Abstract

The Data and Safety Monitoring System.(DSMS) 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. 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 ONCORE database which allows more efficient tracking of protocols and protocol subjects. The DSMC reviews reports on quality assurance (internal audits, response reviews), protocol deviations and severe 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 the UWCCC. The DSMC is chaired and co-chaired by James Stewart, Professor of Medicine, and KyungMann Kim, Professor of Biostatistics and Medical Informatics, each with >20 years of clinical trials experience.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA014520-38
Application #
8250424
Study Section
Subcommittee G - Education (NCI)
Project Start
2011-04-01
Project End
2013-03-31
Budget Start
2011-04-01
Budget End
2012-03-31
Support Year
38
Fiscal Year
2011
Total Cost
$124,149
Indirect Cost

  Institution

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

  Publications

Bednarz, Bryan; Grudzinski, Joseph; Marsh, Ian et al. (2018) Murine-specific Internal Dosimetry for Preclinical Investigations of Imaging and Therapeutic Agents. Health Phys 114:450-459
Romero-Masters, James C; Ohashi, Makoto; Djavadian, Reza et al. (2018) An EBNA3C-deleted Epstein-Barr virus (EBV) mutant causes B-cell lymphomas with delayed onset in a cord blood-humanized mouse model. PLoS Pathog 14:e1007221
Xu, Cheng; Chen, Feng; Valdovinos, Hector F et al. (2018) Bacteria-like mesoporous silica-coated gold nanorods for positron emission tomography and photoacoustic imaging-guided chemo-photothermal combined therapy. Biomaterials 165:56-65
Wargowski, Ellen; Johnson, Laura E; Eickhoff, Jens C et al. (2018) Prime-boost vaccination targeting prostatic acid phosphatase (PAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) using Sipuleucel-T and a DNA vaccine. J Immunother Cancer 6:21
Schrager, Sarina; Burnside, Elizabeth (2018) Breast Cancer Screening in Primary Care: A Call for Development and Validation of Patient-Oriented Shared Decision-Making Tools. J Womens Health (Larchmt) :
van den Broek, Jeroen J; van Ravesteyn, Nicolien T; Mandelblatt, Jeanne S et al. (2018) Comparing CISNET Breast Cancer Incidence and Mortality Predictions to Observed Clinical Trial Results of Mammography Screening from Ages 40 to 49. Med Decis Making 38:140S-150S
Lu, Zhanping; Hong, Courtney C; Kong, Guangyao et al. (2018) Polycomb Group Protein YY1 Is an Essential Regulator of Hematopoietic Stem Cell Quiescence. Cell Rep 22:1545-1559
Shea, Michael P; O'Leary, Kathleen A; Fakhraldeen, Saja A et al. (2018) Antiestrogen Therapy Increases Plasticity and Cancer Stemness of Prolactin-Induced ER?+ Mammary Carcinomas. Cancer Res 78:1672-1684
Carroll, Molly J; Fogg, Kaitlin C; Patel, Harin A et al. (2018) Alternatively-Activated Macrophages Upregulate Mesothelial Expression of P-Selectin to Enhance Adhesion of Ovarian Cancer Cells. Cancer Res 78:3560-3573
Ehlerding, Emily B; Grodzinski, Piotr; Cai, Weibo et al. (2018) Big Potential from Small Agents: Nanoparticles for Imaging-Based Companion Diagnostics. ACS Nano 12:2106-2121

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