MREC is in the midst of revising its timelines and we will be publishing it as soon as possible. For further enquiries, please e-mail mreciir@nih. gov.my
Serious Adverse Event (SAE) / Serious Unexpected Adverse Event Reaction (SUSAR) Reporting
All SAEs/ SUSARs (involving MREC approved sites) needs to reported immediately to MREC. The timeline is as following:
- SUSAR that is Fatal/Life threatening: Initial report as soon as possible but not later than 7 calendar days from awareness of event by investigator, followed by a complete report within 8 additional calendar days.
- All other SUSARs/ SAEs: no later than 15 calendar days from awareness of event by investigator