A CRU submission must have the following for the review process to begin:
- IRB approval.
- Identified funding for study.
- Completed CRU submission and DSMP form.
- All other required supporting documents.
Steps of the CRU Review Process: - 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. - 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 - 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.
- The PI and submission preparers will receive the CRU approval and budget via email.
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