Data And Safety Monitoring

University Of Southern California, Los Angeles CA

Investigators

Linked publications, trials & patents

Abstract

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.