# Example CEC charter for a T2DM CVOT
# For research / synthetic data only. Not for clinical decision making.

trial_id: DEMO-CVOT-001
trial_name: Demo CVOT for T2DM
sponsor: SyntheticPharma

# Primary endpoint composite (one of: 3p-MACE, 4p-MACE, 5p-MACE)
primary_endpoint: 3p-MACE

# Whether Type 2 MI counts toward the MI component
include_type2_mi: false

# Definitions used by the CEC
mi_definition: UDM-2018
stroke_definition: AHA-ASA-2013
hf_definition: ESC-2021-HHF

# CV death causal categories the CEC must select among
cv_death_categories:
  - fatal_MI
  - fatal_HF
  - sudden_cardiac_death
  - fatal_stroke
  - arrhythmia
  - undetermined
  - other_CV

# Adjudication workflow
adjudication:
  n_readers: 2
  blinded: true
  discordance_routing: 3rd_reader_then_panel
  calibration_interval_n_cases: 20
  target_turnaround_h: 72

# Sensitivity analyses to pre-specify
sensitivity:
  - flavor: 3p
    include_type2_mi: false
  - flavor: 3p
    include_type2_mi: true
  - flavor: 4p
    include_type2_mi: false
  - flavor: 5p
    include_type2_mi: false
