PRC Guidelines for Initial Submission
Please submit the following electronically through OnCore’s Electronic Protocol Review and Monitoring System (ePRMS) Console. Forms can be found on the forms page. If you have questions or concerns regarding access to this console, please contact ycc.ycci.committees@yale.edu.
Therapeutic and Interventional Studies
Requires Full Committee Review unless otherwise determined
- A copy of the Protocol Review Committee Supplemental Submission Form
- Final protocol (not the HIC application)
- Investigator’s Brochure (as applicable)
- A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader
Non-Therapeutic Studies
Requires administrative review conducted by the Office of Quality Assurance and Training unless otherwise determined
- Protocol (if separate document from the HIC application)
- HIC Application
National Clinical Trials Network Studies
Requires review by PRC chair or vice chair unless otherwise determined
- A copy of the Protocol Review Committee Supplemental Submission Form
- Final protocol
- Investigator’s Brochure (as applicable)
- A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader
