Serious Adverse Events

All serious adverse events (SAEs) must be reported immediately using the HREC-05 Serious Adverse Events Reporting Form. The report should be submitted within three (3) calendar days — and no later than fifteen (15) days — of the event. Additional follow-up reports will be required until the matter is resolved.

Failure to submit reports may result in suspension of ethical clearance or withdrawal of approval.

Serious Adverse Events