Your add-ins should create no delay in Outlook shutdown that is perceptible to the user. Compare the time it takes for Outlook to shut down with only your add-in running, and the time it takes for Outlook to shut down without any add-ins running to identify any significant difference.
Reportable Event: A Reportable Event is a process (with an associated IRB form) used by an investigator to report any problem or event or other act or omission to the irb.
serious or continuing noncompliance with this policy or the requirements or. determinations of the IRB. [45 CFR 46.103(b)(5)] The industry has interpreted the above regulations to require investigators to report. âprotocol violationsâ to the IRB and sponsor.