Abstract

The Data and Safety Monitoring System (DSMS) of UW Carbone Cancer Center (UWCCC) ensures that all clinical research being conducted under the auspices of UWCCC is in compliance with federal requirements and most importantly that human subject safety is always optimized. The DSMS is assisted in its mission of safety and compliance by experienced UWCCC research staff, a Data and Safety Monitoring Committee (DSMC) composed of experienced clinical researchers, and the ongoing use of the Clinical Research Management System (CRMS), OnCore by Forte Research Systems, which allows efficient tracking of protocols and protocol subjects. The DSMC reviews reports on quality assurance (internal audits, quality assurance reviews, response reviews, protocol summary reports, and compliance reviews), protocol deviations/non-compliance, and serious adverse events. The DSMC also provides data review, data abstraction and entry, forms monitoring and final report generation for studies developed and solely monitored by UWCCC. The DSMC is chaired by Anne Traynor, M.D., Associate Professor of Medicine, and co-chaired by KyungMann Kim, Ph.D., Professor of Biostatistics and Medical Informatics, each with over 15 years of clinical trials experience.

Public Health Relevance

The Data and Safety Monitoring System of the UWCCC ensures that all clinical research being conducted under the auspices of the UWCCC is in compliance with federal requirements and most importantly that human subject safety is always optimized.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA014520-39
Application #
8483771
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-04-25
Project End
2018-03-31
Budget Start
2013-04-12
Budget End
2014-03-31
Support Year
39
Fiscal Year
2013
Total Cost
$182,929
Indirect Cost
$66,047

  Institution

Name
University of Wisconsin Madison
Department
Type
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715

  Publications

Zahm, Christopher D; Colluru, Viswa T; McIlwain, Sean J et al. (2018) TLR Stimulation during T-cell Activation Lowers PD-1 Expression on CD8+ T Cells. Cancer Immunol Res 6:1364-1374
Chen, Feng; Goel, Shreya; Shi, Sixiang et al. (2018) General synthesis of silica-based yolk/shell hybrid nanomaterials and in vivo tumor vasculature targeting. Nano Res 11:4890-4904
Erbe, Amy K; Wang, Wei; Carmichael, Lakeesha et al. (2018) Neuroblastoma Patients' KIR and KIR-Ligand Genotypes Influence Clinical Outcome for Dinutuximab-based Immunotherapy: A Report from the Children's Oncology Group. Clin Cancer Res 24:189-196
Eckers, Jaimee C; Swick, Adam D; Kimple, Randall J (2018) Identity Crisis - Rigor and Reproducibility in Human Cell Lines. Radiat Res 189:551-552
O'Driscoll, Chelsea A; Owens, Leah A; Gallo, Madeline E et al. (2018) Differential effects of diesel exhaust particles on T cell differentiation and autoimmune disease. Part Fibre Toxicol 15:35
Fleszar, Andrew J; Walker, Alyssa; Porubsky, Veronica et al. (2018) The Extracellular Matrix of Ovarian Cortical Inclusion Cysts Modulates Invasion of Fallopian Tube Epithelial Cells. APL Bioeng 2:
Tucholka, Jennifer L; Yang, Dou-Yan; Bruce, Jordan G et al. (2018) A Randomized Controlled Trial Evaluating the Impact of Web-Based Information on Breast Cancer Patients' Knowledge of Surgical Treatment Options. J Am Coll Surg 226:126-133
Schwei, Rebecca J; Schroeder, Michelle; Ejebe, Ifna et al. (2018) Limited English Proficient Patients' Perceptions of when Interpreters are Needed and how the Decision to Utilize Interpreters is Made. Health Commun 33:1503-1508
Nyman, Patrick E; Buehler, Darya; Lambert, Paul F (2018) Loss of Function of Canonical Notch Signaling Drives Head and Neck Carcinogenesis. Clin Cancer Res 24:6308-6318
Barault, Ludovic; Amatu, Alessio; Siravegna, Giulia et al. (2018) Discovery of methylated circulating DNA biomarkers for comprehensive non-invasive monitoring of treatment response in metastatic colorectal cancer. Gut 67:1995-2005

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