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

Cardin, Dana B; Thota, Ramya; Goff, Laura W et al. (2018) A Phase II Study of Ganetespib as Second-line or Third-line Therapy for Metastatic Pancreatic Cancer. Am J Clin Oncol 41:772-776
Bloodworth, Melissa H; Rusznak, Mark; Pfister, Connor C et al. (2018) Glucagon-like peptide 1 receptor signaling attenuates respiratory syncytial virus-induced type 2 responses and immunopathology. J Allergy Clin Immunol 142:683-687.e12
Saito-Diaz, Kenyi; Benchabane, Hassina; Tiwari, Ajit et al. (2018) APC Inhibits Ligand-Independent Wnt Signaling by the Clathrin Endocytic Pathway. Dev Cell 44:566-581.e8
Dutter, Brendan F; Ender, Anna; Sulikowski, Gary A et al. (2018) Rhodol-based thallium sensors for cellular imaging of potassium channel activity. Org Biomol Chem 16:5575-5579
Hormuth 2nd, David A; Weis, Jared A; Barnes, Stephanie L et al. (2018) Biophysical Modeling of In Vivo Glioma Response After Whole-Brain Radiation Therapy in a Murine Model of Brain Cancer. Int J Radiat Oncol Biol Phys 100:1270-1279
Rojas, Juan D; Lin, Fanglue; Chiang, Yun-Chen et al. (2018) Ultrasound Molecular Imaging of VEGFR-2 in Clear-Cell Renal Cell Carcinoma Tracks Disease Response to Antiangiogenic and Notch-Inhibition Therapy. Theranostics 8:141-155
Lewis Jr, James S; Shelton, Jeremy; Kuhs, Krystle Lang et al. (2018) p16 Immunohistochemistry in Oropharyngeal Squamous Cell Carcinoma Using the E6H4 Antibody Clone: A Technical Method Study for Optimal Dilution. Head Neck Pathol 12:440-447
Vierra, Nicholas C; Dickerson, Matthew T; Jordan, Kelli L et al. (2018) TALK-1 reduces delta-cell endoplasmic reticulum and cytoplasmic calcium levels limiting somatostatin secretion. Mol Metab 9:84-97
Schlegel, Cameron; Weis, Victoria G; Knowles, Byron C et al. (2018) Apical Membrane Alterations in Non-intestinal Organs in Microvillus Inclusion Disease. Dig Dis Sci 63:356-365
Piñeros, Marion; Frech, Silvina; Frazier, Lindsay et al. (2018) Advancing Reliable Data for Cancer Control in the Central America Four Region. J Glob Oncol :1-11

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