7.0 Protocol Review and Monitoring System (PRMS) Description The Cancer Protocol Review Committee (CPRC) functions as the Protocol Review and Monitoring System for the Masonic Cancer Center (MCC). The MCC Clinical Research Leadership (CRL) appoints the chair of the CPRC. Committee members may be selected by the CRL or the CPRC chair. Members are selected by area of expertise to form a diversified group of clinicians and other professionals able to provide rigorous scientific review of study rationale and design. The CPRC membership is divided into 2 subcommittees: the Therapeutic Interventional Committee, which meets twice monthly, and the Non-Therapeutic Interventional Committee, which meets monthly. The MCC Clinical Trials Office provides administrative support to both CPRC subcommittees. Protocol prioritization has been emphasized during the last granting period to ensure greater efficiency of clinical trial management and to optimize patient enrollment. Prior to CPRC review, protocols or protocol concepts are sent to the appropriate interdisciplinary site-specific cancer care (ISC) team for review. The purpose of the ISC teams is to identify the needs of the patients they see;identify appropriate clinical trials to address these needs from industry. Cooperative Group, and investigator-initiated resources;and prioritize enrollment of patients in clinical trials. The CPRC reviews each study with regard to the following criteria, and can approve, approve with stipulations, defer, or disapprove each study: * Purpose of study * Justification of study, including results of previous studies or pilot data * Inclusion/exclusion requirements * Treatment plan, including doses, dose adjustments, schedule, and duration * Description of all drugs, including chemical formula when available, known toxicities, methods of procurement, methods of storage, and other relevant information * Adequacy of the data and safety monitoring plan * Biostatistical support (investigator-initiated trials only) * Adequacy of the statistical section Time to protocol approval continues to be monitored with the aim of expediting clinical trial implementation. Ongoing post-approval review includes review of amendments, annual review, and accrual reviews.

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 Minnesota Twin Cities
United States
Zip Code
Lin, Lifeng; Chu, Haitao; Murad, Mohammad Hassan et al. (2018) Empirical Comparison of Publication Bias Tests in Meta-Analysis. J Gen Intern Med 33:1260-1267
Rashidi, Armin; Ebadi, Maryam; Said, Bassil et al. (2018) Absence of early HHV-6 reactivation after cord blood allograft predicts powerful graft-versus-tumor effect. Am J Hematol :
Bejanyan, Nelli; Brunstein, Claudio G; Cao, Qing et al. (2018) Delayed immune reconstitution after allogeneic transplantation increases the risks of mortality and chronic GVHD. Blood Adv 2:909-922
Bachanova, Veronika; Sarhan, Dhifaf; DeFor, Todd E et al. (2018) Haploidentical natural killer cells induce remissions in non-Hodgkin lymphoma patients with low levels of immune-suppressor cells. Cancer Immunol Immunother 67:483-494
Hupp, Meghan; Williams, Sarah; Dunnette, Brian et al. (2018) Comparison of evaluation techniques, including digital image analysis, for MYC protein expression by immunohistochemical stain in aggressive B-cell lymphomas. Hum Pathol :
Rashidi, Armin; Shanley, Ryan; Holtan, Shernan G et al. (2018) Pretransplant Serum Citrulline Predicts Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant 24:2190-2196
Ma, Bin; Zarth, Adam T; Carlson, Erik S et al. (2018) Methyl DNA Phosphate Adduct Formation in Rats Treated Chronically with 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone and Enantiomers of Its Metabolite 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol. Chem Res Toxicol 31:48-57
Hatsukami, Dorothy K; Luo, Xianghua; Jensen, Joni A et al. (2018) Effect of Immediate vs Gradual Reduction in Nicotine Content of Cigarettes on Biomarkers of Smoke Exposure: A Randomized Clinical Trial. JAMA 320:880-891
Lee, Hak Rae; Leslie, Faith; Azarin, Samira M (2018) A facile in vitro platform to study cancer cell dormancy under hypoxic microenvironments using CoCl2. J Biol Eng 12:12
Yang, Libang; Herrera, Jeremy; Gilbertsen, Adam et al. (2018) IL-8 mediates idiopathic pulmonary fibrosis mesenchymal progenitor cell fibrogenicity. Am J Physiol Lung Cell Mol Physiol 314:L127-L136

Showing the most recent 10 out of 1013 publications