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Message-ID: <4908BF4A.8090305@columbia.edu>
Date: Wed, 29 Oct 2008 15:53:46 -0400
From: Alan Teller <at2059@columbia.edu>
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To: cuhs-irb@cumc.columbia.edu
Subject: RASCAL Update: IRB Module revised
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The IRB's Human Subjects Module in RASCAL has been modified as follows:

The Unanticipated Problems module (formerly the Adverse Event module) 
has been modified in accordance with the IRB's Policy, which was 
released on January 24, 2008.  The Policy can be viewed in its entirety 
at 
http://www.cumc.columbia.edu/dept/irb/documents/UnanticipatedProblemsPolicy.FINALVERSION.012408.pdf.  

Only Adverse Events and other incidents, experiences and outcomes 
involving risks to subjects or others that meet the criteria of an 
Unanticipated Problem as defined by this policy are reportable to the IRB.

George Gasparis
Executive Director, Human Subjects Protection Program
Columbia University IRB