Public Faq Saer | National Medical Research Register

Serious Adverse Event (SAE) Reporting FAQ

Should Adverse Event of Special Interest (AESI) be reported as SAE?

Yes, all types of adverse events should be notified.

Can I make corrections to an Initial Report of SAE/ SUSAR which has been submitted?

No, you would not be able to do any corrections to the ones which has been submitted, however you may proceed to submit a new follow up report with the corrections and/ or new information if available.

Who will receive the Acknowledgement of Receipt (AOR) for local SAE/ SUSAR submission?

All the following individuals will receive the AOR: a. Principal / Coordinating Investigator (PI) b. Reporting Investigator c. Person who created or submitted the SAE Report (Can be CRO, Sponsor, PI, Site Investigator, SAEs/SUSARs Coordinator, SAEs/SUSARs Correspondence Person) d. Site SAE/SUSAR corresponding person

Where can we get a copy of the cover letter template for local SAEs/ SUSARs submission?

It is made available at Section VII of the SAE Reporting Platform.

I’m the Corresponding Person (CP) but I couldn’t locate the study when I clicked onto “Global SUSARs Reporting”. Why?

Only the sponsor contact, CRO, PI and global SUSAR coordinators would be able to locate the study and allowed to submit the global SUSARs.