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 

MultiCenter Trials and National Clinical Trials Network Studies

Requires review by PRC chair or vice chair unless otherwise determined 

For information contact:
Niece Hanna, MSW
Research Oversight Committee Regulatory Analyst 
Yale Center for Clinical Investigation 
2 Church Street South, Suite 112 
203.785.7408   
ycc.ycci.committees@yale.edu