The purpose of the Protocol Review and Monitoring System (PRMS) is to review the scientific merit, scientific priorities, and scientific progress of cancer-related studies that are conducted at the University of Chicago, regardless of sponsor, department or type, and that use the University of Chicago Comprehensive Cancer Center (UCCCC) resources. The UCCCC PRMS is divided into two committees, the Clinical Trials Review Committee (CTRC), and the Scientific and Accrual Monitoring (SAM) Committee, which are overseen by the Associate Director for Clinical Sciences (Dr. Mark Ratain) and the Clinical Research Advisory Committee (CRAC). A single Coordinator serves all three committees. The CTRC and SAM are composed of UCCCC members from all academic units and disciplines who have expertise in clinical trials. The CTRC meets monthly, and has primary responsibility for evaluation of the scientific merit, rigor, appropriateness of data and safety monitoring, and the relative prioritization of trials in the context of UCCCC and disease-specific program goals and resources. CTRC and IRB review occur simultaneously, but protocol activation requires full CTRC approval. CTRC reviews are conducted by at least 3 individuals, including a biostatistician. Protocols may be approved, approved with revisions, deferred, or disapproved. Protocols that have undergone prior peer review (e.g., cooperative group protocols, NIH, ACS) and strict banking/registry studies are eligible for expedited review;that is, they are not required to be reviewed by the full committee, but rather will be reviewed by the Chair or Co-chair who have the option of bringing them to the full committee if there are specific concerns (e.g., design, prioritization). In addition, CTRC has the authority to close protocols based on the recommendation of the SAM Committee. Specifically, the SAM Committee has primary responsibility for monitoring the scientific progress of CTRC-approved studies including accrual, minority accrual, and overall progress towards meeting the study's objectives, as well as ensuring adherence to protocol procedures and UCCCC Data and Safety Monitoring requirements. The SAM Committee meets monthly, and recommends closure of protocols that are not making adequate scientific progress, or that are not meeting adequate scientific or Data and Safety Monitoring guidelines.

Public Health Relevance

The PRMS serves an important role In the UCCCC's clinical research infrastructure. Through initial and ongoing review of cancer-related trials, the PRMS ensures that all cancer-related studies conducted at the UCCCC are scientifically sound, are conducted according to ethical standards, have appropriate data and safety monitoring and use institutional resources appropriately.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Chicago
United States
Zip Code
Sharifi, Marina N; Mowers, Erin E; Drake, Lauren E et al. (2016) Autophagy Promotes Focal Adhesion Disassembly and Cell Motility of Metastatic Tumor Cells through the Direct Interaction of Paxillin with LC3. Cell Rep 15:1660-72
Drazer, Michael W; Stadler, Walter M (2016) The Role of Testosterone in the Treatment of Castration-Resistant Prostate Cancer. Cancer J 22:330-333
Epel, Boris; Redler, Gage; Pelizzari, Charles et al. (2016) Approaching Oxygen-Guided Intensity-Modulated Radiation Therapy. Adv Exp Med Biol 876:185-93
Sweis, Randy F; Medved, Milica; Towey, Shannon et al. (2016) Dynamic Contrast-Enhanced Magnetic Resonance Imaging as a Pharmacodynamic Biomarker for Pazopanib in Metastatic Renal Carcinoma. Clin Genitourin Cancer :
Volden, Paul A; Skor, Maxwell N; Johnson, Marianna B et al. (2016) Mammary Adipose Tissue-Derived Lysophospholipids Promote Estrogen Receptor-Negative Mammary Epithelial Cell Proliferation. Cancer Prev Res (Phila) 9:367-78
Stein, Michelle M; Hrusch, Cara L; Gozdz, Justyna et al. (2016) Innate Immunity and Asthma Risk in Amish and Hutterite Farm Children. N Engl J Med 375:411-21
Baron, Beverly W; Baron, Rebecca M; Baron, Joseph M (2016) The Relationship between RUVBL1 (Pontin, TIP49, NMP238) and BCL6 in Benign and Malignant Human Lymphoid Tissues. Biochem Biophys Rep 6:1-8
King, Andrea C; Hasin, Deborah; O'Connor, Sean J et al. (2016) A Prospective 5-Year Re-examination of Alcohol Response in Heavy Drinkers Progressing in Alcohol Use Disorder. Biol Psychiatry 79:489-98
Appelbe, Oliver K; Zhang, Qingbei; Pelizzari, Charles A et al. (2016) Image-Guided Radiotherapy Targets Macromolecules through Altering the Tumor Microenvironment. Mol Pharm 13:3457-3467
Morrison, Gladys; Lenkala, Divya; LaCroix, Bonnie et al. (2016) Utility of patient-derived lymphoblastoid cell lines as an ex vivo capecitabine sensitivity prediction model for breast cancer patients. Oncotarget 7:38359-38366

Showing the most recent 10 out of 534 publications