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

Pannala, Venkat R; Wall, Martha L; Estes, Shanea K et al. (2018) Metabolic network-based predictions of toxicant-induced metabolite changes in the laboratory rat. Sci Rep 8:11678
Zhao, Shilin; Li, Chung-I; Guo, Yan et al. (2018) RnaSeqSampleSize: real data based sample size estimation for RNA sequencing. BMC Bioinformatics 19:191
Croessmann, Sarah; Sheehan, Jonathan H; Lee, Kyung-Min et al. (2018) PIK3CA C2 Domain Deletions Hyperactivate Phosphoinositide 3-kinase (PI3K), Generate Oncogene Dependence, and Are Exquisitely Sensitive to PI3K? Inhibitors. Clin Cancer Res 24:1426-1435
Doxie, Deon B; Greenplate, Allison R; Gandelman, Jocelyn S et al. (2018) BRAF and MEK inhibitor therapy eliminates Nestin-expressing melanoma cells in human tumors. Pigment Cell Melanoma Res 31:708-719
Salisbury-Ruf, Christi T; Bertram, Clinton C; Vergeade, Aurelia et al. (2018) Bid maintains mitochondrial cristae structure and function and protects against cardiac disease in an integrative genomics study. Elife 7:
Laroumanie, Fanny; Korneva, Arina; Bersi, Matthew R et al. (2018) LNK deficiency promotes acute aortic dissection and rupture. JCI Insight 3:
Burns, Michael C; Howes, Jennifer E; Sun, Qi et al. (2018) High-throughput screening identifies small molecules that bind to the RAS:SOS:RAS complex and perturb RAS signaling. Anal Biochem 548:44-52
Phelps, Hannah M; Al-Jadiry, Mazin F; Corbitt, Natasha M et al. (2018) Molecular and epidemiologic characterization of Wilms tumor from Baghdad, Iraq. World J Pediatr 14:585-593
Liu, Qi; Herring, Charles A; Sheng, Quanhu et al. (2018) Quantitative assessment of cell population diversity in single-cell landscapes. PLoS Biol 16:e2006687
Almodovar, Karinna; Iams, Wade T; Meador, Catherine B et al. (2018) Longitudinal Cell-Free DNA Analysis in Patients with Small Cell Lung Cancer Reveals Dynamic Insights into Treatment Efficacy and Disease Relapse. J Thorac Oncol 13:112-123

Showing the most recent 10 out of 2462 publications