Guidelines for Accrual Monitoring – Closure Review

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

Please reference the ePRMS Submitter Overview for detailed instructions on submitting protocols in OnCore’s ePRMS for closure review.

Requires Full Committee Review unless otherwise determined. Trials of rare diseases and rare molecular sub-types are excluded.

• Accrual Monitoring Form

• Supporting Documentation (optional), including but not limited to:

Progress Reports from the Sponsor

Study Newsletters or Updates

Email correspondence from the Sponsor

Publications, manuscripts, etc.

Not subject to accrual monitoring. No review required.