Accelerated Review Process: NIH/Federal Agency Peer Review Studies

Adult TRU Studies (MCW/Froedtert Hospital)

If the protocol qualifies for Accelerated Review, the protocol will undergo a much streamlined review process. This is intended mainly for studies with prior IRB approval, but we can still accelerate the process for new submissions.

NOTE: If the IRB has not already approved this study, please submit through the standard eBridge application procedure, making certain that CTSI is checked off under 27. Ancillary Committtees. If the study has IRB approval:

The Principal Investigator will submit the following documents directly to the CTSI Scientific Administrator, Dr. Glenn Krakower (805-3802; gkrakowe@mcw.edu):

• The SmartForm from the IRB-approved protocol
• IRB approval letter
• CTSI Request Summary link
• Full protocol/grant reviewed by the funding agency
• Funding agency letter or other documentation showing approval 
• Approved consent form(s)
• Protocol specific DSMP link
• A current NIH Biosketch is helpful
• Any other supporting documents that might be either necessary or at least useful for review (i.e. study flow charts, advertisements, questionnaires)

The Accelerated Review process will be conducted by:

• Adult TRU Co-Director
• 1 Scientific Review Committee member
• CTSI Administrative Director, who must be consulted during the preparation of the funding agency budget to avoid overutilization of CTSI resources and address cost sharing issues
• Adult TRU Nurse Manager to specifically assess the availability of personnel, facilities, equipment and supplies
• CTSI Research Subject Advocate (RSA)
• TRUs Scientific Administrator, to assure that complete documentation has been submitted for review
• Directors of the cores or services requested.

An initial evaluation will decide whether the study qualifies for accelerated review. If so, the application materials will be e-mailed to everyone involved in the accelerated review process. Their comments and reviews will be compiled (disposition form) and returned to the Review Committee Chair for final decision. Possible decisions are:

• Approval without revisions
• Approval with minor revisions, to be re-reviewed administratively
• Major revisions, to be re-directed for full Committee review
• Disapproval

It is estimated the entire review process will take no more than 2 weeks.

You will be notified once the protocol has been formally approved by the CTSI. At that time, if you have prior IRB approval, you must submit an amendment to the IRB indicating that the CTSI has been added as an Ancillary committee, so that the CTSI will be able to monitor all amendments and adverse events. This will not affect your IRB approval or delay protocol initiation.

If you have any questions, please contact Dr. Glenn Krakower (805-3802, gkrakowe@mcw.edu).