Problems, risks or events that occur during the conduct of the research, but were not expected and therefore are not cited in the written protocol, the consent form(s) or the Investigator's Brochure. Unanticipated events also include problems, risks or adverse events that were expected but occur with greater severity or frequency than originally anticipated.
Unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria:
The inappropriate use of prestige, wealth, ability or position to directly or indirectly affect the potential participants' decision to participate.
A procedure in which one or more parties to the trial are made aware of the treatment assignment(s).