Adverse Events

Although all adverse events should be summarized at continuing review, only a subset of adverse events (AEs) need to be promptly reported to the IRB using the ERICA Report Form application. The IRB requires the prompt reporting of adverse events that may represent unanticipated problems involving risks to participants or others (UPs).

How do I determine which adverse events are also “unanticipated problems”?

• Please see the IRB’s page regarding Unanticipated Problems (UP).

Is follow-up information concerning an adverse event required?

A follow-up report is NOT required unless you receive information that suggests that the severity of an event has increased, OR that suggests the event is more likely to be related to the study than currently thought, OR that the event seems to affect the rights and welfare of current participants.

Where can I find more information?

• Please see the IRB’s page regarding Unanticipated Problems (UP).