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 #
8733551
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

Nyhoff, Lindsay E; Clark, Emily S; Barron, Bridgette L et al. (2018) Bruton's Tyrosine Kinase Is Not Essential for B Cell Survival beyond Early Developmental Stages. J Immunol 200:2352-2361
Horvat, Andela; Noto, Jennifer M; Ramatchandirin, Balamurugan et al. (2018) Helicobacter pylori pathogen regulates p14ARF tumor suppressor and autophagy in gastric epithelial cells. Oncogene 37:5054-5065
Funkhouser-Jones, Lisa J; van Opstal, Edward J; Sharma, Ananya et al. (2018) The Maternal Effect Gene Wds Controls Wolbachia Titer in Nasonia. Curr Biol 28:1692-1702.e6
Harris, Nicholas A; Isaac, Austin T; Günther, Anne et al. (2018) Dorsal BNST ?2A-Adrenergic Receptors Produce HCN-Dependent Excitatory Actions That Initiate Anxiogenic Behaviors. J Neurosci 38:8922-8942
Shropshire, J Dylan; On, Jungmin; Layton, Emily M et al. (2018) One prophage WO gene rescues cytoplasmic incompatibility in Drosophila melanogaster. Proc Natl Acad Sci U S A 115:4987-4991
Raybuck, Ariel L; Cho, Sung Hoon; Li, Jingxin et al. (2018) B Cell-Intrinsic mTORC1 Promotes Germinal Center-Defining Transcription Factor Gene Expression, Somatic Hypermutation, and Memory B Cell Generation in Humoral Immunity. J Immunol 200:2627-2639
McDonnell, Wyatt J; Koethe, John R; Mallal, Simon A et al. (2018) High CD8 T-Cell Receptor Clonality and Altered CDR3 Properties Are Associated With Elevated Isolevuglandins in Adipose Tissue During Diet-Induced Obesity. Diabetes 67:2361-2376
Wilson, Andrew J; Stubbs, Matthew; Liu, Phillip et al. (2018) The BET inhibitor INCB054329 reduces homologous recombination efficiency and augments PARP inhibitor activity in ovarian cancer. Gynecol Oncol 149:575-584
Williams, Michelle M; Lee, Linus; Werfel, Thomas et al. (2018) Intrinsic apoptotic pathway activation increases response to anti-estrogens in luminal breast cancers. Cell Death Dis 9:21
Ding, Tianbing; Mokshagundam, Shilpa; Rinaudo, Paolo F et al. (2018) Paternal developmental toxicant exposure is associated with epigenetic modulation of sperm and placental Pgr and Igf2 in a mouse model. Biol Reprod 99:864-876

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