Adverse Events

Adverse events

An event/reaction is serious if it:

• results in death,
• is life threatening,
• results in persistent or significant disability/incapacity,
• requires hospitalisation,
• prolongs a current hospitalisation,
• results in a congenital anomaly or birth defect.

The Trust's Research Related Adverse Events Reporting  Policy requires reports to be made within specific timescales.

• Adverse Event Recording Template - Appendix 1
• Instructions for completion of SAE forms - Appendix 2
• Serious Adverse Event Initial Report Form - Appendix 3
• Serious Adverse Event Follow up Report Form - Appendix 4
• Sponsor Report Form - Appendix 5
• Guidance on content of annual safety reports - Appendix 6
• Annual Safety Report form - Appendix 7