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.
Please reference the PRC Review Requirements by Protocol Type to determine the protocol type and level of review required.
Therapeutic and Interventional Studies
Requires Full Committee Review unless otherwise determined
- 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 - click to download
Non Interventional Non-Therapeutic studies and Observational Studies
Requires administrative review conducted by the Office of Quality Assurance and Training unless otherwise determined
- Protocol (if separate document from the HIC application)
- A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader - click to download
Ancillary and Correlative Studies
Refer to the PRC Review Requirements by Protocol Type to determine the type of review needed
- Protocol (if separate document from the HIC application)
- A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader - click to download
National Clinical Trials Network Studies
Requires review by PRC chair or vice chair unless otherwise determined
- 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 - click to download
