The Cancer Clinical Trials Office (CCTO) provides oversight and quality control for University of Chicago Cancer Research Center's (UCCRC) clinical trials activity by centralizing regulatory and reporting functions through the provision of policies and procedures, supervision of staff, auditing, and a centralized database for tracking of these activities. The overall objective of the CCTO is to provide the infrastructure to support successful clinical research across departments. The office interacts with the Biostatistical Core facility, the Protocol Review and Monitoring System (PRMS), and the informatics subunit of the UCCRC. The services provided by the CCTO can be broadly categorized under the following key functions: 1) Regulatory Affairs: Centralized regulatory management for the conduct of all cancer clinical trials at the University of Chicago regardless of sponsor, department, or type of study. These services include completion of required forms and submission to the Clinical Trials Review Committee (CTRC), the Institutional Review Board (IRB), and other required committees (e.g., Institutional Biosafety Committee);annual renewals to the IRB and the Scientific and Accrual Monitoring Committee (SAM) of the UCCRC, and IND submissions. 2) Affiliate Institution Coordination and Oversight: Infrastructure for the participation of affiliate institutions enrolling patients on trials at the UCCRC, including 8 CALGB affiliate institutions, 15 Phase II NCI contract affiliate institutions, and over 15 additional ad hoc affiliates participating in selected studies. The CCTO coordinates all study-related communications, serves as the point of patient registration for some programs, and reviews operations to ensure compliance with federal regulations. 3) Protocol Tracking, Management: Centralized location and database (Velos eResearch) for tracking protocol-specific data, including study teams, protocol status, and patient registration;provides web based direct access (e.g., in clinics) to current consent forms, protocols, and investigational brochures;and report generation with respect to both clinical data and study status information. 4) Quality Control: Training of regulatory managers across departments, continuing education, support to nurses, data managers, faculty and fellows in the use of Velos eResearch, oversight of designated data and safety monitoring activities (e.g., SAE tracking, coordination of High-Risk Protocol Conference HRPC), coordination of the audit program, and development and implementation of Standard Operating Procedures (SOPs).

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
3P30CA014599-38S1
Application #
8744808
Study Section
Subcommittee G - Education (NCI)
Project Start
2013-09-30
Project End
2018-03-31
Budget Start
2013-09-30
Budget End
2014-03-31
Support Year
38
Fiscal Year
2013
Total Cost
$37,500
Indirect Cost
$13,766
Name
University of Chicago
Department
Type
DUNS #
005421136
City
Chicago
State
IL
Country
United States
Zip Code
60637
Drazer, Michael W; Stadler, Walter M (2016) The Role of Testosterone in the Treatment of Castration-Resistant Prostate Cancer. Cancer J 22:330-333
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
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 :
Epel, Boris; Redler, Gage; Pelizzari, Charles et al. (2016) Approaching Oxygen-Guided Intensity-Modulated Radiation Therapy. Adv Exp Med Biol 876:185-93
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