form (that persists over time). [BRIDG 5.0]" ; skos:note "maps to BRIDG Document class" ; skos:prefLabel "Document" ; . study:DrugAdministrationComplete a study:DrugAdministrationOutcome ; skos:prefLabel "Drug administration complete" ; . study:DrugAdministrationOutcome a owl:Class ; rdfs:subClassOf study:ActivityOutcome ; skos:prefLabel "Drug administration outcome" ; . study:DrugProduct a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Product ; skos:definition "A Product that is \"intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.\" (USA Food, Drug, and Cosmetic Act) " ; skos:prefLabel "Drug product" ; . study:DrugSubstance a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Substance ; skos:definition "A Substance that is found in a DrugProduct" ; skos:prefLabel "Drug substance" ; . study:EligibilityCriterion a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Rule ; skos:definition "" ; skos:prefLabel "Eligibility criteria" ; . study:EligibilityDetermination a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:AdministrativeActivity ; rdfs:subClassOf study:StartRule ; skos:prefLabel "Eligibility determination" ; . study:EligibilityDeterminationOutcome a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:AdministrativeActivityOutcome ; skos:prefLabel "Eligibility determination outcome" ; . study:EligibleSubject a owl:Class ; rdfs:comment "The eligible subject meets all eligibility criteria and is a candidate to proceed to the next activity, often allocation to a treatment strategy in a randomized trial." ; rdfs:subClassOf study:StudySubject ; skos:definition "A StudySubject who has succesfully completed the Screening Activity" ; skos:prefLabel "Eligible subject" ; . study:EndInstant a owl:Class ; rdfs:comment "" ; rdfs:subClassOf time:Instant ; skos:definition "" ; skos:prefLabel "End" ; . study:EnrolledPopulation a owl:Class ; rdfs:subClassOf study:Population ; skos:definition "A Group of Subjects consisting of all Subjects who are Enrolled: It includes those who pass Screening, and those who fail screening but accidentally or intentionally participate in any Study Activity after Screening. " ; skos:prefLabel "Enrolled population" ; . study:EnrolledSubject a owl:Class ; rdfs:comment "an Enrolled Subject includes Eligible subjects but may include ineligible subjects who are accidentally or intentionally allocated to a treatment arm; therefore is not a subClass of Eligible Subject necessarily. In a randomized trial, it is equivalent to a Randomized Subject. " ; rdfs:subClassOf study:StudySubject ; skos:definition "A Study Subject that has been allocated to a treatment arm in a Study" ; skos:prefLabel "Enrolled subject" ; . study:Entity a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:StudyComponent ; skos:definition "" ; skos:prefLabel "Entity" ; . study:EntityInterval a owl:Class ; a sh:NodeShape ; rdfs:subClassOf time:Interval ; skos:prefLabel "Entity interval" ; . study:EntityOutcome a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Outcome ; skos:prefLabel "Entity outcome" ; . study:Epoch a owl:Class ; rdfs:subClassOf study:StudyDesignActivity ; skos:prefLabel "Epoch" ; . study:EpochDuration a owl:Class ; rdfs:subClassOf time:Duration ; skos:prefLabel "Epoch duration" ; . study:EpochInterval a owl:Class ; rdfs:subClassOf study:ActivityInterval ; skos:prefLabel "Epoch interval" ; . study:EthnicOutcome a owl:Class ; rdfs:subClassOf study:CategoricalOutcome ; skos:prefLabel "Ethnic outcome" ; . study:Evaluator a owl:Class ; rdfs:subClassOf study:Party ; skos:definition "" ; skos:note "Evaluator is used in CDISC. Need to find CDISC definition. " ; skos:prefLabel "QEVAL" ; . study:Event a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Entity ; skos:definition "An occurrence; something that happens. An event persists in time. " ; skos:prefLabel "Event" ; . study:FalseArm a owl:Class ; rdfs:subClassOf study:Arm ; skos:definition "A StudyActivity that is tracked during the study as an Arm but is not really an Arm. e.g. ARM=Screen Failure " ; skos:prefLabel "False arm" ; . study:FixedDoseDrugAdministration a owl:Class ; rdfs:subClassOf study:TherapeuticIntervention ; skos:definition "A Therapeutic Intervention during which a fixed dose of a drug product is administered over a documented interval of time. " ; skos:prefLabel "Fixed Dose Drug administration" ; . study:FixedDoseInterval a owl:Class ; rdfs:subClassOf study:ActivityInterval ; skos:definition "Provides the start and end dates for a fixed dosing interval, i.e. during which the dose administered did not change" ; skos:prefLabel "Fixed dose interval" ; . study:FixedDoseIntervalBegin a owl:Class ; rdfs:subClassOf study:ActivityBegin ; skos:prefLabel "Fixed dose interval begin" ; . study:FixedDoseIntervalEnd a owl:Class ; rdfs:subClassOf study:ActivityEnd ; skos:prefLabel "Fixed dose interval end" ; . study:Flag a owl:Class ; rdfs:subClassOf study:Derivation ; skos:altLabel "" ; skos:definition "A Derivation where the result (outcome) is binary e.g. Y/N. " ; skos:prefLabel "Flag" ; . study:Group a owl:Class ; rdfs:subClassOf study:Party ; skos:prefLabel "Group" ; . study:HeightOutcome a owl:Class ; rdfs:subClassOf study:NumericOutcome ; rdfs:subClassOf study:VitalSignOutcome ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom code:HeightUnit ; owl:onProperty code:hasUnit ; ] ; skos:prefLabel "Height length outcome" ; . study:HumanStudySubject a owl:Class ; rdfs:comment "The subject participates in at least one screening activity but may not necessarily pass screening or continue in the study" ; rdfs:subClassOf study:HumanSubject ; skos:definition "A Human Subject who participates in any Study Activity" ; skos:prefLabel "Human study subject" ; . study:HumanSubject a owl:Class ; rdfs:subClassOf study:Person ; rdfs:subClassOf study:Subject ; skos:definition "A Person of interest for participation in a Study. 45 CFR 46 defines a human subject as “a living individual about whom an investigator...conducting research obtains: Data through intervention or interaction with the individual, or Identifiable private information.”" ; skos:note "typically a Human Subject is the target of some recruitment activity or voluntarily inquires about participating in a Study. a human subject need not paraticipate in a study, but allows the collection of data or identifiable private information for the purpose of research. " ; skos:prefLabel "Human subject" ; . study:Identifier a owl:Class ; rdfs:subClassOf study:Entity ; skos:prefLabel "Identifier" ; . study:Indication a owl:Class ; rdfs:subClassOf study:Entity ; skos:definition "The Reason that a TherapeuticIntervention is performed on a Subject. " ; skos:example "Indication: the PREVENTION of STROKE in patients with CHRONIC ATRIAL FIBRILLATION. or the TREATMENT of HODGKIN'S DISEASE; or the TREATMENT of SEIZURES in patients with PRIMARY GENERALIZED EPILEPSY. " ; skos:note "An Indication has three components: the IndicationType (e.g. the intended effect of the TherapeuticIntervention, such as treat, cure, prevent), the IndicatioinCondition (e.g. the MedicalCondition on which the TherapeuticIntervention is expected to affect), and an optional UnderlyingCondition (e.g. an important coexisting MedicalCondition) See example. " ; skos:prefLabel "Indication" ; . study:IndicationCondition a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:MedicalCondition ; skos:definition "A MedicalCondition that is the target of a TherapeuticIntervention in a Study" ; skos:prefLabel "Indication" ; . study:InformedConsent a owl:Class ; rdfs:subClassOf study:AdministrativeActivity ; owl:equivalentClass [ a owl:Restriction ; owl:allValuesFrom study:InformedConsentOutcome ; owl:onProperty code:outcome ; ] ; skos:altLabel "" ; skos:prefLabel "Informed consent" ; . study:InformedConsentBegin a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:ActivityBegin ; skos:definition "" ; skos:prefLabel "Informed consent begin" ; . study:InformedConsentEnd a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:ActivityEnd ; skos:definition "" ; skos:prefLabel "Informed consent end" ; . study:InformedConsentInterval a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:ActivityInterval ; skos:definition "" ; skos:prefLabel "Informed consent interval" ; . study:InformedConsentOutcome a owl:Class ; rdfs:subClassOf study:AdministrativeActivityOutcome ; skos:altLabel "" ; skos:prefLabel "Informed consent outcome" ; . study:Intervention a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:StudyActivity ; skos:definition "A study activity that involves an interruption to the study subject's normal daily routine for the purpose of observing the subject's physical, psychological, or physiological state, and/or mitigating the effects of a medical condition. " ; skos:prefLabel "Intervention" ; . study:InterventionDate a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:ActivityDate ; skos:definition "" ; skos:prefLabel "Intervention date" ; . study:InterventionOutcome a owl:Class ; rdfs:subClassOf study:ActivityOutcome ; skos:altLabel "" ; skos:prefLabel "Intervention outcome" ; . study:InvestigationalArm a owl:Class ; rdfs:subClassOf study:TrueArm ; skos:prefLabel "Investigational arm" ; . study:InvestigationalProduct a owl:Class ; rdfs:subClassOf study:ActiveDrugProduct ; skos:altLabel "" ; skos:prefLabel "Investigational product" ; skos:related ; . study:InvestigationalSubstance a owl:Class ; rdfs:subClassOf study:DrugSubstance ; skos:altLabel "" ; skos:definition "A DrugSubstance that is the primary focus of a Study. " ; skos:note "Often an InvestigationalSubstance is not approved for the Indication being studied. " ; skos:prefLabel "Investigational substance" ; . study:Investigator a owl:Class ; rdfs:comment "maps to BRIDG StudyInvestigator class. " ; rdfs:subClassOf study:ResearchStaff ; skos:definition """A researcher in a study who oversees multiple aspects of the study, such as concept development, protocol writing, protocol submission for IRB approval, participant recruitment, informed consent, data collection, analysis, interpretation and presentation. [BRIDG 5.0]""" ; skos:prefLabel "Investigator" ; . study:InvestigatorIdentifier a owl:Class ; rdfs:subClassOf study:Identifier ; skos:prefLabel "Investigator identifier" ; . study:LaboratoryObservation a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Observation ; skos:definition "A Clinical Observation that requires the collection of a biospecimen for submission to a laboratory for further inspection" ; skos:prefLabel "Laboratory observation" ; . study:Lifespan a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:EntityInterval ; skos:definition "" ; skos:prefLabel "Lifespan" ; . study:MaximumSubjectAge a owl:Class ; rdfs:subClassOf study:ScreeningCriterion ; rdfs:subClassOf [ a owl:Restriction ; owl:hasValue study:StartRuleDefault_1 ; owl:onProperty study:hasStartRule ; ] ; skos:prefLabel "Maximum age subject" ; . study:MedicalCondition a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Event ; skos:definition """An event that is a disease, injury, disorder, or transient physiologic state that interferes or may interfere with well-being. A medical condition persists in time. """ ; skos:note "Medical conditions are the target of medical interventions. Medical conditions explain the presence of clinical observations. Most clinicians will agree that pregnancy is a medical condition because it benefits from medical intervention (e.g. prenatal care) to minimize complications to the mother and unborn child" ; skos:prefLabel "Medical condition" ; . study:MedicalConditionInterval a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:EntityInterval ; skos:prefLabel "Medical event interval" ; . study:MedicalConditionOutcome a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:EntityOutcome ; skos:prefLabel "Medical condition outcome" ; . study:MinimumSubjectAge a owl:Class ; rdfs:subClassOf study:ScreeningCriterion ; skos:prefLabel "Minimum age subject" ; . study:NumericOutcome a owl:Class ; rdfs:subClassOf study:ObservationOutcome ; . study:Objective a owl:Class ; rdfs:subClassOf study:Entity ; skos:prefLabel "Objective" ; . study:Observation a owl:Class ; rdfs:subClassOf study:Intervention ; skos:definition " An Intervention whose intent is to measure the physical, physiological, or psychological state of a Person." ; skos:note """An observation is ideally observed by a qualified individual, following a standard process, but without implying a cause. Many clinical observations simply reflect a normal physiological state. e.g. BP 120/80 mmHg. The classification of an Observation as a subclass of Intervention deviates from BRIDG and other models in that it recognizes that an observation requires intervening in the Person's normal routine and that intervention method may impact the observation result. Synonyms: clinical observation, biomedical concept. """ ; skos:prefLabel "Observation" ; . study:ObservationEndDate a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:ActivityEnd ; skos:definition "" ; skos:prefLabel "Observation end date" ; . study:ObservationOutcome a owl:Class ; rdfs:subClassOf study:InterventionOutcome ; skos:altLabel "" ; skos:prefLabel "Observation outcome" ; . study:Organization a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Group ; skos:definition "" ; skos:prefLabel "Organization" ; . study:Outcome a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Entity ; skos:prefLabel "Outcome" ; . study:OutcomeMeasure a owl:Class ; rdfs:subClassOf study:Observation ; skos:definition "An observation that is used to measure a particular outcome of interest as described in a StudyObjective. " ; skos:prefLabel "Outcome measure" ; . study:Party a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Entity ; skos:definition "A Person or an Organization." ; skos:prefLabel "Party" ; . study:PerformedActivity a owl:Class ; rdfs:subClassOf study:StudyActivity ; owl:equivalentClass [ a owl:Restriction ; owl:hasValue code:ActivityStatus_CO ; owl:onProperty study:activityStatus ; ] ; skos:definition "An Activity that was performed on a specific time interval or instant. It has activity status as COMPLETE" ; skos:prefLabel "Performed activity" ; . study:PerformedActivityDate a owl:Class ; rdfs:subClassOf study:ActivityDate ; skos:prefLabel "Performed activity date" ; . study:Person a owl:Class ; spin:rule [ a sp:Construct ; sp:templates ( [ sp:object [ sp:varName "race" ; ] ; sp:predicate study:race ; sp:subject spin:_this ; ] ) ; sp:where ( [ sp:object study:Person ; sp:predicate rdf:type ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "raceactivity" ; ] ; sp:predicate study:participatesIn ; sp:subject spin:_this ; ] [ sp:object code:RaceDataCollection ; sp:predicate rdf:type ; sp:subject [ sp:varName "raceactivity" ; ] ; ] [ sp:object [ sp:varName "race" ; ] ; sp:predicate code:outcome ; sp:subject [ sp:varName "raceactivity" ; ] ; ] [ sp:object study:RaceOutcome ; sp:predicate rdf:type ; sp:subject [ sp:varName "race" ; ] ; ] ) ; rdfs:comment "race assignment" ; ] ; rdfs:comment "" ; rdfs:subClassOf study:BiologicEntity ; skos:definition "" ; skos:prefLabel "Person" ; . study:PlaceboDrugProduct a owl:Class ; rdfs:subClassOf study:DrugProduct ; skos:altLabel "" ; skos:prefLabel "Placebo product" ; . study:PlannedActivity a owl:Class ; rdfs:comment "a planned activity can also be a completed activity if it has a protocol specified start rule. " ; rdfs:subClassOf study:StudyActivity ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:HumanStudySubject ; owl:onProperty study:hasParticipant ; ] ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty study:hasStartRule ; owl:someValuesFrom study:StartRule ; ] ; skos:definition "An Activity that is or was intended to occur. It is associated with a performer and/or a participant and is associated with a start rule that is described in the protocol. " ; skos:prefLabel "Planned activity" ; . study:Population a owl:Class ; rdfs:subClassOf study:Group ; skos:definition "A Group of Subjects associated with a Study" ; skos:prefLabel "Study population" ; . study:PopulationFlag a owl:Class ; rdfs:subClassOf study:Flag ; skos:altLabel "" ; skos:prefLabel "Population flag" ; . study:PreparatoryIntervention a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Intervention ; skos:definition "An Intervention whose purpose is to prepare a Person for a subsequent Intervention. " ; skos:example "Assume a Body Position before a Blood Pressure Measurement. " ; skos:prefLabel "Preparatory intervention" ; . study:PrerequisiteActivity a owl:Class ; rdfs:subClassOf study:StudyActivity ; skos:definition "A StudyActivity whose Date functions as a time point reference for other activities. " ; skos:note "For example: An activity to assume a supine body position can be a prerequisite activity for a BP measurement 5 minutes later. An activity outcome could be a medical condition, e.g. the ActivityOutcome can be a migraine headache, which triggers another activity: drug administration. " ; skos:prefLabel "Anchor / Time Point Reference" ; . study:PrimaryObjective a owl:Class ; rdfs:subClassOf study:Objective ; skos:prefLabel "Primary objective" ; . study:PrimaryOutcomeMeasure a owl:Class ; rdfs:subClassOf study:OutcomeMeasure ; skos:definition "An observation that is used to measure a particular outcome of interest as described in a Study Primary Objective" ; skos:prefLabel "Primary outcome measure" ; . study:PrincipalInvestigator a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Investigator ; skos:definition "The principal investigator (PI) at a site who is responsible for all activities related to a specific organizational network's research at that site. [BRIDG 5.0]" ; skos:note "maps to the BRIDG AdministrativeMemberPI Class" ; skos:prefLabel "Principal investigator" ; . study:Product a owl:Class ; rdfs:subClassOf study:Entity ; skos:altLabel "" ; skos:prefLabel "Product" ; . study:ProtocolDocument a owl:Class ; rdfs:subClassOf study:Document ; skos:altLabel "" ; skos:prefLabel "Protocol document" ; . study:ProtocolSpecifiedActivity a owl:Class ; rdfs:subClassOf study:StudyActivity ; rdfs:subClassOf [ a owl:Restriction ; owl:onProperty study:hasStartRule ; owl:someValuesFrom study:StartRule ; ] ; skos:definition "A StudyActivity that is specified in the Protocol to occur in the Study. It is associated with a start rule but not necessarily with a subject. A protocol specified activity is instantiated for each Subject in the study. The instance of a protocol specified activity is a Planned Activity and is linked to a subject." ; skos:prefLabel "Protocol specified activity" ; . study:PulseOutcome a owl:Class ; rdfs:subClassOf study:NumericOutcome ; rdfs:subClassOf study:VitalSignOutcome ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom code:PulseUnit ; owl:onProperty code:hasUnit ; ] ; skos:prefLabel "Pulse or Heart Rate outcome" ; . study:RaceOutcome a owl:Class ; rdfs:subClassOf study:CategoricalOutcome ; skos:prefLabel "Race outcome" ; . study:Randomization a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Allocation ; owl:equivalentClass [ a owl:Restriction ; owl:allValuesFrom study:RandomizationOutcome ; owl:onProperty code:outcome ; ] ; skos:definition "" ; skos:prefLabel "Randomization" ; . study:RandomizationOutcome a owl:Class ; rdfs:subClassOf study:AllocationOutcome ; skos:altLabel "" ; skos:prefLabel "Randomization outcome" ; . study:ReferenceBegin a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:BeginInstant ; skos:definition "" ; skos:prefLabel "Reference start date" ; . study:ReferenceEnd a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:EndInstant ; skos:definition "" ; skos:prefLabel "Reference end date" ; . study:ReferenceInterval a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:EntityInterval ; skos:definition "" ; skos:prefLabel "Reference interval" ; . study:ResearchStaff a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Person ; owl:equivalentClass ; skos:definition "" ; skos:prefLabel "Research staff" ; . study:Rule a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Analysis ; owl:equivalentClass [ a owl:Restriction ; owl:allValuesFrom study:RuleOutcome ; owl:onProperty code:outcome ; ] ; skos:definition "An Analysis that examines whether one or more observations or derivations meet certain pre-defined target(s). If the target is met, then the rule outcome is set to true, otherwise it is set to false if the target is not met " ; skos:example "1. Age >= 18 or 2. Sex = Female" ; skos:prefLabel "Rule" ; . study:RuleOutcome a owl:Class ; rdfs:subClassOf study:AnalysisOutcome ; skos:prefLabel "Rule outcome" ; . study:ScheduledActivity a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:StudyActivity ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:BeginOrOccurInstant ; owl:onProperty study:hasScheduledDate ; ] ; skos:definition "An activity that is or was scheduled to occur on a HumanStudySubject at a specific date/time" ; skos:prefLabel "Scheduled activity" ; . study:ScheduledActivityDate a owl:Class ; rdfs:subClassOf study:ActivityDate ; skos:prefLabel "Scheduled activity date" ; . study:ScreeningCriterion a owl:Class ; rdfs:subClassOf study:EligibilityCriterion ; skos:definition "An Eligibility Criterion that is applied before screening to determine is Screening Activities may begin (e.g. Age, Sex)" ; skos:prefLabel "Screening criterion" ; . study:SecondaryObjective a owl:Class ; rdfs:subClassOf study:Objective ; skos:prefLabel "Secondary objective" ; . study:SecondaryOutcomeMeasure a owl:Class ; rdfs:subClassOf study:OutcomeMeasure ; skos:definition "An observation that is used to measure a particular outcome of interest as described in a Study Secondary Objective" ; skos:prefLabel "Secondary outcome measure" ; . study:Set a owl:Class ; rdfs:subClassOf study:Group ; skos:definition "A group of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design (SEND IG 3.0)" ; skos:prefLabel "Set" ; . study:SexOutcome a owl:Class ; rdfs:subClassOf study:CategoricalOutcome ; skos:prefLabel "Sex outcome" ; . study:Site a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Organization ; skos:definition "" ; skos:prefLabel "Site" ; . study:SiteIdentifier a owl:Class ; rdfs:subClassOf study:Identifier ; skos:prefLabel "Site identifier" ; code:hasMethod code:Method_ASSIGNED ; . study:Species a owl:Class ; rdfs:subClassOf study:Group ; skos:prefLabel "Species" ; . study:Sponsor a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Organization ; skos:definition "" ; skos:prefLabel "Sponsor" ; . study:StartRule a owl:Class ; rdfs:subClassOf study:Rule ; skos:altLabel "" ; skos:prefLabel "Start rule" ; . study:StartRuleComposite a owl:Class ; rdfs:subClassOf study:StartRule ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:StartRuleSimple ; owl:onProperty study:hasSubRule ; ] ; rdfs:subClassOf [ a owl:Restriction ; owl:minCardinality "2"^^xsd:nonNegativeInteger ; owl:onProperty study:hasSubRule ; ] ; skos:definition "A collection of start rules, each of which has two or more sub-rules. Each sub-rule must evaluate to TRUE for the composite start rule to be TRUE. " ; skos:prefLabel "Start rule composite" ; . study:StartRuleDefault a owl:Class ; rdfs:subClassOf study:StartRuleSimple ; skos:definition "Activity may start at any time" ; skos:prefLabel "Start rule default" ; . study:StartRuleDefault_1 a study:StartRuleDefault ; skos:definition "Activity may start at any time at the discretion of the Investigator" ; skos:prefLabel "Start rule default 1" ; code:outcome code:RuleOutcome_TRUE ; study:activityStatus code:ActivityStatus_CO ; . study:StartRuleInformedConsentGranted rdfs:subClassOf study:StartRulePrereqActivityOutcome ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:InformedConsent ; owl:onProperty study:hasPrerequisite ; ] ; rdfs:subClassOf [ a owl:Restriction ; owl:hasValue code:InformedConsentOutcome_1 ; owl:onProperty study:hasPrereqExpectedOutcome ; ] ; skos:definition "Target activity starts after informed consent has been granted. " ; skos:prefLabel "RULE INFORMED CONSENT GRANTED" ; study:hasPrereqExpectedOutcome code:InformedConsentOutcome_1 ; study:hasPrereqExpectedStatus code:ActivityStatus_CO ; . study:StartRuleInformedConsentStart a owl:Class ; rdfs:subClassOf study:StartRulePrereqActivityStart ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:InformedConsent ; owl:onProperty study:hasPrerequisite ; ] ; rdfs:subClassOf [ a owl:Restriction ; owl:hasValue code:ActivityStatus_ST ; owl:onProperty study:hasPrereqExpectedStatus ; ] ; skos:prefLabel "Start rule informed consent started" ; study:hasPrereqExpectedStatus code:ActivityStatus_ST ; . study:StartRulePrereqActivityComplete a owl:Class ; rdfs:subClassOf study:StartRulePrerequisiteActivity ; rdfs:subClassOf [ a owl:Restriction ; owl:hasValue code:ActivityStatus_CO ; owl:onProperty study:hasPrereqExpectedStatus ; ] ; skos:definition "A collection of Start Rules that trigger, i.e. evaluate to TRUE, when the Prerequisite Activity is completed and optionally has a certain expected outcome. " ; skos:prefLabel "Start rule prereq activity complete" ; . study:StartRulePrereqActivityOutcome a owl:Class ; rdfs:subClassOf study:StartRulePrereqActivityComplete ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:ActivityOutcome ; owl:onProperty study:hasPrereqExpectedOutcome ; ] ; skos:definition "A collection of Start Rules that trigger, i.e. evaluate to TRUE, when the Prerequisite Activity is completed and has a certain expected outcome. " ; skos:prefLabel "Start rule prereq activity outcome" ; . study:StartRulePrereqActivityStart a owl:Class ; rdfs:subClassOf study:StartRulePrerequisiteActivity ; rdfs:subClassOf [ a owl:Restriction ; owl:hasValue code:ActivityStatus_ST ; owl:onProperty study:hasPrereqExpectedStatus ; ] ; skos:definition "A collection of Start Rules that resolve to TRUE when the prespecified Prerequisite activity starts. e.g. Screening Visit starts when Informed Consent starts. " ; skos:prefLabel "Start rule prereq activity start" ; . study:StartRulePrerequisiteActivity a owl:Class ; rdfs:subClassOf study:StartRuleSimple ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:PrerequisiteActivity ; owl:onProperty study:hasPrerequisite ; ] ; skos:definition "A start rule that relies on the conduct of a Prerequisite Activity" ; . study:StartRuleSimple a owl:Class ; rdfs:subClassOf study:StartRule ; skos:definition "A start rule that is based on the evaluation of a single true/false condition, e.g. an outcome of an activity being present. Simple start rules can be combined together using an AND expression to create composite rules, such as eligibility criteria. " ; . study:StopRule a owl:Class ; rdfs:subClassOf study:Rule ; skos:prefLabel "Stop rule" ; . study:Strain a owl:Class ; rdfs:subClassOf study:Group ; skos:prefLabel "Strain" ; . study:Study a owl:Class ; spin:rule [ a sp:Construct ; sp:templates ( [ sp:object [ sp:varName "narms" ; ] ; sp:predicate study:narms ; sp:subject spin:_this ; ] ) ; sp:where ( [ sp:object study:Study ; sp:predicate rdf:type ; sp:subject spin:_this ; ] [ a sp:SubQuery ; sp:query [ a sp:Select ; sp:resultVariables ( [ sp:expression [ a sp:Count ; sp:expression [ sp:varName "arm" ; ] ; ] ; sp:varName "narms" ; ] ) ; sp:where ( [ sp:object study:Study ; sp:predicate rdf:type ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "arm" ; ] ; sp:predicate study:hasActivity ; sp:subject spin:_this ; ] [ sp:object study:TrueArm ; sp:predicate rdf:type ; sp:subject [ sp:varName "arm" ; ] ; ] ) ; ] ; ] ) ; rdfs:comment "Derives the number of arms in the study" ; ] ; rdfs:comment "" ; rdfs:subClassOf study:Activity ; skos:broader ; skos:definition "A research project conducted on HumanStudySubjects whose objectives are to test or confirm hypotheses concerning the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product,cosmetic, care plan, or subject characteristic." ; skos:note "The BRIDG concept Study is broader in that it includes nonclinical studies whereas this ontology is limited to human studies" ; skos:prefLabel "Study" ; . study:StudyActivity a owl:Class ; spin:rule [ a sp:Construct ; sp:templates ( [ sp:object [ sp:varName "pldate" ; ] ; sp:predicate study:hasScheduledDate ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "scheddatexsd" ; ] ; sp:predicate time:inXSDDateTime ; sp:subject [ sp:varName "pldate" ; ] ; ] [ sp:object study:ScheduledActivity ; sp:predicate rdf:type ; sp:subject spin:_this ; ] ) ; sp:where ( [ sp:object [ sp:varName "strtrule" ; ] ; sp:predicate study:hasStartRule ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "strtrulecode" ; ] ; sp:predicate study:hasIdentifier ; sp:subject [ sp:varName "strtrule" ; ] ; ] [ sp:object [ sp:varName "anchoroutcometerm" ; ] ; sp:predicate study:hasPrereqExpectedOutcome ; sp:subject [ sp:varName "strtrulecode" ; ] ; ] [ sp:object [ sp:varName "strtdelay" ; ] ; sp:predicate study:hasDelay ; sp:subject [ sp:varName "strtrulecode" ; ] ; ] [ sp:object [ sp:varName "anchor" ; ] ; sp:predicate study:hasPrerequisite ; sp:subject spin:_this ; ] [ sp:object [ sp:varName "anchoroutcome" ; ] ; sp:predicate code:outcome ; sp:subject [ sp:varName "anchor" ; ] ; ] [ a sp:Filter ; sp:expression [ a sp:eq ; sp:arg1 [ sp:varName "anchoroutcometerm" ; ] ; sp:arg2 [ sp:varName "anchoroutcome" ; ] ; ] ; ] [ sp:object [ sp:varName "anchordate" ; ] ; sp:predicate study:hasDate ; sp:subject [ sp:varName "anchor" ; ] ; ] [ sp:object [ sp:varName "anchrxsddate" ; ] ; sp:predicate time:inXSDDateTime ; sp:subject [ sp:varName "anchordate" ; ] ; ] [ a sp:Bind ; sp:expression [ a sp:add ; sp:arg1 [ sp:varName "anchrxsddate" ; ] ; sp:arg2 [ sp:varName "strtdelay" ; ] ; ] ; sp:variable [ sp:varName "scheddatexsd" ; ] ; ] ) ; rdfs:comment "derive scheduled start date based on a start rule **in progress**" ; ] ; spin:rule [ a sp:Construct ; sp:templates ( [ sp:object [ sp:varName "status" ; ] ; sp:predicate study:activityStatus ; sp:subject spin:_this ; ] ) ; sp:where ( [ sp:object [ sp:varName "outcome" ; ] ; sp:predicate code:outcome ; sp:subject spin:_this ; ] [ a sp:Bind ; sp:expression [ a sp:if ; sp:arg1 [ a sp:bound ; sp:arg1 [ sp:varName "outcome" ; ] ; ] ; sp:arg2 code:ActivityStatus_CO ; sp:arg3 "" ; ] ; sp:variable [ sp:varName "status" ; ] ; ] ) ; rdfs:comment "Marks an activity as COMPLETE if there is a recorded activity outcome" ; ] ; rdfs:comment "maps to BRIDG 5.0 Activity: Any action that can, in the context of a study, experiment or a post-marketing investigation, be defined, planned, scheduled or performed. " ; rdfs:subClassOf study:Activity ; skos:definition "Any activity associated with the planning, conduct, analysis, and interpretation of a Study" ; skos:prefLabel "Activity" ; . study:StudyBegin a owl:Class ; rdfs:subClassOf study:ActivityBegin ; skos:prefLabel "Study begin" ; . study:StudyComponent a owl:Class ; rdfs:comment "" ; skos:definition "" ; skos:prefLabel "Study component" ; . study:StudyDesignActivity a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:StudyActivity ; skos:prefLabel "Study design activity" ; . study:StudyDuration a owl:Class ; rdfs:subClassOf time:Duration ; skos:prefLabel "Study duration" ; . study:StudyEnd a owl:Class ; rdfs:subClassOf study:ActivityEnd ; skos:prefLabel "Study end" ; . study:StudyIdentifier a owl:Class ; rdfs:subClassOf study:Identifier ; skos:prefLabel "Study identifier" ; . study:StudyInterval a owl:Class ; rdfs:subClassOf study:ActivityInterval ; skos:prefLabel "Study interval" ; . study:StudyParticipationBegin a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:BeginInstant ; skos:definition "" ; skos:prefLabel "Study participation begin" ; . study:StudyParticipationEnd a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:EndInstant ; skos:definition "" ; skos:prefLabel "Study participation end" ; . study:StudyParticipationInterval a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:EntityInterval ; skos:definition "" ; skos:prefLabel "Study participation interval" ; . study:StudyPopulation a owl:Class ; rdfs:subClassOf study:Population ; skos:prefLabel "A Group of Subjects that participate in at least one Study Activity" ; . study:StudyRegistryIdentifier a owl:Class ; rdfs:subClassOf study:Identifier ; skos:prefLabel "Study registry identifier" ; . study:StudyStopRule a owl:Class ; rdfs:subClassOf study:StopRule ; skos:prefLabel "Study stop rule" ; . study:StudySubject a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Subject ; skos:prefLabel "Study subject" ; . study:Subcategory a owl:Class ; rdfs:subClassOf study:Entity ; skos:altLabel "" ; skos:prefLabel "Subcategory" ; . study:Subject a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:Entity ; skos:definition "An Entity of interest for participation in a Study, about whom an Investigator collects data for the purpose of conducting research. " ; skos:note "same as BRIDG Subject, which can be a human, non-human animal, or inanimate object (e.g. drug substance or product or device, etc.). A Subject need not participate in a Study although often does. " ; skos:prefLabel "Subject" ; . study:SubjectIdentifier a owl:Class ; rdfs:subClassOf study:Identifier ; skos:prefLabel "Subject identifier" ; . study:Substance a owl:Class ; rdfs:subClassOf study:Entity ; skos:altLabel "" ; skos:prefLabel "Substance" ; . study:SubstanceQuantity a owl:Class ; rdfs:subClassOf study:Entity ; skos:prefLabel "Substance quantity" ; . study:TemperatureOutcome a owl:Class ; rdfs:subClassOf study:NumericOutcome ; rdfs:subClassOf study:VitalSignOutcome ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom code:TemperatureUnit ; owl:onProperty code:hasUnit ; ] ; skos:prefLabel "Temperature outcome" ; . study:TherapeuticIntervention a owl:Class ; rdfs:subClassOf study:Intervention ; skos:definition " An Intervention whose intent is to have an effect (e.g. treat, cure, mitigate, prevent) on a Medical Condition." ; skos:prefLabel "Therapeutic intervention" ; . study:Title a owl:Class ; rdfs:subClassOf study:Entity ; skos:prefLabel "Title" ; . study:TrueArm a owl:Class ; rdfs:subClassOf study:Arm ; skos:prefLabel "True arm" ; . study:UnderlyingCondition a owl:Class ; a sh:NodeShape ; rdfs:subClassOf study:MedicalCondition ; skos:prefLabel "Underlying condition" ; . study:UniqueSubjectIdentifier a owl:Class ; rdfs:subClassOf study:Identifier ; skos:prefLabel "Unique subject identifier" ; . study:UnscheduledVisitActivity a owl:Class ; rdfs:subClassOf study:VisitActivity ; skos:altLabel "" ; skos:prefLabel "UNSCHEDULED VISIT ACTIVITY" ; . study:Visit a owl:Class ; rdfs:subClassOf study:StudyDesignActivity ; skos:definition "Any StudyActivity whose main focus is an interaction with the investigational staff, usually intended to collect and/or assess observations. " ; skos:note "A Visit may be virtual (phone, teleconference etc.)" ; skos:prefLabel "VISIT" ; . study:VisitActivity a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:StudyActivity ; skos:definition "A study activity that takes place or begins during a visit" ; skos:note "A drug administration activity may begin during the visit and may continue past the visit end date." ; skos:prefLabel "Visit Activity" ; . study:VisitDate a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:ActivityDate ; skos:definition "" ; skos:prefLabel "Visit begin" ; . study:VitalSign a owl:Class ; rdfs:comment "" ; rdfs:subClassOf study:Observation ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom study:VitalSignOutcome ; owl:onProperty code:outcome ; ] ; skos:definition "" ; skos:prefLabel "VitalSign" ; . study:VitalSignOutcome a owl:Class ; rdfs:subClassOf study:ObservationOutcome ; skos:prefLabel "Vital sign outcome" ; . study:WeightOutcome a owl:Class ; rdfs:subClassOf study:NumericOutcome ; rdfs:subClassOf study:VitalSignOutcome ; rdfs:subClassOf [ a owl:Restriction ; owl:allValuesFrom code:WeightUnit ; owl:onProperty code:hasUnit ; ] ; skos:prefLabel "Weight mass outcome" ; . study:actionTaken a owl:DatatypeProperty ; rdfs:domain study:AdverseEvent ; rdfs:range xsd:string ; skos:prefLabel "action taken" ; . study:actionTakenOther a owl:DatatypeProperty ; rdfs:domain study:AdverseEvent ; rdfs:range xsd:string ; skos:prefLabel "action taken other" ; . study:activityDescription a owl:DatatypeProperty ; rdfs:domain study:Activity ; rdfs:range xsd:string ; skos:prefLabel "activity description" ; . study:activityStatus a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudyActivity ; rdfs:range study:ActivityStatus ; skos:definition "" ; skos:prefLabel "activity status" ; . study:actualArm a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:EnrolledSubject ; rdfs:range study:Arm ; skos:definition "" ; skos:prefLabel "actual arm" ; . study:actualPopulationSize a owl:DatatypeProperty ; rdfs:domain study:Population ; rdfs:range xsd:integer ; skos:prefLabel "actual population size" ; . study:adaptiveDesign a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:NoYesResponse ; skos:prefLabel "adaptive design" ; . study:addOn a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:NoYesResponse ; skos:prefLabel "add on" ; . study:administeredDrug a owl:ObjectProperty ; rdfs:domain study:FixedDoseDrugAdministration ; rdfs:range study:Product ; skos:prefLabel "has route of administration" ; . study:adverseEventPattern a owl:DatatypeProperty ; rdfs:domain study:AdverseEvent ; rdfs:range xsd:string ; skos:prefLabel "adverse event pattern" ; . study:afflictedBy a owl:ObjectProperty ; rdfs:domain study:Subject ; rdfs:range study:MedicalCondition ; skos:prefLabel "afflicted by" ; . study:ageGroup a owl:ObjectProperty ; rdfs:domain study:Population ; rdfs:range code:AgeGroup ; skos:prefLabel "age group" ; . study:agecalc a spin:Function ; spin:body [ a sp:Select ; sp:resultVariables ( [ sp:varName "age" ; ] ) ; sp:where ( [ a sp:Bind ; sp:expression [ a xsd:date ; sp:arg1 [ a sp:substr ; sp:arg1 [ sp:varName "birthdate" ; ] ; sp:arg2 1 ; sp:arg3 10 ; ] ; ] ; sp:variable [ sp:varName "bdate" ; ] ; ] [ a sp:Bind ; sp:expression [ a xsd:date ; sp:arg1 [ a sp:substr ; sp:arg1 [ sp:varName "refdate" ; ] ; sp:arg2 1 ; sp:arg3 10 ; ] ; ] ; sp:variable [ sp:varName "rfd" ; ] ; ] [ a sp:Bind ; sp:expression [ a smf:duration ; sp:arg1 "y" ; sp:arg2 [ sp:varName "bdate" ; ] ; sp:arg3 [ sp:varName "rfd" ; ] ; ] ; sp:variable [ sp:varName "age" ; ] ; ] ) ; ] ; spin:constraint [ a spl:Argument ; spl:predicate arg:birthdate ; spl:valueType xsd:string ; rdfs:comment "calculates age from birthdate and reference start date" ; ] ; spin:constraint [ a spl:Argument ; spl:predicate arg:refdate ; spl:valueType xsd:string ; ] ; spin:returnType xsd:integer ; rdfs:comment "" ; rdfs:subClassOf spl:DateFunctions ; skos:definition "" ; skos:prefLabel "agecalc" ; . study:anatomicLocation a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Observation ; rdfs:range code:AnatomicLocation ; skos:definition "" ; skos:prefLabel "anatomic location" ; . study:assesses a owl:ObjectProperty ; rdfs:domain study:Observation ; rdfs:range study:Assessment ; owl:inverseOf study:assessmentInput ; skos:prefLabel "assesses" ; . study:assessmentInput a owl:ObjectProperty ; rdfs:domain study:Observation ; rdfs:range study:Assessment ; skos:prefLabel "assessment input" ; . study:baselineFlag a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:Observation ; rdfs:range xsd:string ; skos:definition "" ; skos:prefLabel "baseline flag" ; . study:blinding a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:TrialBlindingSchema ; skos:prefLabel "blinding" ; . study:bodyPosition a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Observation ; rdfs:range code:BodyPosition ; skos:definition "" ; skos:prefLabel "body position" ; . study:cancer a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; rdfs:subPropertyOf study:seriousCriterion ; skos:prefLabel "cancer associated" ; . study:causality a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:Causality ; skos:prefLabel "causality" ; . study:concomitantTreatmentGiven a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; skos:prefLabel "concomitant treatment given" ; . study:congenitalDefect a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; rdfs:subPropertyOf study:seriousCriterion ; skos:prefLabel "cancer associated" ; . study:controlType a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:ControlType ; skos:prefLabel "control type" ; . study:crfLocation a owl:ObjectProperty ; rdfs:domain study:StudyComponent ; rdfs:range study:CRFLocation ; skos:prefLabel "CRF Origin" ; . study:dataCollectionDay a owl:DatatypeProperty ; rdfs:domain study:StudyComponent ; rdfs:range xsd:integer ; rdfs:subPropertyOf study:day ; skos:prefLabel "data collection day" ; . study:dateTimeInXSDString a owl:DatatypeProperty ; rdfs:comment "this is particularly useful for partial dates that would result in an error if represented using the xsd:dateTime datatype" ; rdfs:domain time:Instant ; skos:definition "relates a date resource with its representation as a character string " ; . study:dateiso a spin:Function ; spin:body [ a sp:Select ; sp:resultVariables ( [ sp:varName "ISOdate" ; ] ) ; sp:where ( [ a sp:Bind ; sp:expression [ a xsd:date ; sp:arg1 [ a sp:substr ; sp:arg1 [ sp:varName "datestring" ; ] ; sp:arg2 1 ; sp:arg3 10 ; ] ; ] ; sp:variable [ sp:varName "ISOdate" ; ] ; ] ) ; ] ; spin:constraint [ a spl:Argument ; spl:predicate arg:datestring ; spl:valueType xsd:string ; rdfs:comment "Takes date string in ISO 8601 format, truncates off any time elements and returns an ISO 8601 date. " ; ] ; spin:returnType xsd:date ; rdfs:comment "" ; rdfs:subClassOf spl:DateFunctions ; skos:definition "" ; skos:prefLabel "ISODate" ; . study:day a owl:DatatypeProperty ; rdfs:domain study:StudyComponent ; rdfs:range xsd:integer ; skos:prefLabel "study day" ; . study:death a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; rdfs:subPropertyOf study:seriousCriterion ; skos:prefLabel "disabling" ; . study:deathFlag a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:Subject ; rdfs:range xsd:string ; skos:definition "" ; skos:prefLabel "death flag" ; . study:derivedFlag a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:StudyActivity ; rdfs:range xsd:string ; skos:definition "describes that the method of obtaining the results of the test involve a derivation from other observations" ; skos:prefLabel "derived flag" ; . study:disabling a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; rdfs:subPropertyOf study:seriousCriterion ; skos:prefLabel "disabling" ; . study:dosageQuantity a owl:DatatypeProperty ; rdfs:domain study:FixedDoseDrugAdministration ; rdfs:range xsd:integer ; skos:prefLabel "dosage quantity" ; . study:duration a owl:DatatypeProperty ; rdfs:range xsd:integer ; skos:prefLabel "duration" ; . study:durationiso a spin:Function ; spin:body [ a sp:Select ; sp:resultVariables ( [ sp:varName "duration" ; ] ) ; sp:where ( [ a sp:Bind ; sp:expression [ a xsd:date ; sp:arg1 [ a sp:substr ; sp:arg1 [ sp:varName "datestring1" ; ] ; sp:arg2 1 ; sp:arg3 10 ; ] ; ] ; sp:variable [ sp:varName "date1" ; ] ; ] [ a sp:Bind ; sp:expression [ a xsd:date ; sp:arg1 [ a sp:substr ; sp:arg1 [ sp:varName "datestring2" ; ] ; sp:arg2 1 ; sp:arg3 10 ; ] ; ] ; sp:variable [ sp:varName "date2" ; ] ; ] [ a sp:Bind ; sp:expression [ a smf:duration ; sp:arg1 "d" ; sp:arg2 [ sp:varName "date1" ; ] ; sp:arg3 [ sp:varName "date2" ; ] ; ] ; sp:variable [ sp:varName "duration" ; ] ; ] ) ; ] ; spin:constraint [ a spl:Argument ; spl:predicate arg:datestring1 ; spl:valueType xsd:string ; rdfs:comment "converts two date strings into ISO date format and returns the duration. " ; ] ; spin:constraint [ a spl:Argument ; spl:predicate arg:datestring2 ; spl:valueType xsd:string ; ] ; spin:returnType xsd:gDay ; rdfs:comment "" ; rdfs:subClassOf spl:DateFunctions ; skos:definition "" ; skos:prefLabel "durationiso" ; . study:endDay a owl:DatatypeProperty ; rdfs:domain study:StudyComponent ; rdfs:range xsd:integer ; rdfs:subPropertyOf study:day ; skos:prefLabel "study end day" ; . study:engagesIn a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Party ; rdfs:range study:StudyActivity ; skos:definition "relates an Party with an Activity with which the Entity is involved, either actively or passively" ; skos:prefLabel "has activity" ; . study:ethnicity a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:domain study:Person ; rdfs:range study:EthnicOutcome ; skos:altLabel "" ; skos:prefLabel "ethnicity" ; . study:groupID a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:StudyComponent ; rdfs:range xsd:string ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "group ID" ; . study:hasActivity a owl:ObjectProperty ; a owl:TransitiveProperty ; rdfs:comment "" ; rdfs:domain study:Activity ; rdfs:range study:Activity ; owl:inverseOf study:isActivityOf ; skos:definition "Relates an Activity with another activity nested beneath it (i.e. a sub-activity)" ; skos:prefLabel "has activity" ; . study:hasActivityInterval a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudyActivity ; rdfs:range study:ActivityInterval ; rdfs:subPropertyOf study:hasInterval ; skos:definition "" ; skos:prefLabel "has activity interval" ; . study:hasAnnotatedCRF a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:AnnotatedCaseReportForm ; rdfs:subPropertyOf study:hasDocument ; skos:altLabel "" ; skos:prefLabel "has annotated CRF" ; . study:hasCategory a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudyComponent ; rdfs:range study:Subcategory ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "has subcategory" ; . study:hasCountry a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Site ; rdfs:range code:Country ; skos:definition "" ; skos:prefLabel "country" ; . study:hasDataCollectionDate a owl:ObjectProperty ; rdfs:domain study:StudyComponent ; rdfs:range study:DataCollectionDate ; rdfs:subPropertyOf study:hasPerformedDate ; skos:prefLabel "has data collection date" ; . study:hasDate a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudyComponent ; rdfs:range time:Instant ; skos:definition "" ; skos:prefLabel "has date" ; . study:hasDelay a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:Rule ; rdfs:range xsd:duration ; skos:definition "" ; skos:prefLabel "has delay" ; . study:hasDocument a owl:ObjectProperty ; rdfs:range study:Document ; skos:altLabel "" ; skos:prefLabel "has document" ; . study:hasDosageFrequency a owl:ObjectProperty ; rdfs:domain study:FixedDoseDrugAdministration ; rdfs:range code:DosageFrequency ; skos:prefLabel "has dosage frequency" ; . study:hasIdentifier a owl:ObjectProperty ; rdfs:range study:Identifier ; . study:hasInterval a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudyComponent ; rdfs:range time:Interval ; skos:definition "" ; skos:prefLabel "has interval" ; . study:hasInvestigator a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Site ; rdfs:range study:Investigator ; skos:definition "" ; skos:prefLabel "has investigator" ; . study:hasInvestigatorID a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Investigator ; rdfs:range study:InvestigatorIdentifier ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "has investigator ID" ; . study:hasLastName a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:Person ; rdfs:range xsd:string ; skos:definition "" ; skos:prefLabel "has last name" ; . study:hasLifespan a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:BiologicEntity ; rdfs:range study:Lifespan ; rdfs:subPropertyOf study:hasInterval ; skos:definition "" ; skos:prefLabel "has lifespan" ; . study:hasMember a owl:ObjectProperty ; rdfs:domain study:StudyPopulation ; rdfs:range study:StudySubject ; skos:prefLabel "has member" ; . study:hasParticipant a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudyActivity ; rdfs:range study:Subject ; owl:inverseOf study:participatesIn ; skos:definition "" ; skos:prefLabel "has study participant" ; . study:hasPerformedDate a owl:ObjectProperty ; rdfs:domain study:PerformedActivity ; rdfs:range study:PerformedActivityDate ; rdfs:subPropertyOf study:hasDate ; skos:prefLabel "Object property 1" ; . study:hasPerformer a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudyActivity ; rdfs:range study:Party ; owl:inverseOf study:performsActivity ; skos:definition "" ; skos:prefLabel "has performer" ; . study:hasPlannedDuration a owl:ObjectProperty ; rdfs:domain time:Interval ; rdfs:range time:Duration ; rdfs:subPropertyOf time:hasDuration ; skos:prefLabel "has planned duration" ; . study:hasPopulation a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:Population ; skos:prefLabel "has population" ; . study:hasPrereqExpectedOutcome a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Rule ; rdfs:range study:ActivityOutcome ; skos:definition "" ; skos:prefLabel "has anchor outcome" ; . study:hasPrereqExpectedStatus a owl:ObjectProperty ; rdfs:domain study:Rule ; rdfs:range code:ActivityStatus ; skos:prefLabel "has prereq expected status" ; . study:hasPrerequisite a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Rule ; rdfs:range study:StudyActivity ; skos:definition "links the start of an activity relative to another activity known as a Prerequisite. " ; skos:prefLabel "has Prerequisite" ; . study:hasPrimObjective a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:PrimaryObjective ; skos:prefLabel "has prim objective" ; . study:hasPrimOutcomeMeasure a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:PrimaryOutcomeMeasure ; skos:prefLabel "has prim outcome measure" ; . study:hasProtocolSpecifiedActivity a owl:ObjectProperty ; rdfs:domain study:Activity ; rdfs:range study:ProtocolSpecifiedActivity ; rdfs:subPropertyOf study:hasActivity ; skos:definition "relates a study with a group of protocol specified activities, such as Glucose test at the Screening visit. The glucose test is performed multiple times, once for each Subject" ; skos:prefLabel "has protocol specified activity" ; . study:hasReferenceInterval a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Subject ; rdfs:range study:ReferenceInterval ; rdfs:subPropertyOf study:hasInterval ; skos:definition "" ; skos:prefLabel "has lifespan" ; . study:hasReferenceTimePointEndDate a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range study:ReferenceEnd ; rdfs:subPropertyOf time:hasEnd ; skos:prefLabel "has reference time point end date" ; . study:hasRegistryID a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:StudyRegistryIdentifier ; rdfs:subPropertyOf study:hasIdentifier ; skos:prefLabel "has registry ID" ; . study:hasRouteOfAdministration a owl:ObjectProperty ; rdfs:domain study:FixedDoseDrugAdministration ; rdfs:range code:RouteOfAdministration ; skos:prefLabel "has route of administration" ; . study:hasScheduledDate a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:ScheduledActivity ; rdfs:range study:ScheduledActivityDate ; rdfs:subPropertyOf study:hasDate ; skos:definition "" ; skos:prefLabel "has planned date" ; . study:hasSecObjective a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:SecondaryObjective ; skos:prefLabel "has sec objective" ; . study:hasSecOutcomeMeasure a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:SecondaryOutcomeMeasure ; skos:prefLabel "has sec outcome measure" ; . study:hasSite a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Party ; rdfs:range study:Site ; skos:definition "The organization (e.g. hospital, clinic) where a Human Study Subject goes to participate in many Study Activities." ; skos:prefLabel "has Site" ; . study:hasSiteID a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Site ; rdfs:range study:SiteIdentifier ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "has site ID" ; . study:hasSponsor a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:Sponsor ; skos:prefLabel "has sponsor" ; . study:hasStartRule a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Activity ; rdfs:range study:StartRule ; skos:definition "" ; skos:prefLabel "has start rule" ; . study:hasStopRule a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Activity ; rdfs:range study:StopRule ; skos:definition "" ; skos:prefLabel "has start rule" ; . study:hasStudyActivity a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Study ; rdfs:range study:StudyActivity ; rdfs:subPropertyOf study:hasActivity ; owl:inverseOf study:isActivityOfStudy ; owl:propertyChainAxiom ( study:hasStudyParticipant study:engagesIn ) ; skos:definition "Relates a Study with an Activity conducted as part of that Study" ; skos:prefLabel "has study activity" ; . study:hasStudyID a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Study ; rdfs:range study:StudyIdentifier ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "has study ID" ; . study:hasStudyParticipant a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Study ; rdfs:range study:StudySubject ; owl:inverseOf study:participatesInStudy ; skos:definition "relates a study with a StudySubject as a participant in the Study" ; skos:prefLabel "has study participant" ; . study:hasStudyParticipationInterval a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudySubject ; rdfs:range study:StudyParticipationInterval ; rdfs:subPropertyOf study:hasInterval ; skos:definition "" ; skos:prefLabel "has study participation interval" ; . study:hasSubRule a owl:ObjectProperty ; rdfs:domain study:CompositeRule ; rdfs:range study:Rule ; rdfs:subPropertyOf study:hasActivity ; . study:hasSubcategory a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudyActivity ; rdfs:range study:Subcategory ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "has subcategory" ; . study:hasSubjectID a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Subject ; rdfs:range study:SubjectIdentifier ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "has unique subject ID" ; . study:hasTitle a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:Title ; skos:prefLabel "has title" ; . study:hasUniqueSubjectID a owl:InverseFunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Subject ; rdfs:range study:UniqueSubjectIdentifier ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "has unique subject ID" ; . study:healthySubject a owl:ObjectProperty ; rdfs:domain study:Party ; rdfs:range code:NoYesResponse ; skos:prefLabel "healthy subject" ; . study:hospitalization a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; rdfs:subPropertyOf study:seriousCriterion ; skos:prefLabel "hospitalization associated" ; . study:interventionModel a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:InterventionModel ; skos:prefLabel "intervention model" ; . study:interventionType a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:InterventionType ; skos:prefLabel "intervention type" ; . study:isActivityOf a owl:ObjectProperty ; a owl:TransitiveProperty ; rdfs:comment "" ; rdfs:domain study:StudyActivity ; rdfs:range study:StudyActivity ; skos:definition "relates an Activity with Another Activity of which it is a part" ; skos:prefLabel "is activity of" ; . study:isActivityOfStudy a owl:ObjectProperty ; rdfs:comment "" ; rdfs:range study:Study ; rdfs:subPropertyOf study:isActivityOf ; skos:definition "relates StudyActivity with the Study of which it is a part. " ; skos:prefLabel "is part of" ; . study:isPrespecified a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; skos:prefLabel "is prespecified" ; . study:laterality a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudyActivity ; rdfs:range code:Laterality ; skos:definition "" ; skos:prefLabel "laterality" ; . study:lifeThreatening a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; rdfs:subPropertyOf study:seriousCriterion ; skos:prefLabel "life threatening" ; . study:longTitle a owl:DatatypeProperty ; rdfs:domain study:Title ; rdfs:range xsd:string ; rdfs:subPropertyOf skos:prefLabel ; skos:prefLabel "long title" ; . study:maxSubjectAge a owl:ObjectProperty ; rdfs:domain study:Population ; rdfs:range study:MaximumSubjectAge ; skos:prefLabel "max age subjects" ; . study:medicallyImportantSeriousEvent a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; skos:prefLabel "is a medically important serious adverse event" ; . study:memberOf a owl:ObjectProperty ; rdfs:domain study:BiologicEntity ; rdfs:range study:Group ; owl:inverseOf study:hasMember ; skos:prefLabel "member of" ; . study:minSubjectAge a owl:ObjectProperty ; rdfs:domain study:Population ; rdfs:range study:MinimumSubjectAge ; skos:prefLabel "min age subjects" ; . study:modifiedTerm a owl:DatatypeProperty ; rdfs:domain study:AdverseEvent ; rdfs:range xsd:string ; skos:prefLabel "reported term modified" ; . study:narms a owl:DatatypeProperty ; rdfs:domain study:Study ; rdfs:range xsd:integer ; skos:prefLabel "narms" ; . study:overdose a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; rdfs:subPropertyOf study:seriousCriterion ; skos:prefLabel "overdose associated " ; . study:participatesIn a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Subject ; rdfs:range study:StudyActivity ; rdfs:subPropertyOf study:engagesIn ; owl:propertyChainAxiom ( study:participatesIn study:hasActivity ) ; skos:definition "relates an Entity with an Activity that the Entity participates in passively; i.e. the activity is performed on the Entity" ; skos:prefLabel "participates in" ; . study:participatesInStudy a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:StudySubject ; rdfs:range study:Study ; owl:inverseOf study:hasStudyParticipant ; skos:definition "" ; skos:prefLabel "participates in study" ; . study:performsActivity a owl:ObjectProperty ; rdfs:comment "" ; rdfs:domain study:Party ; rdfs:range study:StudyActivity ; rdfs:subPropertyOf study:engagesIn ; owl:inverseOf study:hasPerformer ; skos:definition "relates an Entity with an Activity that the Entity engages actively. " ; skos:prefLabel "performs activity" ; . study:plannedPopulationSize a owl:DatatypeProperty ; rdfs:domain study:Population ; rdfs:range xsd:integer ; skos:prefLabel "planned population size" ; . study:race a owl:ObjectProperty ; rdfs:domain study:Person ; rdfs:range study:RaceOutcome ; skos:altLabel "" ; skos:prefLabel "race" ; . study:randomizedTrial a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:NoYesResponse ; skos:prefLabel "randomized trial" ; . study:reasonNotDone a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:StudyActivity ; rdfs:range xsd:string ; skos:definition "" ; skos:prefLabel "reason not done" ; . study:referenceID a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:StudyComponent ; rdfs:range xsd:string ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "reference ID" ; . study:relationshipToNonStudyDrug a owl:DatatypeProperty ; rdfs:domain study:AdverseEvent ; rdfs:range xsd:string ; skos:prefLabel "relationship to non study drug" ; . study:reportedTerm a owl:DatatypeProperty ; rdfs:domain study:AdverseEvent ; rdfs:range xsd:string ; skos:prefLabel "reported term" ; . study:ruleDescription a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:Rule ; rdfs:range xsd:string ; skos:definition "" ; skos:prefLabel "rule description" ; . study:ruleDescriptionLong a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:Rule ; rdfs:range xsd:string ; skos:definition "" ; skos:prefLabel "rule description long" ; . study:seq a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:StudyComponent ; rdfs:range xsd:float ; skos:definition "relates a resource to a sequence number used for sorting similar resources" ; skos:prefLabel "seq" ; . study:serious a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:NoYesResponse ; skos:prefLabel "serious" ; . study:seriousCriterion a owl:ObjectProperty ; skos:prefLabel "serious criterion" ; . study:severity a owl:ObjectProperty ; rdfs:domain study:AdverseEvent ; rdfs:range code:Severity ; skos:prefLabel "severity" ; . study:sex a owl:FunctionalProperty ; a owl:ObjectProperty ; rdfs:domain study:Subject ; rdfs:range study:SexOutcome ; skos:altLabel "" ; skos:prefLabel "sex" ; . study:sexGroup a owl:ObjectProperty ; rdfs:domain study:Population ; rdfs:range code:SexGroup ; skos:prefLabel "Sexgroup" ; . study:shortTitle a owl:DatatypeProperty ; rdfs:domain study:Title ; rdfs:range xsd:string ; rdfs:subPropertyOf skos:altLabel ; skos:prefLabel "short title" ; . study:sponsordefinedID a owl:DatatypeProperty ; rdfs:comment "" ; rdfs:domain study:StudyComponent ; rdfs:range xsd:string ; rdfs:subPropertyOf study:hasIdentifier ; skos:definition "" ; skos:prefLabel "sponsordefined ID" ; . study:startDay a owl:DatatypeProperty ; rdfs:domain study:StudyComponent ; rdfs:range xsd:integer ; rdfs:subPropertyOf study:day ; skos:prefLabel "study start day" ; . study:studyDrug a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range study:InvestigationalSubstance ; skos:prefLabel "study drug" ; . study:studyIndication a owl:ObjectProperty ; rdfs:domain study:Substance ; rdfs:range study:Indication ; skos:prefLabel "study indication" ; . study:studyType a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:StudyType ; skos:prefLabel "study type" ; . study:studyday a spin:Function ; spin:body [ a sp:Select ; sp:resultVariables ( [ sp:varName "studyday" ; ] ) ; sp:where ( [ a sp:Bind ; sp:expression [ a xsd:date ; sp:arg1 [ a sp:substr ; sp:arg1 [ sp:varName "activityDate" ; ] ; sp:arg2 1 ; sp:arg3 10 ; ] ; ] ; sp:variable [ sp:varName "date" ; ] ; ] [ a sp:Bind ; sp:expression [ a xsd:date ; sp:arg1 [ a sp:substr ; sp:arg1 [ sp:varName "refDate" ; ] ; sp:arg2 1 ; sp:arg3 10 ; ] ; ] ; sp:variable [ sp:varName "rfd" ; ] ; ] [ a sp:Bind ; sp:expression [ a smf:duration ; sp:arg1 "d" ; sp:arg2 [ sp:varName "rfd" ; ] ; sp:arg3 [ sp:varName "date" ; ] ; ] ; sp:variable [ sp:varName "std" ; ] ; ] [ a sp:Bind ; sp:expression [ a sp:if ; sp:arg1 [ a sp:lt ; sp:arg1 [ sp:varName "std" ; ] ; sp:arg2 0 ; ] ; sp:arg2 [ sp:varName "std" ; ] ; sp:arg3 [ a sp:add ; sp:arg1 [ sp:varName "std" ; ] ; sp:arg2 1 ; ] ; ] ; sp:variable [ sp:varName "studyday" ; ] ; ] ) ; ] ; spin:constraint [ a spl:Argument ; spl:predicate arg:activityDate ; spl:valueType xsd:string ; rdfs:comment "Takes a study activity date and calculates the study day based on the subject's reference start date. " ; ] ; spin:constraint [ a spl:Argument ; spl:predicate arg:refDate ; spl:valueType xsd:string ; rdfs:comment "the subject's reference start date in a study." ; ] ; rdfs:comment "" ; rdfs:subClassOf spl:DateFunctions ; skos:definition "takes two date strings in ISO 8601 format and calculates the study day using activity date as the first argument and reference date as the 2nd argument" ; skos:prefLabel "studyday" ; . study:toxGrade a owl:DatatypeProperty ; rdfs:domain study:AdverseEvent ; rdfs:range xsd:integer ; skos:prefLabel "tox grade" ; . study:trialPhase a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:TrialPhase ; skos:prefLabel "study phase" ; . study:trialType a owl:ObjectProperty ; rdfs:domain study:Study ; rdfs:range code:TrialType ; skos:prefLabel "trial type" ; .