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
For information contact:

LaToya Howard, BS, CCRP
Manager, Research Oversight Committees and Education
Yale Center for Clinical Investigation
2 Church Street South, Suite 112
203.737.3661
latoya.howard@yale.edu