21 Start-Up Risks & Mitigation
21.1 Common Start-Up Risks
- Delayed regulatory approvals
- Incomplete training
- System access issues
- Staff turnover
- Poor recruitment projections
21.2 CRA Risk Mitigation Strategies
- Early regulatory tracking
- Clear SIV follow-up
- Proactive communication with sites
- Escalation of delays
21.3 High-Risk Indicators
- Repeated activation delays
- Missing documentation
- Inexperienced staff
- Overcommitted investigators