Adverse events that occur during the course of a research study that are both UNEXPECTED (in nature and/or frequency) and RELATED to the research must be reported to Goodwyn IRB within 10 working days of observation. Do not report adverse events that are expected or not related.

IND Safety Reports from the sponsor do not need to be reported to Goodwyn Institutional Review Board unless they indicate that subjects or others are at an increased risk of harm. (Use the Alerts and Updates Report).

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:

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.