Accelerated Review Process for Core-only Studies

Pediatric TRU Studies (Children's Hospital)

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 TRUs Scientific Administrator, Dr. Glenn Krakower (805-3802; gkrakowe@mcw.edu):

• CTSI Request Summary and Protocol with specific service/core request link
• Current consent form(s) link
• Current assent form(s) link
• 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 Scientific Review Committee members
• Pediatric TRU Co-Director
• TRUs Administrative Director
• 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.

Once the protocol has been formally approved, you will be notified by the CTSI TRUs. If changes in an approved consent form are requested, you will then need to submit the amended consent to the CHW IRB.

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