Guidelines for Submission
- Initial Submissions
- Amendment Submission
- Accrual Monitoring – Closure Review
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.
- 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 (contact prc.ycc.committees@yale.edu for the DART form) with the required signatures of the PI and Disease Aligned Research Team (DART) Leader - OR - Study Intake Form and Study Review Form with the required signatures
- Approval Form for Expedited Review for Multicenter Externally Peer Reviewed or Multicenter Institutional Studies