From: Office of Clinical Research
Sent: Tuesday, January 24, 2012 10:35 AM
To: OCR-PI-DL
Cc: Maleckar, Millie [BSD] - OCR
Subject: IRB Electronic Submissions
Importance: High
To: Clinical Research Faculty and Staff
From: Christopher Daugherty, MD
Professor of Medicine
Chairman, BSD Institutional Review Board
Walter Stadler, MD, FACP
Fred C. Buffett Professor of Medicine and Surgery
Associate Dean of Clinical Research
Date: January 24, 2012
Re: IRB Electronic Submissions
As many of you are aware, approximately 2 years ago, the University sought an enterprise wide solution for the processing of funding proposals, IRB protocols, and other activities in the University of Chicago research portfolio called AURA. The University has successfully implemented the grants module of the AURA product ( and is now ready to implement the human subjects’ (IRB) module. This will require converting data from IRBWise to the new product to assure that none of the information currently available in IRBWise is lost. Although we, the OCR, and the IRB staff have been working closely with URA to make the transition from IRBWise to AURA as seamless as possible, the complexity of the systems and the critical regulatory nature of the data means that there will be a time when no electronic IRB system will be available, which will impact your ability to submit material to the IRB. Importantly, the data conversion process itself will take 2 weeks and can only function accurately with submissions that have been fully completed by the IRB.
In order to comply with this requirement we therefore need to make you aware of the following key dates, which modify the previous IRB submission dates:
KEY DATES:
- Tuesday, February 28 (5:00 pm): – Deadline for any new protocols and amendments to be submitted for processing using the IRBWise system
- Tuesday, March 13 – Last IRB Committee meeting prior to IRBWise shut-down
- Friday, March 16 (5:00 pm) – IRBWise shut-down
- Tuesday, March 20 – Committee meeting to consider new protocols only - Communication of protocol determinations will occur via email.
- Tuesday, April 2 – AURA-IRB go live
- Thursday, April 5- Deadline for any new protocols to be submitted for processing for the first post-AURA-IRB go live IRB meeting
- Monday, April 9 – Deadline for new amendments to be submitted for processing for the first post-AURA-IRB go live IRB meeting
- Tuesday, April 24 – First IRB meeting to review new protocols and amendments entered in AURA-IRB
We strongly urge you to complete any submissions in IRBWise prior to 2/28/12. Any submissions started after 2/28/12 in IRBWise will not be accepted and the submission process must be restarted upon activation of the AURA-IRB system. On a case-by-case basis, and upon approval of the IRB director Millie Maleckar, submissions that have been started but not completed as of 2/28/12, and emergency situations, may be completed in IRBWise between 2/29/12 and 3/15/12. Any such submissions not completed by 3/16/12 will have to be re-entered in AURA-IRB upon its activation.
Members of the IRB leadership are developing standards for handling emergency situations that must be addressed between 3/16/12 and 4/2/12 during which time no electronic IRB system will be available. More information will follow at a later date.
We regret the inconvenience that this places on your research activities, but look forward to working with you during this important transition period as the University proceeds with the implementation of this new product. Over the next two months, additional communication will be forthcoming regarding training opportunities for the new system, differences between the current electronic and the new electronic system, and available resources to assist with navigating the new system.
If you have any questions regarding this implementation, please contact either of us or Millie Maleckar, Director of the BSD IRB at or 2-1472.
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