Hi Joy, Assessment of adverse events is an investigator/physician responsibility, so it shouldn't be ...
Thank you. You both have been very helpful. At our last no cause audit we were cited for "recommended ...
Hi Elisa, Because you asked for a regulatory citation, I am adding to the information which Christina ...
Hey Elisa, Hope this helps ..... According to guidance documents, you should be able to substantiate ...
Hello, During the Sponsor audit, the auditor stated it was a finding that we did not have a SOP in ...
Hi John, Great points and I've a comment and a question or two. I have a hypothesis based on my previous ...