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Revision Date: March 13, 2001 Page 1 of 3 Serious Adverse Event Reporting Form

Summary: Revision Date: March 13, 2001 Page 1 of 3
Serious Adverse Event Reporting Form
Gene Transfer Protocol
Reporting of serious adverse events to the FDA, NIH OBA/RAC, the UVA Human Investigation Committee
(HIC) and the UVA Institutional Biosafety Committee (IBC) is a critical element of the Federal and
Institutional oversight of human gene transfer research. This form is provided to facilitate complete and
standardized adverse event reporting.
A Serious Adverse Event is defined as:
"any expected or unexpected adverse event, related or unrelated to the intervention, occurring at any dose
that results in any of the following outcomes; death, a life-threatening event, in-patient hospitalization or
prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital
anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require
hospitalization also may be considered a serious adverse event when, based upon appropriate medical
judgement, they may jeopardize the human gene transfer research subject and may require medical or
surgical intervention to prevent one of the outcomes listed in this definition."
Submit the following pages of this form within 24 hours:
HIC and IBC: Page 2 and 3
NIH OBA/ RAC: Page 3
FDA: Page 3
Contact Information:


Source: Acton, Scott - Department of Electrical and Computer Engineering, University of Virginia


Collections: Computer Technologies and Information Sciences