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 #
5P30CA046934-26
Application #
8616651
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-02-01
Budget End
2015-01-31
Support Year
26
Fiscal Year
2014
Total Cost
$60,711
Indirect Cost
$22,136

  Institution

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

  Publications

Greer, Robert O; Eskendri, Jeffrey; Freedman, Paul et al. (2018) Assessment of biologically aggressive, recurrent glandular odontogenic cysts for mastermind-like 2 (MAML2) rearrangements: histopathologic and fluorescent in situ hybridization (FISH) findings in 11 cases. J Oral Pathol Med 47:192-197
Tippimanchai, Darinee D; Nolan, Kyle; Poczobutt, Joanna et al. (2018) Adenoviral vectors transduce alveolar macrophages in lung cancer models. Oncoimmunology 7:e1438105
Ravindran Menon, Dinoop; Luo, Yuchun; Arcaroli, John J et al. (2018) CDK1 Interacts with Sox2 and Promotes Tumor Initiation in Human Melanoma. Cancer Res 78:6561-6574
Genova, Carlo; Socinski, Mark A; Hozak, Rebecca R et al. (2018) EGFR Gene Copy Number by FISH May Predict Outcome of Necitumumab in Squamous Lung Carcinomas: Analysis from the SQUIRE Study. J Thorac Oncol 13:228-236
Galati, Domenico F; Sullivan, Kelly D; Pham, Andrew T et al. (2018) Trisomy 21 Represses Cilia Formation and Function. Dev Cell 46:641-650.e6
Gavin, Kathleen M; Sullivan, Timothy M; Kohrt, Wendy M et al. (2018) Ovarian Hormones Regulate the Production of Adipocytes From Bone Marrow-Derived Cells. Front Endocrinol (Lausanne) 9:276
Nichols, Parker J; Henen, Morkos A; Born, Alexandra et al. (2018) High-resolution small RNA structures from exact nuclear Overhauser enhancement measurements without additional restraints. Commun Biol 1:61
Libby, Andrew E; Bales, Elise S; Monks, Jenifer et al. (2018) Perilipin-2 deletion promotes carbohydrate-mediated browning of white adipose tissue at ambient temperature. J Lipid Res 59:1482-1500
Hintzsche, Jennifer D; Yoo, Minjae; Kim, Jihye et al. (2018) IMPACT web portal: oncology database integrating molecular profiles with actionable therapeutics. BMC Med Genomics 11:26
Cao, Shengya; Zhou, Keda; Zhang, Zhening et al. (2018) Constitutive centromere-associated network contacts confer differential stability on CENP-A nucleosomes in vitro and in the cell. Mol Biol Cell 29:751-762

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