This message was posted by a user wishing to remain anonymous
Hi, I had submitted annual reports of INDs, IDEs, and SAEs on a regular basis but never submitted SAEs grade 5 reports (death of the subject possibly due to investigational drug and other complications). I was curious to know to whom to report the SAE grade 5 , will it be the same Regulatory Project Manager or another official? I really appreciate any help you can provide.
Thanks in Advance