Guidelines for Initial Submission
Please submit the following electronically through OnCore’s Electronic Protocol Review and Monitoring System (ePRMS) Console.
If you have questions or concerns regarding access to this console, please contact prc.ycc.committees@yale.edu
- Please reference the PRC Review Requirements by Protocol Type to determine the protocol type and level of review required.
- Please reference the ePRMS submitter overview for instructions on submitting protocols in OnCore’s ePRMS.
On this page
Interventional Studies
Requires Full Committee Review unless otherwise determined
- Final protocol (not the HIC application)
- Investigator’s Brochure (as applicable)
- A copy of the Clinical Research Team (CRT) Study Intake Form and Study Review Form with the required signatures from REDCap
Non-Interventional 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 Clinical Research Team (CRT) Study Intake Form and Study Review Form with the required signatures from REDCap
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 Clinical Research Team (CRT) Study Intake Form and Study Review Form with the required signatures from REDCap
Externally Peer-Reviewed and National Studies
Requires expedited review by PRC unless otherwise determined
- Final protocol
- Investigator’s Brochure (as applicable)
- A copy of the Clinical Research Team (CRT) Study Intake Form and Study Review Form with the required signatures from REDCap
- Approval Form for Expedited Review for Multicenter Externally Peer Reviewed or Multicenter Institutional Studies
Contact Us
Alyssa Dore, Program Manager, Regulatory Oversight Committees at Yale Cancer Center, Clinical Trials Office