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 #
5P30CA068485-18
Application #
8733553
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2014-09-01
Budget End
2015-08-31
Support Year
18
Fiscal Year
2014
Total Cost
$164,107
Indirect Cost
$89,303

  Institution

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

  Publications

West, Kathryn L; Kelm, Nathaniel D; Carson, Robert P et al. (2018) Myelin volume fraction imaging with MRI. Neuroimage 182:511-521
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
Rohrbough, Jeffrey; Nguyen, Hong-Ngan; Lamb, Fred S (2018) Modulation of ClC-3 gating and proton/anion exchange by internal and external protons and the anion selectivity filter. J Physiol 596:4091-4119
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 :
Zhao, Shilin; Jing, Wang; Samuels, David C et al. (2018) Strategies for processing and quality control of Illumina genotyping arrays. Brief Bioinform 19:765-775
Goff, Laura W; Azad, Nilofer S; Stein, Stacey et al. (2018) Phase I study combining the aurora kinase a inhibitor alisertib with mFOLFOX in gastrointestinal cancer. Invest New Drugs :
Payton, Rebecca R; Rispoli, Louisa A; Nagle, Kimberly A et al. (2018) Mitochondrial-related consequences of heat stress exposure during bovine oocyte maturation persist in early embryo development. J Reprod Dev 64:243-251
Kovtun, Oleg; Tomlinson, Ian D; Bailey, Danielle M et al. (2018) Single Quantum Dot Tracking Illuminates Neuroscience at the Nanoscale. Chem Phys Lett 706:741-752
Schlegel, Cameron; Lapierre, Lynne A; Weis, Victoria G et al. (2018) Reversible deficits in apical transporter trafficking associated with deficiency in diacylglycerol acyltransferase. Traffic 19:879-892

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