data/medium_cases.json

{
  "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"
        }
      ]
    }
  ]
}