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INFORMATION FOR

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.

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 -OR- Study Intake Form and Study Review Form with the required signatures


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 -OR- Study Intake Form and Study Review Form with the required signatures

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 -OR- Study Intake Form and Study Review Form with the required signatures

MultiCenter Trials and National Clinical Trials Network Studies

Requires expedited review by PRC unless otherwise determined


For information contact:

Niece Hanna, MSW

Research Oversight Committee Regulatory Analyst

Yale Center for Clinical Investigation

2 Church Street South, Suite 409

203.785.7408

prc.ycc.committees@yale.edu

Dismayra Martinez, MHE, CCRP

Research Oversight Committee Regulatory Analyst

Yale Center for Clinical Investigation

2 Church Street South, Suite 409

203.737.3537

prc.ycc.committees@yale.edu