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

Pleiman, Jennifer K; Irving, Amy A; Wang, Zhishi et al. (2018) The conserved protective cyclic AMP-phosphodiesterase function PDE4B is expressed in the adenoma and adjacent normal colonic epithelium of mammals and silenced in colorectal cancer. PLoS Genet 14:e1007611
Kletzien, Heidi; Macdonald, Cameron L; Orne, Jason et al. (2018) Comparison Between Patient-Perceived Voice Changes and Quantitative Voice Measures in the First Postoperative Year After Thyroidectomy: A Secondary Analysis of a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg 144:995-1003
Kang, Lei; Jiang, Dawei; Ehlerding, Emily B et al. (2018) Noninvasive Trafficking of Brentuximab Vedotin and PET Imaging of CD30 in Lung Cancer Murine Models. Mol Pharm 15:1627-1634
Bulu, Hakan; Sippo, Dorothy A; Lee, Janie M et al. (2018) Proposing New RadLex Terms by Analyzing Free-Text Mammography Reports. J Digit Imaging 31:596-603
Jewett, Patricia I; Gangnon, Ronald E; Elkin, Elena et al. (2018) Geographic access to mammography facilities and frequency of mammography screening. Ann Epidemiol 28:65-71.e2
Albertini, Mark R (2018) The age of enlightenment in melanoma immunotherapy. J Immunother Cancer 6:80
Shull, James D; Dennison, Kirsten L; Chack, Aaron C et al. (2018) Rat models of 17?-estradiol-induced mammary cancer reveal novel insights into breast cancer etiology and prevention. Physiol Genomics 50:215-234
Kang, Lei; Jiang, Dawei; England, Christopher G et al. (2018) ImmunoPET imaging of CD38 in murine lymphoma models using 89Zr-labeled daratumumab. Eur J Nucl Med Mol Imaging 45:1372-1381
Melgar-Asensio, Ignacio; Kandela, Irawati; Aird, Fraser et al. (2018) Extended Intravitreal Rabbit Eye Residence of Nanoparticles Conjugated With Cationic Arginine Peptides for Intraocular Drug Delivery: In Vivo Imaging. Invest Ophthalmol Vis Sci 59:4071-4081
Jang, Samuel; Rosenberg, Stephen A; Hullet, Craig et al. (2018) Value of Elective Radiation Oncology Rotations: How Many Is Too Many? Int J Radiat Oncol Biol Phys 100:558-559

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