Accelerated Review Process: Industry-supported 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.  However, the protocol can stil be accelerated if only Nursing is requested.

NOTE: If the IRB has not already approved this study, please submit through the standard eBridge application procedure. 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 
• Industry protocol, including the budget from the pharmaceutical company
• Current approved consent form(s)
• Protocol specific DSMP link
• A current NIH Biosketch is helpful

The accelerated review process will be conducted by:

• A physician member of the Scientific Review Committee
• Adult TRU Co-Director
• TRUs Administrative Director
• Adult TRU Nurse Manager, to assess availability of personnel, facilities, equipment, and supplies
• Research Subject Advocate (RSA)
• TRUs Scientific Administrator
• Director of the core or services requested
• CTSI Biostatistician  

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. The 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, 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).