34  Safety Follow-Up & Escalation

34.1 Follow-Up Triggers

• Incomplete SAE documentation
• Missing outcome information
• Unresolved ongoing events
• Recurrent reporting delays

34.2 CRA Escalation Criteria

Escalate when: - Reporting timelines repeatedly missed - Site does not respond to safety queries - Safety processes appear systematically weak - Subject safety may be compromised

34.3 Documentation

All follow-up actions must be: - Written - Dated - Tracked to resolution - Filed appropriately