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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
3P30CA013696-39S3
Application #
8637181
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-07-04
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
39
Fiscal Year
2013
Total Cost
$136,392
Indirect Cost
$51,147
Name
Columbia University (N.Y.)
Department
Type
DUNS #
621889815
City
New York
State
NY
Country
United States
Zip Code
10032
Bassuk, Alexander G; Sujirakul, Tharikarn; Tsang, Stephen H et al. (2014) A novel RPGR mutation masquerading as Stargardt disease. Br J Ophthalmol 98:709-11
Li, Yao; Wu, Wen-Hsuan; Hsu, Chun-Wei et al. (2014) Gene therapy in patient-specific stem cell lines and a preclinical model of retinitis pigmentosa with membrane frizzled-related protein defects. Mol Ther 22:1688-97
Wert, Katherine J; Sancho-Pelluz, Javier; Tsang, Stephen H (2014) Mid-stage intervention achieves similar efficacy as conventional early-stage treatment using gene therapy in a pre-clinical model of retinitis pigmentosa. Hum Mol Genet 23:514-23
Shen, Sherry; Sujirakul, Tharikarn; Tsang, Stephen H (2014) Next-generation sequencing revealed a novel mutation in the gene encoding the beta subunit of rod phosphodiesterase. Ophthalmic Genet 35:142-50
Palomero, Teresa; Couronné, Lucile; Khiabanian, Hossein et al. (2014) Recurrent mutations in epigenetic regulators, RHOA and FYN kinase in peripheral T cell lymphomas. Nat Genet 46:166-70
Higuchi-Sanabria, Ryo; Pernice, Wolfgang M A; Vevea, Jason D et al. (2014) Role of asymmetric cell division in lifespan control in Saccharomyces cerevisiae. FEMS Yeast Res 14:1133-46
Lam, A T; Curschellas, C; Krovvidi, D et al. (2014) Controlling self-assembly of microtubule spools via kinesin motor density. Soft Matter 10:8731-6
Olszak, Torsten; Neves, Joana F; Dowds, C Marie et al. (2014) Protective mucosal immunity mediated by epithelial CD1d and IL-10. Nature 509:497-502
Murtomaki, Aino; Uh, Minji K; Kitajewski, Chris et al. (2014) Notch signaling functions in lymphatic valve formation. Development 141:2446-51
Nong, Eva; Lee, Winston; Merriam, Joanna E et al. (2014) Disease progression in autosomal dominant cone-rod dystrophy caused by a novel mutation (D100G) in the GUCA1A gene. Doc Ophthalmol 128:59-67

Showing the most recent 10 out of 142 publications