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Approved-By:  George Gasparis <gg2120@COLUMBIA.EDU>
Message-ID:  <4A56851A.4050607@columbia.edu>
Date:         Thu, 9 Jul 2009 20:02:34 -0400
Reply-To: George Gasparis <gg2120@columbia.edu>
From: George Gasparis <gg2120@columbia.edu>
Subject: Adverse event reporting for studies conducted at NewYork Presbyterian Hospital
To: cuhs-irb@CUMC.COLUMBIA.EDU
Precedence: list

Dear Colleagues:

Please be aware there are two policies (see links below) from 
NewYork-Presbyterian Hospital (NYP) which describe the adverse events 
which must be reported to the Hospital per NYS and other regulatory 
mandates. You are advised that these policies also apply to patients who 
are in a research study whether they are an inpatient at NYP or are an 
outpatient in the hospital's Ambulatory Care Network (ACN) at the time 
any such event occurs.

Links:
http://infonet.nyp.org/QA/HospManual/IncRpt/I125IncidentReportingToNYDOH.pdf
http://infonet.nyp.org/QA/HospManual/IncRpt/S120SentinelEvent.pdf

To make a report of such events or occurrences you should immediately:

1) Notify Patient Services Administration at the appropriate site by 
telephone, Monday - Friday 9AM - 5PM:

NYP/CUMC and MSCHONY extension 5-5904;
Allen Pavilion, extension 4-4321;
NYP/WCMC, extension 6-4293;
Payne Whitney/Westchester, extension 5920.

All other times, please contact the Administrator-on-Call through the 
page operator. At Payne Whitney/Westchester, contact the Doctor-on-Call 
at 914 682-9100.

2) Enter the event into the Hospital’s on-line Medical Event Reporting 
System (MERS-th) the link is: https://www.mers-th.org/mers-th/main

For any questions regarding NYPH reporting policies, please call:

Rose Ann Cannon
Corporate Director, 
Patient Services Regulatory Affairs 
New York Presbyterian Hospital 
177 Fort Washington Avenue
New York, NY  10032
Office: 212-305-5904
Fax: 212-305-5826

Unanticipated problems involving risks to subjects or others that may 
occur in any study conducted by Columbia faculty or NYPH staff that is 
reviewed by the Columbia IRB must also be reported in RASCAL in 
accordance with the Columbia IRB policy found at:
http://www.cumc.columbia.edu/dept/irb/policies/documents/UnanticipatedProblemsPolicy.FINALVERSION.012408.pdf

Sincerely,

George Gasparis
Executive Director, Columbia Human Research
Protection Program/IRB