# GLP-1RA AE Signal Detection Charter (example)
# 본 charter는 GLP-1AESignal-Kor의 panel 정의·threshold·우선순위를 명시한다.
# 실제 임상시험에서는 DSC/Sponsor가 confirm 해야 한다.

study:
  protocol_id: "GLP1KOR-DEMO-001"
  phase: "Phase 3"
  arms:
    - semaglutide_2.4
    - tirzepatide_15
    - placebo
  follow_up_weeks: 72

de_identification:
  hash_algorithm: "sha1"
  subject_id_truncation: 10
  site_mask_truncation: 6

panels:
  pancreatitis:
    label: "췌장염"
    pt_codes: [PT0001, PT0002, PT0003, PT0004, PT0005, PT0006, PT0007, PT0008, PT0074, PT0075, PT0078]
    severity_classification: "Atlanta_2012"
    atlanta:
      mild:     { criteria: "No organ failure, no local complications" }
      moderate: { criteria: "Transient organ failure (<48h) OR local complications" }
      severe:   { criteria: "Persistent organ failure (>48h)" }
    biomarker_threshold:
      lipase_uln_multiplier: 3
      amylase_uln_multiplier: 3
    susar_window_days: 7
    priority: high

  thyroid:
    label: "갑상선 (MTC/C-cell)"
    pt_codes: [PT0009, PT0010, PT0011, PT0012, PT0013, PT0014]
    biomarker_threshold:
      calcitonin_flag_pg_mL: 50
    confound_adjustment: ["sex", "ckd"]
    us_trigger_pg_mL: 20
    priority: high

  gallbladder:
    label: "담낭염/담석증"
    pt_codes: [PT0015, PT0016, PT0017, PT0018, PT0019, PT0020, PT0079]
    priority: medium

  gi:
    label: "GI AE"
    pt_codes: [PT0021, PT0022, PT0023, PT0024, PT0025, PT0026, PT0027, PT0028, PT0029, PT0030]
    interruption_action_codes: ["dose_reduced", "dose_interrupted", "withdrawn"]
    site_heterogeneity_test: "cochran_q"
    priority: medium

  injection_site:
    label: "주사부위 반응"
    pt_codes: [PT0031, PT0032, PT0033, PT0034, PT0035, PT0036]
    priority: low

  retinopathy:
    label: "망막병증 악화"
    pt_codes: [PT0037, PT0038, PT0039, PT0040, PT0041, PT0042]
    historical_signal: "SUSTAIN-6 (Marso 2016)"
    priority: high

  suicidality:
    label: "Suicidality / 자해"
    pt_codes: [PT0043, PT0044, PT0045, PT0046, PT0047, PT0048, PT0080]
    instrument: "C-SSRS"
    susar_window_days: 7
    priority: high

signal_thresholds:
  irr_lower_ci_min: 1.0
  faers:
    prr_min: 2.0
    chi2_min: 4.0
    count_min: 3
    ebgm_min: 2.0

reporting:
  dsc_frequency: "quarterly"
  modules:
    - RMP
    - PSUR
    - DSUR
  signal_strength:
    strong:   "IRR LCI >=2 AND FAERS PRR >=4"
    emerging: "IRR LCI >=1 AND FAERS PRR >=2"
    no_signal: "otherwise"
