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 #
5P30CA014520-40
Application #
8762778
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-04-01
Budget End
2015-03-31
Support Year
40
Fiscal Year
2014
Total Cost
$164,635
Indirect Cost
$59,442

  Institution

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

  Publications

Lee, Cindy S; Sickles, Edward A; Burnside, Elizabeth S (2018) Data-Driven Mammography Screening Practices-Reply. JAMA Oncol 4:588-589
Djavadian, Reza; Hayes, Mitchell; Johannsen, Eric (2018) CAGE-seq analysis of Epstein-Barr virus lytic gene transcription: 3 kinetic classes from 2 mechanisms. PLoS Pathog 14:e1007114
Engle, Jeff A; Traynor, Anne M; Campbell, Toby C et al. (2018) Assessment of adherence and relative dose intensity with oral chemotherapy in oncology clinical trials at an academic medical center. J Oncol Pharm Pract 24:348-353
Cummings, Nicole E; Williams, Elizabeth M; Kasza, Ildiko et al. (2018) Restoration of metabolic health by decreased consumption of branched-chain amino acids. J Physiol 596:623-645
McDaniel, Nellie K; Cummings, Christopher T; Iida, Mari et al. (2018) MERTK Mediates Intrinsic and Adaptive Resistance to AXL-targeting Agents. Mol Cancer Ther 17:2297-2308
Tucholka, J L; Jacobson, N; Steffens, N M et al. (2018) Breast cancer survivor's perspectives on the role different providers play in follow-up care. Support Care Cancer 26:2015-2022
Mukaddim, Rashid Al; Rodgers, Allison; Hacker, Timothy A et al. (2018) Real-Time in Vivo Photoacoustic Imaging in the Assessment of Myocardial Dynamics in Murine Model of Myocardial Ischemia. Ultrasound Med Biol 44:2155-2164
Eslani, Medi; Putra, Ilham; Shen, Xiang et al. (2018) Cornea-Derived Mesenchymal Stromal Cells Therapeutically Modulate Macrophage Immunophenotype and Angiogenic Function. Stem Cells 36:775-784
Tanratana, Pansakorn; Ellery, Paul; Westmark, Pamela et al. (2018) Elevated Plasma Factor IXa Activity in Premenopausal Women on Hormonal Contraception. Arterioscler Thromb Vasc Biol 38:266-274
Mora-Pinzon, Maria C; Chrischilles, Elizabeth A; Greenlee, Robert T et al. (2018) Variation in coordination of care reported by breast cancer patients according to health literacy. Support Care Cancer :

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