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 #
8545037
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

Choksi, Yash A; Reddy, Vishruth K; Singh, Kshipra et al. (2018) BVES is required for maintenance of colonic epithelial integrity in experimental colitis by modifying intestinal permeability. Mucosal Immunol 11:1363-1374
Elion, David L; Cook, Rebecca S (2018) Harnessing RIG-I and intrinsic immunity in the tumor microenvironment for therapeutic cancer treatment. Oncotarget 9:29007-29017
Kook, Seunghyi; Qi, Aidong; Wang, Ping et al. (2018) Gene-edited MLE-15 Cells as a Model for the Hermansky-Pudlak Syndromes. Am J Respir Cell Mol Biol 58:566-574
Chavez, Diana A; Greer, Briana H; Eichman, Brandt F (2018) The HIRAN domain of helicase-like transcription factor positions the DNA translocase motor to drive efficient DNA fork regression. J Biol Chem 293:8484-8494
Cooke, Allison L; Morris, Jamie; Melchior, John T et al. (2018) A thumbwheel mechanism for APOA1 activation of LCAT activity in HDL. J Lipid Res 59:1244-1255
Yang, Yaohua; Cai, Qiuyin; Shu, Xiao-Ou et al. (2018) Prospective study of oral microbiome and colorectal cancer risk in low-income and African American populations. Int J Cancer :
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
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
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

Showing the most recent 10 out of 2462 publications