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.

If you have submitted a study to the IRB that has been flagged for PRMC review in myIRB and/or HRPO staff have indicated that PRMC review is necessary, please note that you will need to make a SEPARATE submission to PRMC through OnCore.  More information on this requirement, how to obtain OnCore access and resources for creating an Initial Review for PRMC may be found here.

Initial reviews

• Initial Review Request Form_(Word Document) 
• Initial Submission Grid (Word document)
• Confluence Work Instructions – PRMC Initial Submission

Change reviews

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

• Change Review Request Form (Word document)
• Change Review Submission Grid (Word document)
• Confluence Work Instructions – PRMC Change Review Submission

Continuation reviews

To be submitted concurrently with the annual IRB renewal submission.

• Continuation Review Request Form

• • 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.
• Continuation Review Submission Grid (Word document)
• Confluence Work Instructions – PRMC Continuation Review Submission