Research and Regulatory Consultations
The CRRO provides consultations for PIs and research staff at any point during the life of the study. Get assistance with:
- IRB application preparation and submission, including pre-reviews of IRB applications before submission to the IRB. The CRRO can work with you to spot potential issues and provide advice on how to address them, facilitating review and shortening review time.
- Study implementation: when the study is in progress often questions come up about the conduct of the study, such as effective processes related to documentation, consenting, eligibility determination, and AE monitoring/reporting, etc.
- Guidance with sponsor-investigator responsibilities and obligations in conduct of FDA regulated research conducted under and IND or IDE, including assistance with preparation and submission of IND/IDE application to FDA and management of INDs/IDEs.
- And more… If you have a question about research, we will do our best to help you!