Abstract

Purpose The Vanderbilt-lngram Cancer Center (VICC) oversees patient safety and data monitoring for its investigator-initiated and NIH-NCl funded clinical trials through its Data and Safety Monitoring Committee (DSMC). The purpose of the DSMC is to ensure the efficient implementation and management of the VICC Data and Safety Monitoring Plan (DSMP). The Committee maintains authority to intervene in the conduct of studies as necessary to ensure clinical research performed at VICC achieves the highest quality standards. Data and Safety Monitoring Plan The DSMP is accessible to all VICC investigators through the VICC website. The plan scope addresses the following: ? Proper monitoring of trial progress and the safety of clinical trial participants ? Compliance with requirements regarding the reporting of adverse events as per institutional and federal guidelines ? Scope of temporary or permanent suspension of an NCI-funded clinical trial ? Data accuracy and protocol compliance VICC's plan is approved by the NCI Data and Safety Monitoring Review Panel as well as the Vanderbilt University Medical Center Institutional Review Board.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA068485-17
Application #
8545040
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-09-01
Budget End
2014-08-31
Support Year
17
Fiscal Year
2013
Total Cost
$157,118
Indirect Cost
$86,081

  Institution

Name
Vanderbilt University Medical Center
Department
Type
DUNS #
004413456
City
Nashville
State
TN
Country
United States
Zip Code
37212

  Publications

Yang, Jinming; Kumar, Amrendra; Vilgelm, Anna E et al. (2018) Loss of CXCR4 in Myeloid Cells Enhances Antitumor Immunity and Reduces Melanoma Growth through NK Cell and FASL Mechanisms. Cancer Immunol Res 6:1186-1198
Alvarado, Gabriela; Ettayebi, Khalil; Atmar, Robert L et al. (2018) Human Monoclonal Antibodies That Neutralize Pandemic GII.4 Noroviruses. Gastroenterology 155:1898-1907
Cardin, Dana B; Goff, Laura W; Chan, Emily et al. (2018) Dual Src and EGFR inhibition in combination with gemcitabine in advanced pancreatic cancer: phase I results : A phase I clinical trial. Invest New Drugs 36:442-450
Guo, Xingyi; Lin, Weiqiang; Bao, Jiandong et al. (2018) A Comprehensive cis-eQTL Analysis Revealed Target Genes in Breast Cancer Susceptibility Loci Identified in Genome-wide Association Studies. Am J Hum Genet 102:890-903
Garcia, A Denise R; Han, Young-Goo; Triplett, Jason W et al. (2018) The Elegance of Sonic Hedgehog: Emerging Novel Functions for a Classic Morphogen. J Neurosci 38:9338-9345
Sierra, Johanna C; Asim, Mohammad; Verriere, Thomas G et al. (2018) Epidermal growth factor receptor inhibition downregulates Helicobacter pylori-induced epithelial inflammatory responses, DNA damage and gastric carcinogenesis. Gut 67:1247-1260
Lu, Sichang; McGough, Madison A P; Shiels, Stefanie M et al. (2018) Settable polymer/ceramic composite bone grafts stabilize weight-bearing tibial plateau slot defects and integrate with host bone in an ovine model. Biomaterials 179:29-45
Santos Guasch, Gabriela L; Beeler, J Scott; Marshall, Clayton B et al. (2018) p73 Is Required for Ovarian Follicle Development and Regulates a Gene Network Involved in Cell-to-Cell Adhesion. iScience 8:236-249
West, Kathryn L; Kelm, Nathaniel D; Carson, Robert P et al. (2018) Myelin volume fraction imaging with MRI. Neuroimage 182:511-521
May-Zhang, Aaron A; Deal, Karen K; Southard-Smith, E Michelle (2018) Optimization of Laser-Capture Microdissection for the Isolation of Enteric Ganglia from Fresh-Frozen Human Tissue. J Vis Exp :

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