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.