Problem/Event Reports Tutorial Problem/Event Reports are submitted as Further Study Actions (FSA) for active IRB approved protocols. Multiple Problem/Event Reports may be submitted to the IRB in a single submission. Problem/Event Reports may be submitted together with a Continuing Review,Changes in Research, or Termination/Post-Termination Reports in a single submission. FSA-Problem/Event Reports may be submitted at any time. IND Safety Reports with no changes to consent form(s) or protocol ARE NOT submitted as FSAs. IND Safety Reports with changes to consent Form(s) or protocol ARE submitted as FSA-Changes in Research. IND Safety Reports | 
