Dr. Q received IRB approval to conduct a clinical trial at Hospital Z to test drug A vs. drug B on October 31, 2001. Subject recruitment has been completed however, due to an adverse event on May 3, 2003, the IRB requested that the principal investigator re-consent subjects.
I think it depends on the adverse event.. was the event like someone broke in and stole all of the consent forms or Dr.Q’s ID#/Name list?
That sounds about right though.