31  AE & SAE Identification and Reporting

31.1 Definitions (Operational)

• Adverse Event (AE): Any unfavorable medical occurrence
• Serious Adverse Event (SAE): Results in death, life-threatening condition, hospitalization, disability, or is medically significant

31.2 CRA Oversight Objectives

• Site recognizes and reports events per protocol
• Reporting timelines are met
• Documentation is complete and traceable

31.3 CRA Monitoring Checks

• All AEs documented in source and EDC
• SAEs reported to sponsor within required timelines
• SAE forms complete (onset date, outcome, seriousness criteria)
• Supporting source documentation present
• Follow-up information obtained when required

NoteOncology-Specific Considerations

• High volume of expected toxicities → risk of under-reporting
• Hospitalizations may be protocol-expected but still require documentation
• Immune-related AEs (irAEs) often require prolonged follow-up

NoteVaccine Trial Consideration

Because vaccine trials frequently involve healthy populations, unexpected safety signals may require rapid escalation and governance review, even when event severity is low.