Adverse Event Monitoring Dashboard
Real-time safety monitoring + escalation protocols
צורך קלינית
Clinical trials צריכות adverse event monitoring. אם 5% של kids יעלו חרדה או dropout, זה must be caught and reported. מערכת שלנו אוטומטית תוגבר אלרטים.
Adverse Events
Anxiety spike
Indicator: EMA anxiety > 8/10 × 2 consecutive sessions
Alert therapist (24h)
Review medication, consider relaxation
Dropout risk
Indicator: Missed 3 sessions in 2 weeks OR HRV pattern = shutdown
SMS reminder + phone call
Re-engagement protocol
Aggression/Hostility
Indicator: Parent report "שלח לי הודעה גסה" OR game anger spikes
Urgent therapist review (Same day)
Crisis protocol
Suicidal ideation
Indicator: EMA response to "ever hurt yourself?"
Immediate (psychiatric)
Safety plan, parents contacted
Dashboard Metrics
Adverse Event Rate: 3.2% (typical) → below 1.5%
Time to Escalation: varies (2-7 days) → within 24 hours
Intervention Success: N/A → 80% kids re-engage after alert
Integration
- • Therapist dashboard: red/yellow/green status for each child
- • Automatic SMS if anxiety spike detected
- • Incident report auto-generated for regulatory compliance (IRB, FDA)
- • Historical log for clinical oversight
סטטוס קלינית
בדיוק דבר זה אפשר לך להגיש trial מסדר עיתונות / journal בטוח (JAMA, Pediatrics). Regulatory agencies רוצות שתוכנית באוטומציה תמנע mishaps.