Reporting Non-Local Adverse Events That Occur in a UAMS/Affiliate Multi-Site Study 
When UAMS/Affiliate is the lead institution in a multi-site study, the PI has the responsibility for assuring adherence to IRB policy 10.2 (which can be accessed at http://www.uams.edu/irb/IRB.asp) that deals with required reporting of unanticipated events that occur during a study.  Part A(2) of policy 10.2 directs the Principal Investigator (PI) to report any of the unanticipated problems listed in part A(1) of the policy to the IRB even after the subject has completed the study or has withdrawn from the study until closed in the IRB files.  As the lead investigator, the UAMS/Affiliate PI must have a plan for oversight of the multi-sites such that all Adverse events are revealed to the IRB.  The oversight plan is covered by IRB policy 7.8 ( http://www.uams.edu/irb/IRB.asp ).  Adverse events that occur at a non-local site might affect the willingness of participants in all sites to continue in a study that has had potentially serious adverse effects.  Therefore, any event as defined in policy 10.2 that occurs in a multi-center site must be reported to the UAMS IRB.

Jimmie Valentine, Ph.D.
February 8, 2005