PRMC Submissions: A Basic Guide

Problem

What is PRMC? Is my study required to be submitted to PRMC? How do I submit to PRMC? What is the difference between PRMC and OnCore, and Who Do I Contact? Read on for answers to all of these questions and more.

Solution

PRMC (Protocol Review and Monitoring Committee) provides scientific review of research studies in diagnosis, therapy, prevention, and control of cancer. They also provide monitoring of cancer research studies at Washington University for scientific progress, and likewise maintain the authority to close any study not meeting accrual or performance standards. The most current PRMC Policies and Procedures can be found HERE. For more information, please view this PRMC Introduction video created by the PRMC Team.

Is My Study Required to be Submitted to PRMC?
All human-subject, cancer-related initial submissions to the Washington University Human Research Protection Office (HRPO: WashU's IRB) must be reviewed and approved by PRMC prior to final approval by HRPO. Cancer-related studies are defined as having a 30% or greater oncology patient population, or as having objectives that involve the study of diagnosis, prevention, screening, evaluation, treatment, or support of cancer patients. PRMC requires timely submission of renewals and amendments for these studies throughout the life of the study. Advertisements, case studies, and single-patient studies do not require PRMC approval.
How Do I Submit to PRMC?
All PRMC submissions must go through OnCore. If your study requires PRMC review, as defined above, you will submit your study to PRMC directly through the OnCore application. After submitting to PRMC, you will continue to use OnCore to communicate with PRMC about the status of your submission. For more information, please view this video created by the PRMC Team on Resolving Queries.
What is the Difference Between PRMC and OnCore?
As stated above, PRMC is a scientific review committee. OnCore is a clinical trials management system that PRMC uses as a tool to manage submissions and communicate about review status. You will need access to OnCore in order to make a PRMC submission. (If you are receiving this newsletter, you already have access to OnCore - contact the OST if you have questions about access.)
Who Should I Contact if I Have Questions?
Contact the OnCore Support Team oncore@wustl.edu with access and system specific questions: What OnCore role do I need in order to create a submission; where do I find the New Protocol Submission form; which fields are required to be filled out verses which can be left blank; what do the fields mean?
Contact PRMC protocoloffice@wudosis.wustl.edu with study and submission specific questions: Is my study required to be submitted to PRMC; how do I answer a certain field; what documentation do I need to provide along with my submission?
The general rule of thumb is that the OST can tell you what to do (e.g. what the questions on the New Protocol Submission form mean), and the PRMC Team can work with you on how to do something (e.g. how to answer for your specific study submission).

PRMC Contact Information:

Sharon Phillips, MS, CCRC

Laura Gross

314-747-3650

protocoloffice@wudosis.wustl.edu