Abstract

The Data and Safety Monitoring Committee is constituted according the HICCC NCI-approved Data and Safety Monitoring Plan. The DSMC meets monthly to review adverse event reporting and oversees the timeliness of adverse event reporting. The DSMC is responsible for institutional trials and for trials that do not have data and safety monitoring plans. With the implementation of the Velos information systems for data management of institutional clinical trials the DSMC will received real-time reporting on the timeliness of data entry and patient accrual to institutional trials. The DSMC files reports with the PRMC and can recommend closure or suspension of a study based on review of patient safety data.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA013696-37
Application #
8114090
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2010-07-01
Budget End
2011-06-30
Support Year
37
Fiscal Year
2010
Total Cost
$51,848
Indirect Cost

  Institution

Name
Columbia University (N.Y.)
Department
Type
DUNS #
621889815
City
New York
State
NY
Country
United States
Zip Code
10032

  Publications

Sengillo, Jesse D; Lee, Winston; Bilancia, Colleen G et al. (2018) Phenotypic expansion and progression of SPATA7-associated retinitis pigmentosa. Doc Ophthalmol 136:125-133
Moayedi, Yalda; Duenas-Bianchi, Lucia F; Lumpkin, Ellen A (2018) Somatosensory innervation of the oral mucosa of adult and aging mice. Sci Rep 8:9975
Hopkins, Benjamin D; Pauli, Chantal; Du, Xing et al. (2018) Suppression of insulin feedback enhances the efficacy of PI3K inhibitors. Nature 560:499-503
Kroeger, Heike; Grimsey, Neil; Paxman, Ryan et al. (2018) The unfolded protein response regulator ATF6 promotes mesodermal differentiation. Sci Signal 11:
Jauregui, Ruben; Thomas, Amanda L; Liechty, Benjamin et al. (2018) SCAPER-associated nonsyndromic autosomal recessive retinitis pigmentosa. Am J Med Genet A :
Ghorpade, Devram S; Ozcan, Lale; Zheng, Ze et al. (2018) Hepatocyte-secreted DPP4 in obesity promotes adipose inflammation and insulin resistance. Nature 555:673-677
Bianchetti, E; Bates, S J; Carroll, S L et al. (2018) Usp9X Regulates Cell Death in Malignant Peripheral Nerve Sheath Tumors. Sci Rep 8:17390
Jauregui, Ruben; Park, Karen Sophia; Duong, Jimmy K et al. (2018) Quantitative Comparison of Near-infrared Versus Short-wave Autofluorescence Imaging in Monitoring Progression of Retinitis Pigmentosa. Am J Ophthalmol 194:120-125
Proto, Jonathan D; Doran, Amanda C; Subramanian, Manikandan et al. (2018) Hypercholesterolemia induces T cell expansion in humanized immune mice. J Clin Invest 128:2370-2375
Shang, Enyuan; Zhang, Yiru; Shu, Chang et al. (2018) Dual Inhibition of Bcl-2/Bcl-xL and XPO1 is synthetically lethal in glioblastoma model systems. Sci Rep 8:15383

Showing the most recent 10 out of 331 publications