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CRU Protocols at Children's Memorial Hospital

Step 2: Review Process

The CRU Review Process at Children's Memorial Hospital

A CRU submission must have the following for the review process to begin:

  1. IRB approval.
  2. Identified funding for study.
  3. Completed CRU submission and DSMP form.
  4. All other required supporting documents.

Steps of the CRU Review Process:

  1. CRU submissions receive initial administrative review for completeness. After the CRU submission passes initial administrative review, the principal investigator (PI) and submission preparer will be sent a CRU protocol number via email.

    All subsequent communication with the CRU must reference the CRU protocol number.
     
  2. Once a more thorough administrative review of the completed CRU submission and budget have been completed, the submission will be sent for:

            Scientific review (unless it already received scientific review)   
            Utilization review
            Research Subject Advocate review  
              
  3. The PI and submission preparer may receive questions from reviewers during the process. The review process cannot move forward until all review issues are resolved.

  4. The PI and submission preparers will receive the CRU approval and budget via email.

 


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