{ "_comment": "Educational USDM v4.0 study excerpt (USDM Play). Not an official CDISC file, but structurally checked against the USDM UML naming conventions and published CORE conformance rules.", "_conformance_notes": "Checked: root = Study instance with usdmVersion/systemName/systemVersion as siblings; exactly one sponsor StudyRole (code C70793) pointing to exactly one Organization; exactly one sponsor StudyIdentifier scoped to that Organization; exactly one 'Official Study Title' (C207616); StudyDesign.model/intentTypes (not interventionModel/trialIntentTypes); every StudyArm x StudyEpoch combination has exactly one StudyCell (2x3=6, no duplicates, no gaps); every StudyElement referenced by at least one StudyCell; every StudyIntervention referenced by a StudyElement is actually defined; BiomedicalConcepts collected on StudyDesign (no natural parent) and referenced by Activity.biomedicalConceptIds; every ScheduleTimeline has exactly one Fixed Reference anchor with no window; every non-terminal ScheduledActivityInstance has a defaultConditionId XOR the terminal one has a timelineExitId, never both; at least one ScheduleTimelineExit defined; all three epochs are referenced by at least one ScheduledActivityInstance; exactly one Primary Objective referencing exactly one Primary Endpoint. Best-effort, unverified against the authoritative USDM_CT.xlsx: the exact API cross-reference attribute name for StudyRole.appliesTo, and the specific C-code values used for StudyIntervention.role/type and StudyDesign.studyType/studyPhase (the codelist references themselves are correct; always confirm exact code values before production use).", "id": "Study_1", "instanceType": "Study", "name": "PLAY-101", "versions": [ { "id": "StudyVersion_1", "instanceType": "StudyVersion", "versionIdentifier": "1.0", "rationale": "First-in-human dose escalation study of Compound X in healthy volunteers.", "titles": [ { "id": "Title_1", "instanceType": "StudyTitle", "text": "A Phase 1 Study of Compound X in Healthy Adult Volunteers", "type": { "code": "C207616", "decode": "Official Study Title", "codeSystem": "cdisc.org" } } ], "studyIdentifiers": [ { "id": "Identifier_1", "instanceType": "StudyIdentifier", "text": "PLAY-101", "scopeId": "Organization_1" } ], "organizations": [ { "id": "Organization_1", "instanceType": "Organization", "name": "USDM Play Sponsor Inc.", "type": { "code": "C54149", "decode": "Pharmaceutical Company", "codeSystem": "cdisc.org" } } ], "studyRoles": [ { "id": "StudyRole_1", "instanceType": "StudyRole", "code": { "code": "C70793", "decode": "Clinical Study Sponsor", "codeSystem": "cdisc.org" }, "organizationIds": ["Organization_1"], "appliesToStudyVersionId": "StudyVersion_1" } ], "studyDesigns": [ { "id": "StudyDesign_1", "instanceType": "InterventionalStudyDesign", "name": "Main Design", "label": "Dose Escalation Design", "studyType": { "code": "C98388", "decode": "Interventional Study", "codeSystem": "cdisc.org" }, "studyPhase": { "code": "C15600", "decode": "Phase I Trial", "codeSystem": "cdisc.org" }, "model": { "code": "C82639", "decode": "Parallel Study", "codeSystem": "cdisc.org" }, "intentTypes": [ { "code": "C49654", "decode": "Pharmacokinetics", "codeSystem": "cdisc.org" } ], "arms": [ { "id": "StudyArm_1", "instanceType": "StudyArm", "name": "Arm A", "label": "Compound X", "type": { "code": "C174266", "decode": "Experimental Arm", "codeSystem": "cdisc.org" } }, { "id": "StudyArm_2", "instanceType": "StudyArm", "name": "Arm B", "label": "Placebo", "type": { "code": "C174265", "decode": "Placebo Comparator Arm", "codeSystem": "cdisc.org" } } ], "epochs": [ { "id": "StudyEpoch_1", "instanceType": "StudyEpoch", "name": "Screening", "type": { "code": "C48262", "decode": "Screening", "codeSystem": "cdisc.org" }, "nextId": "StudyEpoch_2" }, { "id": "StudyEpoch_2", "instanceType": "StudyEpoch", "name": "Treatment", "type": { "code": "C101526", "decode": "Treatment", "codeSystem": "cdisc.org" }, "previousId": "StudyEpoch_1", "nextId": "StudyEpoch_3" }, { "id": "StudyEpoch_3", "instanceType": "StudyEpoch", "name": "Follow-up", "type": { "code": "C99158", "decode": "Follow-up", "codeSystem": "cdisc.org" }, "previousId": "StudyEpoch_2" } ], "elements": [ { "id": "StudyElement_1", "instanceType": "StudyElement", "name": "EL_SCREEN", "label": "Screening", "transitionStartRule": { "id": "TR_1", "instanceType": "TransitionRule", "text": "Signing of informed consent" }, "transitionEndRule": { "id": "TR_2", "instanceType": "TransitionRule", "text": "Randomization" } }, { "id": "StudyElement_2", "instanceType": "StudyElement", "name": "EL_DRUG", "label": "Compound X dosing", "transitionStartRule": { "id": "TR_3", "instanceType": "TransitionRule", "text": "Randomization to Arm A" }, "transitionEndRule": { "id": "TR_4", "instanceType": "TransitionRule", "text": "Last dose of Compound X" }, "studyInterventionIds": ["StudyIntervention_1"] }, { "id": "StudyElement_3", "instanceType": "StudyElement", "name": "EL_PBO", "label": "Placebo dosing", "transitionStartRule": { "id": "TR_5", "instanceType": "TransitionRule", "text": "Randomization to Arm B" }, "transitionEndRule": { "id": "TR_6", "instanceType": "TransitionRule", "text": "Last dose of placebo" }, "studyInterventionIds": ["StudyIntervention_2"] }, { "id": "StudyElement_4", "instanceType": "StudyElement", "name": "EL_FU", "label": "Follow-up", "transitionStartRule": { "id": "TR_7", "instanceType": "TransitionRule", "text": "Last dose administered" }, "transitionEndRule": { "id": "TR_8", "instanceType": "TransitionRule", "text": "End of study" } } ], "studyCells": [ { "id": "StudyCell_1", "instanceType": "StudyCell", "armId": "StudyArm_1", "epochId": "StudyEpoch_1", "elementIds": ["StudyElement_1"] }, { "id": "StudyCell_2", "instanceType": "StudyCell", "armId": "StudyArm_1", "epochId": "StudyEpoch_2", "elementIds": ["StudyElement_2"] }, { "id": "StudyCell_3", "instanceType": "StudyCell", "armId": "StudyArm_1", "epochId": "StudyEpoch_3", "elementIds": ["StudyElement_4"] }, { "id": "StudyCell_4", "instanceType": "StudyCell", "armId": "StudyArm_2", "epochId": "StudyEpoch_1", "elementIds": ["StudyElement_1"] }, { "id": "StudyCell_5", "instanceType": "StudyCell", "armId": "StudyArm_2", "epochId": "StudyEpoch_2", "elementIds": ["StudyElement_3"] }, { "id": "StudyCell_6", "instanceType": "StudyCell", "armId": "StudyArm_2", "epochId": "StudyEpoch_3", "elementIds": ["StudyElement_4"] } ], "encounters": [ { "id": "Encounter_1", "instanceType": "Encounter", "name": "Screening Visit", "type": { "code": "C25716", "decode": "Visit", "codeSystem": "cdisc.org" }, "scheduledAtId": "Timing_1" }, { "id": "Encounter_2", "instanceType": "Encounter", "name": "Day 1", "type": { "code": "C25716", "decode": "Visit", "codeSystem": "cdisc.org" }, "scheduledAtId": "Timing_2" }, { "id": "Encounter_3", "instanceType": "Encounter", "name": "Day 8", "type": { "code": "C25716", "decode": "Visit", "codeSystem": "cdisc.org" }, "scheduledAtId": "Timing_3" }, { "id": "Encounter_4", "instanceType": "Encounter", "name": "Follow-up Visit", "type": { "code": "C25716", "decode": "Visit", "codeSystem": "cdisc.org" }, "scheduledAtId": "Timing_4" } ], "studyInterventions": [ { "id": "StudyIntervention_1", "instanceType": "StudyIntervention", "name": "Compound X", "role": { "code": "C41161", "decode": "Experimental Intervention", "codeSystem": "cdisc.org" }, "type": { "code": "C1909", "decode": "Pharmacologic Substance", "codeSystem": "cdisc.org" } }, { "id": "StudyIntervention_2", "instanceType": "StudyIntervention", "name": "Placebo", "role": { "code": "C41161", "decode": "Experimental Intervention", "codeSystem": "cdisc.org" }, "type": { "code": "C29848", "decode": "Placebo", "codeSystem": "cdisc.org" } } ], "activities": [ { "id": "Activity_1", "instanceType": "Activity", "name": "Informed Consent", "nextId": "Activity_2" }, { "id": "Activity_2", "instanceType": "Activity", "name": "Vital Signs", "biomedicalConceptIds": ["BC_HeartRate", "BC_SystolicBP"], "previousId": "Activity_1", "nextId": "Activity_3" }, { "id": "Activity_3", "instanceType": "Activity", "name": "PK Blood Sample", "previousId": "Activity_2", "definedProcedures": [ { "id": "Procedure_1", "instanceType": "Procedure", "name": "Venous blood draw", "procedureType": "Blood sampling", "studyInterventionId": "StudyIntervention_1" } ] } ], "biomedicalConcepts": [ { "id": "BC_HeartRate", "instanceType": "BiomedicalConcept", "name": "Heart Rate", "code": { "standardCode": { "code": "C49677", "decode": "Heart Rate", "codeSystem": "cdisc.org" } } }, { "id": "BC_SystolicBP", "instanceType": "BiomedicalConcept", "name": "Systolic Blood Pressure", "code": { "standardCode": { "code": "C25298", "decode": "Systolic Blood Pressure", "codeSystem": "cdisc.org" } } } ], "population": { "id": "Population_1", "instanceType": "StudyDesignPopulation", "name": "Main Population", "description": "Healthy adult volunteers eligible for Phase 1 dosing.", "plannedSex": [ { "code": "C20197", "decode": "Male", "codeSystem": "cdisc.org" }, { "code": "C16576", "decode": "Female", "codeSystem": "cdisc.org" } ], "includesHealthySubjects": true, "plannedAge": { "instanceType": "Range", "minValue": { "instanceType": "Quantity", "value": 18, "unit": { "code": "C29848", "decode": "Year", "codeSystem": "cdisc.org" } }, "maxValue": { "instanceType": "Quantity", "value": 55, "unit": { "code": "C29848", "decode": "Year", "codeSystem": "cdisc.org" } } }, "plannedEnrollmentNumber": { "instanceType": "Quantity", "value": 24 }, "criteria": ["EligibilityCriterion_1"] }, "eligibilityCriterionItems": [ { "id": "EligibilityCriterionItem_1", "instanceType": "EligibilityCriterionItem", "text": "Male or female, aged 18 to 55 years, in good general health as determined by medical history and physical examination." } ], "eligibilityCriteria": [ { "id": "EligibilityCriterion_1", "instanceType": "EligibilityCriterion", "identifier": "IN01", "category": { "code": "C25532", "decode": "Inclusion", "codeSystem": "cdisc.org" }, "criterionItemId": "EligibilityCriterionItem_1" } ], "objectives": [ { "id": "Objective_1", "instanceType": "Objective", "level": { "code": "C85826", "decode": "Primary Objective", "codeSystem": "cdisc.org" }, "text": "To assess the safety and tolerability of ascending doses of Compound X compared with placebo in healthy adult volunteers.", "endpoints": [ { "id": "Endpoint_1", "instanceType": "Endpoint", "level": { "code": "C94496", "decode": "Primary Endpoint", "codeSystem": "cdisc.org" }, "text": "Incidence of treatment-emergent adverse events through Day 8." } ] } ], "scheduleTimelines": [ { "id": "ScheduleTimeline_1", "instanceType": "ScheduleTimeline", "name": "Main Timeline", "mainTimeline": true, "entryCondition": "Subject identified and consented", "plannedDuration": { "id": "Duration_1", "instanceType": "Duration", "quantity": { "instanceType": "Quantity", "value": 36, "unit": { "code": "C25301", "decode": "Day", "codeSystem": "cdisc.org" } } }, "exits": [ { "id": "Exit_1", "instanceType": "ScheduleTimelineExit", "label": "End of Main Timeline" } ], "instances": [ { "id": "SAI_1", "instanceType": "ScheduledActivityInstance", "encounterId": "Encounter_1", "epochId": "StudyEpoch_1", "activityIds": ["Activity_1"], "defaultConditionId": "SAI_2" }, { "id": "SAI_2", "instanceType": "ScheduledActivityInstance", "encounterId": "Encounter_2", "epochId": "StudyEpoch_2", "activityIds": ["Activity_2", "Activity_3"], "defaultConditionId": "SAI_3" }, { "id": "SAI_3", "instanceType": "ScheduledActivityInstance", "encounterId": "Encounter_3", "epochId": "StudyEpoch_2", "activityIds": ["Activity_2", "Activity_3"], "defaultConditionId": "SAI_4" }, { "id": "SAI_4", "instanceType": "ScheduledActivityInstance", "encounterId": "Encounter_4", "epochId": "StudyEpoch_3", "activityIds": ["Activity_2"], "timelineExitId": "Exit_1" } ], "timings": [ { "id": "Timing_1", "instanceType": "Timing", "type": { "code": "C201356", "decode": "Before", "codeSystem": "cdisc.org" }, "value": "P28D", "relativeToScheduledInstanceId": "SAI_2", "relativeFromScheduledInstanceId": "SAI_1" }, { "id": "Timing_2", "instanceType": "Timing", "type": { "code": "C201357", "decode": "Fixed Reference", "codeSystem": "cdisc.org" }, "value": "P0D", "relativeToScheduledInstanceId": "SAI_2", "relativeFromScheduledInstanceId": "SAI_2" }, { "id": "Timing_3", "instanceType": "Timing", "type": { "code": "C201355", "decode": "After", "codeSystem": "cdisc.org" }, "value": "P7D", "windowLower": "P1D", "windowUpper": "P1D", "relativeToScheduledInstanceId": "SAI_3", "relativeFromScheduledInstanceId": "SAI_2" }, { "id": "Timing_4", "instanceType": "Timing", "type": { "code": "C201355", "decode": "After", "codeSystem": "cdisc.org" }, "value": "P29D", "windowLower": "P2D", "windowUpper": "P2D", "relativeToScheduledInstanceId": "SAI_4", "relativeFromScheduledInstanceId": "SAI_2" } ] } ] } ] } ], "usdmVersion": "4.0", "systemName": "USDM Play (educational export)", "systemVersion": "1.1" }