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 :

a. Study or study unrelated; or

b. Suspected or unexpected

from the Principal Investigator must accompany the supporting documents on the PS system.

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:

• results in death,
• is life-threatening,
• requires inpatient hospitalization or prolongation of existing hospitalization,
• results in persistent or significant disability/incapacity, or
• is a congenital anomaly/birth defect (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).