. Report all events that are both serious and unexpected, regardless of probability of cause.

. A copy of every IND Safety Report from the sponsor regarding adverse events reported by other investigators should be forwarded to the IRB.

Adverse Events Occurring at Your Site

Adverse events that occur during the course of a research study that are both SERIOUS and UNEXPECTED must be promptly reported to Goodwyn IRB. For Serious and Unexpected adverse events, complete the Adverse Event Report Form and forward it within 5 days of observation. (Please use the Goodwyn IRB reporting form supplied below.)

Please note the following definitions:

Adverse Event: An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention

Disability: Substantial disruption of a person's ability to conduct normal life functions.

Life-threatening Adverse Event: An adverse drug experience that places subject, in the view of the investigator, at immediate risk of death. It does not include a reaction that, had it occurred in a more severe form, might have caused death.

Serious: Death, life-threatening drug reaction, in-patient hospitalization or prolongation of hospitalization, persistent or significant disability or incapacity, or congenital birth defect or anomaly.

Unexpected: Any adverse reaction, the degree or severity of which is not consistent with the current Investigator's Brochure and/or consent form.

Adverse Events Occurring External to Your Site

Under FDA regulations, study sponsors will inform you of Serious and Unexpected adverse events that have occurred at sites other than your own. When you receive the sponsor's report(s), you must forward them to Goodwyn IRB within 15 days of receipt. (Note: The research sponsor may forward IND safety reports on your behalf.)

Adverse Event Report Form *    **

* The DOC file format requires that you have Microsoft Word '97 or higher installed on your computer. If you do not, please use PDF format.
** The PDF file format requires that you have the Adobe Acrobat Reader installed on your computer. If you do not have this program installed, you may download and install a free copy by clicking the icon below: