{
  "system": {
    "name": "Clinical Trial Lifecycle System",
    "version": "1.0.0",
    "phase_id": 27,
    "story_points": 45
  },
  "trial_management": {
    "max_sites": 100,
    "max_participants_per_site": 1000,
    "enable_randomization": true,
    "enable_stratification": true
  },
  "econsent": {
    "signature_algorithm": "SHA256",
    "comprehension_pass_threshold": 0.8,
    "supported_languages": ["en", "es", "zh", "fr", "de"],
    "version_control": true
  },
  "adverse_events": {
    "ctcae_version": "5.0",
    "auto_report_sae": true,
    "fda_report_grade_5": true,
    "enable_causality_assessment": true
  },
  "edc": {
    "enable_validation": true,
    "auto_query_on_fail": true,
    "enable_sdv": true,
    "enable_data_locking": true,
    "cdisc_export": true
  },
  "compliance": {
    "cfr_21_part_11": true,
    "gcp": true,
    "hipaa": true,
    "gdpr": true
  },
  "audit": {
    "enabled": true,
    "retention_days": 2555,
    "hash_algorithm": "SHA256"
  }
}
