1. Adverse Event Is it Serious? Record as an Adverse Event No Yes
i.e. resulted in:
Death
Life Threatening
Hospitalisation or prolongation of hospitalisation
Disability/incapacity
Congenital abnormality/birth defect
Important medical event/medical intervention
Yes No
Record as an Adverse Event
Is it Unexpected?
i.e. not previously documented
Is it possible that the event resulted from participation in the research?
Report to main Research Ethics
Committee within 15 days
Record as a Serious Adverse Event