NON-UVA/BATCH AE SUBMISSION FORM IRB-HSR #: PI Name: Protocol Title: AE ID AE Name/ Description Initial or Follow/up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up Initial Follow-up I certify that the above AEs occurred in a subject or subjects enrolled in a protocol at a site other than UVa and that the risk section of the consent and/or the protocol remains unchanged in light of these AEs. There are no new risks identified that require update to the protocol or consent at this time. Investigator signature: ____________________________________________ Date: Submitted by: Date: Website: http://www.virginia.edu/vpr/irb/hsr/index.html Phone: 434-924-2620 Fax: 434-924-2932 Box 800483 Version date: 05/25/10 Page 1 of 1
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