# Protocol Review and Monitoring System > **NIH NIH P30** · UNIVERSITY OF COLORADO DENVER · 2024 · $33,814 ## Abstract ABSTRACT The Protocol Review and Monitoring System (PRMS) of the University of Colorado Cancer Center (UCCC) is an integral component of the clinical research performed at UCCC. PRMS functions for cancer clinical trials across the UCCC include: 1) review of scientific merit prior to submission to an Institutional Review Board (IRB); 2) assessment of study priority and feasibility, and 3) monitoring of intervention trials for accrual and scientific progress. The PRMS collaborates with, but operates independently of, the IRB and the UCCC Data and Safety Monitoring Committee (DSMC). The PRMS Chair reports directly to the UCCC Director. All clinical cancer research conducted within UCCC is reviewed to ensure the appropriate PRMS review type occurs and is captured accurately in the Clinical Trial Management System, OnCore®. New protocol submissions to PRMS are reviewed at appropriate levels based on the type of review and committee standard operating procedures. The PRMS is comprised of two committees, the PRMS-Scientific Review Committee (PRMS-SRC) and the PRMS-Executive Committee (PRMS-EC). Members of these committees reflect the breadth and diversity of disciplines and programs across the UCCC. The PRMS-SRC meets twice per month to evaluate the scientific merit of studies and provide a focused, well-documented, and timely scientific review of institutional and industry intervention protocols. PRMS-SRC membership includes the PRMS Chair, Deputy Chair, biostatisticians and a diverse group of 30 investigators from oncologic disciplines. In the prior three years, PRMS has reviewed and prioritized 528 intervention studies. 30% (156) were National Clinical Trial Network (NCTN) or external peer reviewed studies that received a feasibility and prioritization review only. The remaining 70% were institutional (89) and industry (283) studies. Of the interventional studies reviewed at full board, 19 of 376 (5%) were disapproved, 35 of 376 (9%) required modifications be made to the protocol prior to approval, and 75 of 376 protocols (20%) required clarifications prior to approval. PRMS reviews all amendments submitted for active protocols. The PRMS-EC meets quarterly and assesses the scientific progress of protocols. This group also creates the by-laws for how PRMS functions and approves all operational changes made to PRMS. PRMS-EC membership includes the PRMS Chair, Deputy Chair, and six senior investigators. Since July 2016, 36 studies were closed by PRMS for a lack of progress or closed voluntarily by the principal investigator (PI) following receipt of low-accrual letters from PRMS. During the next grant period, PRMS will continue to apply a careful evaluation of feasibility and prioritization to ensure UCCC investigators open studies that are scientifically meritorious, feasible, and meet the priorities of the UCCC. PRMS will support a continued emphasis on successful investigator-initiated trials across UCCC. PRMS is working w... ## Key facts - **NIH application ID:** 10838376 - **Project number:** 5P30CA046934-36 - **Recipient organization:** UNIVERSITY OF COLORADO DENVER - **Principal Investigator:** RICHARD D SCHULICK - **Activity code:** P30 (R01, R21, SBIR, etc.) - **Funding institute:** NIH - **Fiscal year:** 2024 - **Award amount:** $33,814 - **Award type:** 5 - **Project period:** 1997-04-04 → 2027-01-31 ## Primary source NIH RePORTER: https://reporter.nih.gov/project-details/10838376 ## Citation > US National Institutes of Health, RePORTER application 10838376, Protocol Review and Monitoring System (5P30CA046934-36). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10838376. Licensed CC0. --- *[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*