A CRU submission must have the following for the review process to begin:
- Identified funding for the study.
- Completed CRU submission and DSMP form.
- All other required submission materials.
Steps of the CRU Review Process - CRU submissions receive initial administrative review. After the CRU submission passes the initial administrative review, the principal investigator (PI) and submission preparer will be contacted by email and
• Sent a CRU protocol number • Asked for additional materials (e.g. draft research orders, lab manual) • Asked protocol related questions (e.g. Have subjects been seen at other sites? Does the PI have an NIH Common User Name?)
All subsequent communication with the CRU must reference the CRU protocol number.
Once all additional materials have been received and a more thorough administrative review of the completed CRU submission and budget has been conducted, the submission will be sent for: • Scientific review (unless it already received scientific review). • Utilization review. • Research Subject Advocate review.
- The principal investigator (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 principal investigator (PI) and submission preparers will receive the CRU approval and approved budget via e-mail.
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