@prefix top: . @prefix topc: . @prefix xsd: . # Demonstrates the v0.2-TOP per-Org-per-Study Sponsor architecture # with the Option A boolean responsibility flags, actsOnBehalfOf delegation, # and the multi-jurisdictional regulatoryAuthorityScope. # # Scenario: Pfizer is sponsor of record under FDA. Pfizer Ireland is sponsor # of record under EMA. IQVIA acts as operational sponsor (proxy) on behalf of # both for the same Study (urn:Study:ONCO-423). # === Organizations (corporate truth) === a topc:Organization ; topc:organizationId "urn:ngsi-ld:Organization:pfizer"^^xsd:anyURI ; topc:organizationName "Pfizer Inc" ; topc:legalName "Pfizer Inc." ; topc:organizationType "PARENT_CORPORATION" ; topc:identifierScheme "DUNS" ; topc:identifier "002472129" ; topc:legalAddress "{ \"line1\": \"66 Hudson Boulevard\", \"city\": \"New York\", \"region\": \"NY\", \"postalCode\": \"10001\" }" ; topc:country "USA" ; topc:website "https://www.pfizer.com"^^xsd:anyURI ; topc:status "ACTIVE" . a topc:Organization ; topc:organizationId "urn:ngsi-ld:Organization:pfizer-ireland"^^xsd:anyURI ; topc:organizationName "Pfizer Ireland Pharmaceuticals" ; topc:legalName "Pfizer Ireland Pharmaceuticals (Unlimited Company)" ; topc:organizationType "OPERATING_COMPANY" ; topc:identifierScheme "EMA_EUD" ; topc:identifier "ORG-100000326" ; topc:parentOrganization ; topc:legalAddress "{ \"line1\": \"Operations Support Group, Ringaskiddy\", \"city\": \"Cork\", \"region\": \"COR\", \"postalCode\": \"P43 K840\" }" ; topc:country "IRL" ; topc:website "https://www.pfizer.ie"^^xsd:anyURI ; topc:status "ACTIVE" . a topc:Organization ; topc:organizationId "urn:ngsi-ld:Organization:iqvia"^^xsd:anyURI ; topc:organizationName "IQVIA" ; topc:legalName "IQVIA Holdings Inc." ; topc:organizationType "CRO" ; topc:identifierScheme "DUNS" ; topc:identifier "017472988" ; topc:legalAddress "{ \"line1\": \"100 IMS Drive\", \"city\": \"Parsippany\", \"region\": \"NJ\", \"postalCode\": \"07054\" }" ; topc:country "USA" ; topc:website "https://www.iqvia.com"^^xsd:anyURI ; topc:status "ACTIVE" . # === Study (minimal, just enough for the runs relationship to resolve) === a top:Study ; top:studyId "urn:ngsi-ld:Study:ONCO-423"^^xsd:anyURI ; top:sponsorProtocolId "ONCO-423-001" ; top:clinicalTrialsGovId "NCT99999423" ; top:studyStatus "RECRUITING" ; top:hasProtocol ; top:hasArm , ; top:hasEndpoint ; top:hasInclusionCriterion ; top:hasSchedule . a top:Protocol ; top:protocolId "urn:ngsi-ld:Protocol:ONCO-423-v3"^^xsd:anyURI ; top:protocolVersion "3.0.0" ; top:protocolStatus "EFFECTIVE" . a top:Arm ; top:armId "urn:ngsi-ld:Arm:ONCO-423-treatment"^^xsd:anyURI ; top:armName "Treatment" ; top:armType "EXPERIMENTAL" . a top:Arm ; top:armId "urn:ngsi-ld:Arm:ONCO-423-comparator"^^xsd:anyURI ; top:armName "Standard of Care" ; top:armType "ACTIVE_COMPARATOR" . # === Sponsor entities (one per Org-per-Study role) === # Pfizer as US sponsor of record (FDA) a top:Sponsor ; top:sponsorId "urn:ngsi-ld:Sponsor:pfizer-onco423-fda"^^xsd:anyURI ; top:sponsorName "Pfizer (US sponsor of record, ONCO-423)" ; top:legalName "Pfizer Inc." ; top:sponsorType "PHARMACEUTICAL" ; top:address "{ \"line1\": \"66 Hudson Boulevard\", \"city\": \"New York\", \"region\": \"NY\", \"postalCode\": \"10001\" }" ; top:country "USA" ; top:phone "+1-212-733-2323" ; top:email "regulatory-ops@pfizer.com" ; top:website "https://www.pfizer.com"^^xsd:anyURI ; top:status "ACTIVE" ; top:isSponsorOfRecord true ; top:hasRegulatoryResponsibility true ; top:hasFinancialResponsibility true ; top:hasOperationalResponsibility false ; top:isInitiator true ; top:belongsToOrganization ; top:regulatoryAuthorityScope ; top:runs . # Pfizer Ireland as EU sponsor of record (EMA) a top:Sponsor ; top:sponsorId "urn:ngsi-ld:Sponsor:pfizer-ireland-onco423-ema"^^xsd:anyURI ; top:sponsorName "Pfizer Ireland (EU sponsor of record, ONCO-423)" ; top:legalName "Pfizer Ireland Pharmaceuticals (Unlimited Company)" ; top:sponsorType "PHARMACEUTICAL" ; top:address "{ \"line1\": \"Operations Support Group\", \"city\": \"Dublin\", \"region\": \"DUB\", \"postalCode\": \"D24\" }" ; top:country "IRL" ; top:phone "+353-1-467-6500" ; top:email "ema-ops@pfizer.com" ; top:website "https://www.pfizer.ie"^^xsd:anyURI ; top:status "ACTIVE" ; top:isSponsorOfRecord true ; top:hasRegulatoryResponsibility true ; top:hasFinancialResponsibility false ; top:hasOperationalResponsibility false ; top:isInitiator false ; top:belongsToOrganization ; top:regulatoryAuthorityScope ; top:runs . # IQVIA as operational proxy (acts on behalf of both) a top:Sponsor ; top:sponsorId "urn:ngsi-ld:Sponsor:iqvia-onco423-ops"^^xsd:anyURI ; top:sponsorName "IQVIA (operational sponsor, ONCO-423)" ; top:legalName "IQVIA Holdings Inc." ; top:sponsorType "CRO_AS_SPONSOR" ; top:address "{ \"line1\": \"100 IMS Drive\", \"city\": \"Parsippany\", \"region\": \"NJ\", \"postalCode\": \"07054\" }" ; top:country "USA" ; top:phone "+1-973-316-4000" ; top:email "onco423-ops@iqvia.com" ; top:website "https://www.iqvia.com"^^xsd:anyURI ; top:status "ACTIVE" ; top:isSponsorOfRecord false ; top:hasRegulatoryResponsibility false ; top:hasFinancialResponsibility false ; top:hasOperationalResponsibility true ; top:isInitiator false ; top:belongsToOrganization ; top:actsOnBehalfOf ; top:runs . # === Endpoint, InclusionCriterion, ScheduleOfAssessments (sub-objects of Study, lifted in v0.3.0) === a top:Endpoint ; top:endpointId "urn:ngsi-ld:Endpoint:ONCO-423-os"^^xsd:anyURI ; top:endpointName "Overall Survival" ; top:endpointDescription "Time from randomization to death from any cause." ; top:endpointType "PRIMARY" ; top:endpointMeasurementType "TIME_TO_EVENT" ; top:measurementUnit "months" ; top:timeFrame "Up to approximately 5 years post-randomization" ; top:statisticalApproach "Kaplan-Meier survival analysis with Cox proportional hazards model" . a top:InclusionCriterion ; top:criterionId "urn:ngsi-ld:InclusionCriterion:ONCO-423-i1"^^xsd:anyURI ; top:criterionNumber "I1" ; top:criterionText "Adults aged 18 years or older with histologically confirmed advanced non-small cell lung cancer (Stage IIIB or IV) and ECOG performance status 0-1." ; top:criterionCategory "DIAGNOSIS" ; top:waiverAllowed false . a top:ScheduleOfAssessments ; top:soaId "urn:ngsi-ld:ScheduleOfAssessments:ONCO-423-soa-v1"^^xsd:anyURI ; top:soaName "ONCO-423 Schedule of Assessments v1.0" ; top:soaVersion "1.0" ; top:soaStatus "EFFECTIVE" ; top:effectiveDate "2026-01-01"^^xsd:date ; top:description "Visit-by-procedure matrix covering Screening, Treatment, and Follow-up phases." .