Should Adverse Event of Special Interest (AESI) be reported as SAE?
If the AESI is not serious and not considered as a SAE, it does not need to be reported to MREC. If PI wishes to report the said AESI as a SAE as per study protocol, then you may submit it through the SAE platform by ticking the special interest column.
Can corrections be made to an Initial Report of SAE/ SUSAR which has been submitted?
No, you would not be able to do any corrections to any reports which have been submitted, however you may proceed to submit a follow up report with the corrections and/ or new information available.
Is it allowed to submit global SUSARs in batches?
Yes, global SUSARs may be submitted in batches every quarter of the year (3 monthly once) or twice-yearly (6 monthly once).
If the SUSAR is from a clinical trial which is not being conducted in Malaysia, would that need to be reported to MREC or it has to be reported regardless of where the clinical trial is being done?
MREC does not receive foreign SUSAR reports, so it is not necessary to submit foreign SUSAR reports to MREC.
Can a Corresponding Person (CP) be able to locate a study when clicking onto “Global SUSAR Reporting”?
Only the sponsor contact, CRO, PI and global SUSAR coordinators would be able to locate a study and be allowed to submit global SUSAR accordingly.