The Clinical Protocol Scientific Review and Monitoring System (PRMS) was fully approved by the NIH/NCI on December 16, 1996. The PRMS provides an initial review for scientific merit and feasibility for every protocol not sponsored by an NCI-sponsored national cooperative group. The PRMS also reviews protocol-specific data and safety monitoring plans and revisions of previously approved investigator-initiated protocols. The PRMS does not provide an auditing or monitoring function, but receives reports from the Data and Safety Monitoring Committee (DSMC) as well as any active independent Data and Safety Monitoring Boards (DSMBs). In order to facilitate cooperation and share information, the PRMS sends minutes to the IRB and receives both the IRB agenda and IRB minutes. This exchange allows the PRMS to monitor submissions to the IRB to ensure that appropriate protocols that have not received PRMS approval are not reviewed by the IRB. The PRMS coordinator also queries the IRB's database monthly to track protocol progress and ensure current data. The System is coordinated by a full time Program Coordinator, currently supported 50% by the CCSG. Because the review requirements and database support have increased since the last renewal, we request an increase to 80% salary support for Catherine Reniere (Program Coordinator) and continued support at 10% for James Larner, MD (PRMS Chair), as well as the $1,000 for supplies.
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