Accelerated Review Process for Core-only Studies

Adult (MCW/Froedtert Hospital) Studies

The application process is largely the same as for any other submission, but if the protocol qualifies for Accelerated Review, the protocol will undergo a much streamlined GCRC review process.

The Principal Investigator will submit the following documents to the eIRB:

• SmartForm, with CTSI checked off under 26. Ancillary Committees
• CTSI Request Summary and Protocol with specific service/core request link
• Current 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:

• 2 Review Committee members assigned by the Chair
• Adult TRU Co-Director
• TRUs Administrative Director
• CTSI Research Subject Advocate (RSA)
• TRUs Scientific Administrator
• Director of requested service or core
• 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.

Once the protocol has been formally approved, the eBridge process will automatically be advanced to review by the IRB. You will be notified when the CTSI has approved your protocol.

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