What is the reporting requirement for global SAE?
Only global SAE which is assessed as SUSAR needs to be reported to MREC.
What is a final SUSAR report?
A final SUSAR report is one in which the final outcome of the SAE has become known to investigators and is reported on the 'final' SUSAR report. The final outcome of the SAE can only be one of the three possibilities, namely full recovery, recovery with sequelae, and death. As long as the final outcome of the SAE is still unknown, the SUSAR report shall still not be final.
Is there a need to submit a local Serious Adverse Event (SAE)/ Suspected Unexpected Serious Adverse Event (SUSAR) report from the Medical Research Ethics Committee (MREC) approved site?
Yes, the SAE report obtained from a MREC approved site should be promptly reported to MREC within the reporting timelines.
What would be the timeline for the reporting of SAE including “Non-life threatening SUSAR”?
For SAE and “Non-life threatening SUSAR”, initial report is to be submitted within 15 calendar days from awareness of the event and followed by a follow up report submission.
What would be the timeline for the reporting of “Life threatening SUSAR” or death?
For “Life threatening SUSAR” or death, initial report is to be submitted within 7 calendar days followed by a follow up report within the next 8 calendar days.