Reporting of Serious Adverse Events

All on site* serious** adverse events must be reported to the IRB within 72 hours. All deaths must be reported to the IRB immediately by phone (716-829-2752) or by fax (716-829-3610). The only exception is for observational studies in which death is the end point. All off site adverse events must be reported to the IRB office as usual (i.e. med-watch reports) as required by protocol.

* on-site = any subject enrolled in an UB approved protocol.

** serious = any experience that suggest a significant hazard, contraindication, side effect, or precaution or a clinical experience that is fatal, life threatening, permanently disabling, requires hospitalization, is a congenital anomaly, cancer or overdose.

A Serious Adverse Event Report form is available for your use. Serious Adverse Event Report Form.  This report form should be used for all LOCAL serious averse events.

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