Adverse Event Is it Serious? Record as an Adverse Event No Yes

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Presentation transcript:

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