The purpose of the Protocol Review and Monitoring Committee (PRMC) is to provide internal scientific review for all clinical cancer studies within the Georgia Cancer Center, as further described below.
A major objective of this review is to prioritize studies to meet the institutional objective of designation as a (Comprehensive) Cancer Center by the National Cancer Institute (NCI). The review will maximize scientific validity, assure rapid and effective performance, and assess utilization of shared resources, and thus ensure the highest scientific quality of clinical research conducted at the Georgia Cancer Center.
All cancer-related clinical research protocols must be reviewed by the Georgia Cancer Center Protocol Review and Monitoring Committee (PRMC) prior to submission to the Institutional Review Board (IRB). Subject enrollment cannot begin until both PRMC and IRB approvals have been obtained and a Study Activation Notice has been received for that protocol.
1.) Completed Initial PRMC Submission Form
2.) Completed Routing Sheet
a. A completed routing sheet will be submitted with all protocol or Letter of Intent (LOI) submissions. Any submission NOT including a completed routing sheet will NOT be reviewed by the PRMC.
b. Note that there is a different routing sheet to use for Cooperative Studies.
3.) Letter of Support from Disease-Oriented Working Group (DOWG) Leader
4.) Biostatistician Letter of Support (for Investigator-Initiated Trials Only)
5.) Department Advocacy Letter (in the absence of a specific DOWG Leader)
6.) Protocol and Appendices
7.) Investigator Brochure, if applicable
All submitted protocols must be in final format. No draft protocols or pre-finalized versions will be accepted. LOI submissions will use the CTEP template. Informed consent documents will NOT be reviewed by the PRMC.
All documents must be received by the circulated deadline dates in order to be reviewed at the next scheduled PRMC meeting. Deadlines may vary depending upon whether PRMC Office assistance with document preparation is requested.
In accordance with the implementation of the On-line Collaborative Research Environment (OnCore), protocol registration is required before submitting to PRMC and/or IRB. Currently, protocols are entered by the OnCore Staff. To request protocol registration by the OnCore staff, please complete the “OnCore Protocol Registration” form.
Each protocol reviewed and approved by the PRMC must be reviewed annually by the committee. The annual review notification will be sent to the principal investigator/study coordinator approximately one month before the due date by the PRMC Coordinator via email. The PRMC Coordinator will facilitate the completion of the annual review routing sheet and submission of the annual review to OnCore.