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INFORMATION FOR

Guidelines for Submission

You can either do an initial submission or an amendment submission. Navigate the tabs below for more information.

Guidelines for Initial Submission

Please submit the following documents through OnCore’s Electronic Protocol Review and Monitoring System (ePRMS) Console. If you have questions or concerns regarding the ePRMS console, please contact prc.ycc.committees@yale.edu.

Please reference the PRC Initial Review Requirements by Protocol Type to determine the protocol type and level of review required. Please reference the ePRMS Submitter Overview for detailed instructions on submitting protocols in OnCore’s ePRMS for initial review.

Interventional Studies

Requires Full Committee Review unless otherwise determined.

  • Protocol (not the IRB application)
  • Investigator’s Brochure, Package Insert and/ or Instructions for Use (as applicable)
  • A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader – contact prc.ycc.committees@yale.edu for the DART form -OR- Study Intake Form and Study Review Form with the required signatures

Non-Interventional Studies and Observational Studies

Requires administrative review conducted by the Office of Quality Assurance and Monitoring unless otherwise determined.

  • Protocol (if separate document from the IRB application)
  • A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader - contact prc.ycc.committees@yale.edu for the DART form -OR- Study Intake Form and Study Review Form with the required signatures

Ancillary and Correlative Studies

Refer to the PRC Initial Review Requirements by Protocol Type to determine the type of review needed.

  • Protocol (if separate document from the IRB application)
  • A copy of the DART Protocol Review Form with the required signatures of the PI and Disease Aligned Research Team (DART) Leader - contact prc.ycc.committees@yale.edu for the DART form -OR- Study Intake Form and Study Review Form with the required signatures

Externally Peer-Reviewed and National Studies

Requires expedited review by PRC member unless otherwise determined.