The NCI mandates that all CCSG-funded cancer centers establish a protocol review and monitoring system for oversight of the clinical research conducted at that institution. At the USC Norris Comprehensive Cancer Center (NCCC), the Clinical Investigations Committee (CIC) has this responsibility. The CIC performs the scientific review of proposed cancer clinical studies, and oversees the conduct of all clinical studies open at the NCCC. To facilitate the oversight of open trials, the internal Data and Safety Monitoring Committee (DSMC) will meet monthly to review institutional clinical trials (i.e., cancer-related trials involving an intervention where a USC investigator is the overall principal investigator (PI) of the study and the trial is not part of a national cooperative group or the CCCP Consortium, or sponsored by a pharmaceutical company that will responsible for the data management and oversight of the progress of the trial). Each in-house trial will be reviewed annually or more frequently as determined by the CIC. The reviews of the DSMC complement those of the QAMC, a long-standing Cancer Center committee which is charged with (among other responsibilities) reviewing accrual, and SAE's and major violations in a timely fashion, for all open protocols, as well as conducting audits of patients on institutional clinical trials. The DSMC will work in close coordination with the Clinical Investigations Support Office, which plays the main role of coordinating the conduct of clinical research in the NCCC. The objectives of the DSMC are to: 1. review, at established intervals, safety and aspects of the protocol and study conduct that may impact on safety of current or future patients 2. review all serious adverse events or other adverse events that require expedited reporting 3. review the progress of the study 4. review efficacy results that trigger early closure or early reporting 5. review the completeness and the quality of the research data 6. report the results of each review and make recommendations to the study PI, IRB, the Quality Assurance Monitoring Committee and the CIC.

Public Health Relevance

It is the responsibility of the NCCC to ensure that the trials undertaken at the Cancer Center are scientifically sound and conducted in a rigorous fashion so as to yield timely and meaningful data in order to advance the development of effective diagnostics and treatments. The DSMC will monitor the safety of NCCC institutional trials to ensure patient safety and timely study completion with high quality results.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA014089-39
Application #
8589365
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-12-01
Budget End
2014-11-30
Support Year
39
Fiscal Year
2014
Total Cost
$143,994
Indirect Cost
$52,397
Name
University of Southern California
Department
Type
DUNS #
072933393
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
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