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"description": "Medium task: detect dosage and classification mismatches across protocol and patient records with multiple deviation candidates.",
"task_level": "medium",
"cases": [
{
"case_id": "MED-001",
"objective": "Detect overdose and missing protocol deviation reporting.",
"protocol_excerpt": "Section 3.2: Investigational product dose must not exceed 120 mg/day. Section 8.1: Any dosing deviation must be reported to sponsor quality within 24 hours.",
"patient_records": [
{
"patient_id": "P042",
"dose_log": [
{
"date": "2026-03-02",
"dose_mg": 100
},
{
"date": "2026-03-03",
"dose_mg": 140
}
],
"site_comment": "Dose escalation entered by mistake and corrected next day.",
"deviation_report_submitted": false,
"deviation_report_time": null
}
],
"expected_deviations": [
{
"patient_id": "P042",
"clause_violated": "Section 3.2",
"severity": "critical",
"regulation_ref": "ICH E6(R2) 4.5.2"
},
{
"patient_id": "P042",
"clause_violated": "Section 8.1",
"severity": "major",
"regulation_ref": "ICH E6(R2) 5.18.4"
}
]
},
{
"case_id": "MED-002",
"objective": "Detect delayed serious adverse event reporting and delayed IRB notification.",
"protocol_excerpt": "Section 9.1: Serious adverse events must be reported within 24 hours of site awareness. Section 9.4: IRB notification for serious adverse events must occur within 7 calendar days.",
"patient_records": [
{
"patient_id": "P055",
"sae_event_date": "2026-03-11T10:00:00Z",
"site_awareness_date": "2026-03-11T13:30:00Z",
"sae_report_submitted": "2026-03-13T18:00:00Z",
"irb_notified_date": "2026-03-23",
"event_summary": "Hospitalization for severe rash."
}
],
"expected_deviations": [
{
"patient_id": "P055",
"clause_violated": "Section 9.1",
"severity": "critical",
"regulation_ref": "ICH E2A 1.5"
},
{
"patient_id": "P055",
"clause_violated": "Section 9.4",
"severity": "major",
"regulation_ref": "ICH E6(R2) 4.11"
}
]
},
{
"case_id": "MED-003",
"objective": "Detect laboratory threshold breach and missed follow-up laboratory repeat.",
"protocol_excerpt": "Section 4.3: ALT greater than 3 times upper limit of normal requires immediate dose interruption. Section 4.4: ALT elevation above 3 times upper limit of normal requires repeat liver panel within 48 hours.",
"patient_records": [
{
"patient_id": "P060",
"lab_results": {
"alt_uln": 40,
"alt_value": 165
},
"dose_status_after_lab": "continued",
"repeat_liver_panel_date": "2026-03-16",
"notes": "No interruption documented."
}
],
"expected_deviations": [
{
"patient_id": "P060",
"clause_violated": "Section 4.3",
"severity": "major",
"regulation_ref": "ICH E6(R2) 4.5.2"
},
{
"patient_id": "P060",
"clause_violated": "Section 4.4",
"severity": "major",
"regulation_ref": "ICH E6(R2) 4.3.1"
}
]
}
]
}
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