# Phase 27: Clinical Trial Lifecycle Configuration

# Database
DATABASE_URL=postgresql://user:password@localhost:5432/clinical_trials
DATABASE_POOL_SIZE=10

# Security
SECRET_KEY=your-secret-key-here
ENCRYPTION_KEY=your-encryption-key-here

# Trial Configuration
MAX_SITES=100
MAX_PARTICIPANTS_PER_SITE=1000

# Consent
CONSENT_SIGNATURE_ALGORITHM=SHA256
COMPREHENSION_PASS_THRESHOLD=0.8

# AE Reporting
AUTO_REPORT_SAE=true
FDA_REPORT_GRADE_5=true

# EDC
DATA_VALIDATION_ENABLED=true
AUTO_QUERY_ON_VALIDATION_FAIL=true
CDISC_EXPORT_FORMAT=SDTM

# Audit
AUDIT_LOG_ENABLED=true
AUDIT_RETENTION_DAYS=2555

# Compliance
HIPAA_COMPLIANCE=true
GDPR_COMPLIANCE=true
CFR_21_PART_11=true
