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