Abstract

Objective: The overall purpose of QA DSM Shared Resource is to insure the highest quality, safest, most precisely performed clinical cancer research at the UCCC. Structure and services: The overall goal of QA and DSM for the University of Colorado Cancer Center (UCCC) remains twofold: 1) insure the safety and ethical treatment of all human subjects participating in research;2) verify the accuracy, completeness, validity and integrity of all data_collected. Multiple committees and processes contribute to the achievement of these goals. UCCC Protocol Quality Assurance and Safety Committee (PQASC) oversees all aspects of the process within the UCCC Clinical Investigations Core Shared Resource (CICSR) and reports to the Executive Committee of the UCCC, and to COMIRB;and oversees reporting of AEs and SAEs to sponsors and federal agencies, e.g., NCI AdEERs. Collaborative efforts to improve the efficiency and accuracy of the clinical trials process at UC Anschutz Medical Campus (AMC) and UCCC continue through UCCC CICSR interactions with COMIRB including the Director of COMIRB (Alison Lakin, RN, PhD), the Associate Vice Chancellor for Compliance (Angela Wishon, JD) and other groups such as the School of Medicine Clinical Trials Research Advisory Committee (CTRAC) and importantly the protocol review and monitoring committee (PRMC) of the UCCC. These collaborations have contributed to the successful CTSA application in 2008 (Colorado Clinical Translational Sciences Institute). The CICSR Education Committee identifies develops and offers a variety of instructional activities to improve the l The aims of the education activities are to insure high quality conduct and analysis of clinical trials and the specific objectives remain as presented in the Competing Renewal. Four subcommittees provide the needed training: oversight continuing education, orientation and competency Utilization: All UCCC human subject research is subject to oversight by this core. Audits of selected trials, especially investigator-Initiated, are conducted periodically, and the PQASC of this core also provides a data safety monitoring board (DSMB) for trials which do not have a designated DSMB.

Public Health Relevance

At the University of Colorado Cancer Center (UCCC) we take patient research (clinical trials) safety very seriously. We have specific body called the Quality Assurance (QA) / Data Safety Monitoring (DSM)for this purpose. The mission of QA DSM Shared Resource is to insure the highest quality, safest, most precisely performed clinical cancer research at the UCCC grant applications or industry.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA046934-25
Application #
8567547
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-02-01
Budget End
2014-01-31
Support Year
25
Fiscal Year
2013
Total Cost
$102,482
Indirect Cost
$33,644

  Institution

Name
University of Colorado Denver
Department
Type
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045

  Publications

New, Melissa L; White, Collin M; McGonigle, Polly et al. (2018) Prostacyclin and EMT Pathway Markers for Monitoring Response to Lung Cancer Chemoprevention. Cancer Prev Res (Phila) 11:643-654
Vartuli, Rebecca L; Zhou, Hengbo; Zhang, Lingdi et al. (2018) Eya3 promotes breast tumor-associated immune suppression via threonine phosphatase-mediated PD-L1 upregulation. J Clin Invest 128:2535-2550
Scott, Aaron J; Arcaroli, John J; Bagby, Stacey M et al. (2018) Cabozantinib Exhibits Potent Antitumor Activity in Colorectal Cancer Patient-Derived Tumor Xenograft Models via Autophagy and Signaling Mechanisms. Mol Cancer Ther 17:2112-2122
da Silva, Raquel Frenedoso; Dhar, Deepanshi; Raina, Komal et al. (2018) Nintedanib inhibits growth of human prostate carcinoma cells by modulating both cell cycle and angiogenesis regulators. Sci Rep 8:9540
Majtan, Tomas; Jones Jr, Wendell; Krijt, Jakub et al. (2018) Enzyme Replacement Therapy Ameliorates Multiple Symptoms of Murine Homocystinuria. Mol Ther 26:834-844
Dhar, Deepanshi; Deep, Gagan; Kumar, Sushil et al. (2018) Bitter melon juice exerts its efficacy against pancreatic cancer via targeting both bulk and cancer stem cells. Mol Carcinog 57:1166-1180
Donson, Andrew M; Amani, Vladimir; Warner, Elliot A et al. (2018) Identification of FDA-Approved Oncology Drugs with Selective Potency in High-Risk Childhood Ependymoma. Mol Cancer Ther 17:1984-1994
Branchford, B R; Stalker, T J; Law, L et al. (2018) The small-molecule MERTK inhibitor UNC2025 decreases platelet activation and prevents thrombosis. J Thromb Haemost 16:352-363
Pei, Shanshan; Minhajuddin, Mohammad; Adane, Biniam et al. (2018) AMPK/FIS1-Mediated Mitophagy Is Required for Self-Renewal of Human AML Stem Cells. Cell Stem Cell 23:86-100.e6
Ren, Shengxiang; Rivard, Christopher J; Yu, Hui et al. (2018) A miRNA Panel Predicts Sensitivity of FGFR Inhibitor in Lung Cancer Cell Lines. Clin Lung Cancer 19:450-456

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