Serious Adverse Events at sites for which UP Ethics Committee gave approval, should be reported within 72 hours by submitting documents electronically.
A cover letter from the Principal Investigator must accompany the supporting documents.
SAHPRA guidelines for reporting SAE
It is the Principal Investigator’s duty to summarize and interpret all documents that need to be evaluated by the Ethics Committee such as the reporting of Serious Adverse Events. Relevance and causality need to be placed in prospective even if the SAE occurred elsewhere.
SAHPRA definition of a SAE
Any untoward medical occurrence that at any dose:
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