Research

PRMC Submission Forms and Instructions

All submissions to the Protocol Review and Monitoring Committee must include the corresponding PRMC form listed below. You may download the forms directly from the website or a copy of the form can be e-mailed to you from the Protocol Office.

The corresponding submission grids detail what documents, in addition to the PRMC form, must be included in the submission, depending on the type of study.

To create a new submission within OnCore please use the Confluence work instructions, which provide step-by-step directions and screenshots.

Change Reviews

To be submitted concurrently with all IRB modification submissions (except study team updates and marketing materials).

Continuation Reviews

To be submitted concurrently with the annual IRB renewal submission.

    • The Continuation Review Request Form can be generated via the OnCore Reports Console (Reports > PRMC > PRMC Continuation Review Form).
    • Enter the HRPO# and select DOCX as the file type.
    • While much of this form will be populated from data existing in OnCore, several fields still require manual entry.

Closures

Studies are eligible to close with PRMC once the study is permanently closed to accrual and the intervention or data collection has ended.