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 #
5P30CA013696-39
Application #
8375793
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
39
Fiscal Year
2012
Total Cost
$45,462
Indirect Cost
$17,234

  Institution

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

  Publications

Jauregui, Ruben; Park, Karen Sophia; Duong, Jimmy K et al. (2018) Quantitative progression of retinitis pigmentosa by optical coherence tomography angiography. Sci Rep 8:13130
O'Neil, Daniel S; Prigerson, Holly G; Mmoledi, Keletso et al. (2018) Informal Caregiver Challenges for Advanced Cancer Patients During End-of-Life Care in Johannesburg, South Africa and Distinctions Based on Place of Death. J Pain Symptom Manage 56:98-106
Liu, Katherine Y; Sengillo, Jesse D; Velez, Gabriel et al. (2018) Missense mutation in SLIT2 associated with congenital myopia, anisometropia, connective tissue abnormalities, and obesity. Orphanet J Rare Dis 13:138
Koch, Susanne F; Tsang, Stephen H (2018) Success of Gene Therapy in Late-Stage Treatment. Adv Exp Med Biol 1074:101-107
DiCarlo, James E; Mahajan, Vinit B; Tsang, Stephen H (2018) Gene therapy and genome surgery in the retina. J Clin Invest 128:2177-2188
Wert, Katherine J; Velez, Gabriel; Cross, Madeline R et al. (2018) Extracellular superoxide dismutase (SOD3) regulates oxidative stress at the vitreoretinal interface. Free Radic Biol Med 124:408-419
Lee, Andreia; CingÖz, Oya; Sabo, Yosef et al. (2018) Characterization of interaction between Trim28 and YY1 in silencing proviral DNA of Moloney murine leukemia virus. Virology 516:165-175
Schrank, Benjamin R; Aparicio, Tomas; Li, Yinyin et al. (2018) Nuclear ARP2/3 drives DNA break clustering for homology-directed repair. Nature 559:61-66
Proto, Jonathan D; Doran, Amanda C; Gusarova, Galina et al. (2018) Regulatory T Cells Promote Macrophage Efferocytosis during Inflammation Resolution. Immunity 49:666-677.e6
Hernandez, Celine; Huebener, Peter; Pradere, Jean-Philippe et al. (2018) HMGB1 links chronic liver injury to progenitor responses and hepatocarcinogenesis. J Clin Invest 128:2436-2451

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