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Research Compliance

 
 
 

SBER IRB and IBC Announce the Implementation of iRIS
A New Electronic Application System

Over the last several months, the Office of Research Administration has been developing iRIS, an electronic protocol submission and processing system that will digitize CWRU’s Social/Behavioral and Educational Research Institutional Review Board (SBER IRB) and CWRU’s Institutional Biosafety Committee (IBC). iRIS will improve business processes, submission efficiency, and review and renewal of IRB and IBC studies.


Training Sessions


The Office of Research Administration invites you to attend an upcoming iRIS training session to learn about using iRIS to enter and manage your studies. Interactive training sessions will be held weekly. Training sessions are listed and available for registration on the Office of Research Administration’s Seminar Calendar at: http://ora.ra.cwru.edu/research/orc/education/onlinecalendar.cfm.

Entering New Protocols


Beginning Monday, January 9, 2012, investigators will submit new applications through the iRIS system. Because a few protocols may be in development, submission of paper applications will be permitted until January 31, 2012.

Applications that are in the midst of committee review in paper form will be processed through approval in paper, but will need to be migrated into the electronic system upon approval.

Registering Currently Approved Paper Based Studies


Throughout the first quarter of 2012, currently approved studies will need to be migrated into the electronic system. As a first step, investigators are encouraged to terminate any study that has concluded, but is still open. For studies that will remain active, the SBER IRB and IBC administrative staff will input “shell” information into the iRIS system for each study (study title, study number, investigators, current consent documents and other study documents). Investigators will be notified when a study shell is available, and they can then complete the application questions in iRIS in order to finalize the registration process.

Approval and expiration dates will remain the same. Once studies are registered, any continuing actions will be completed within iRIS. This includes Continuing Reviews, Protocol Modifications (amendments or addenda), Adverse Events and Unanticipated Problems, and Protocol Terminations. The registration process is expected to be complete by April 30, 2012.

Ongoing Support and Assistance


The Office of Research Administration staff is dedicated to ensuring a smooth transition to iRIS. Our team of IT and Compliance specialists is available and ready to assist our faculty, staff and students in making this migration a success. In addition to the weekly training sessions listed above, we are available for telephone consultations, in-office visits and group training sessions (for your department, lab or school).

Regularly scheduled Office Hours will be held on Tuesdays from 2-3 pm and Fridays from 9-10 am in the Sears Library Building, Room 670. During office hours, one of our team members will be available for drop-in visits by investigators and study staff. Please bring your laptop, if possible. We will have one computer available for use in the conference room.

The iRIS Team


Tracy Wilson-Holden tjw18@case.edu 368-6131
Christian Swol cps16@case.edu 368-5307
Heidi Page hep14@case.edu 368-7600
Isabel Sanchez-Cummings ias5@case.edu 368-6993
Kim Volarcik kav6@case.edu 368-0134



Accessing the System


Enter the system using either of the web addresses below.
ibc-app.cwru.edu
sberirb-app.cwru.edu