DATA and SAFETY MONITORING

$50,766P30FY2011CANIH

Columbia University Health Sciences, New York NY

Investigators

Linked publications & trials

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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.

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