DATA AND SAFETY MONITORINGThe Data and Safety Monitoring Plan (DSMP) of the Kimmel Cancer Center (KCC) provides for theoversight and monitoring of clinical trials to ensure the:1. Safety of patients; and2. Validity and integrity of the data collected on these trials.Responsibility for data and safety monitoring at Thomas Jefferson University resides in:1. The Clinical Cancer Research Review Committee (CCRRC) which oversees the scientific review ofall new and ongoing cancer-related clinical trials within the KCC;2. The Clinical Research Management Office (CRMO) which provides strategic assistance and supportto the CCRRC;3. The IRB which has primary responsibility for the protection of the welfare of human subjects involvedin biomedical and behavioral research. The IRB has full authority to approve, request modificationsprior to approval, disapprove, suspend or terminate for cause all research activities that fall within itsjurisdiction; and4. The Data and Safety Monitoring Boards (DSMB), which are responsible for data and safetymonitoring of Kimmel Cancer Center investigator initiated trials (KCC NT).The DSMP requires that every Kimmel Cancer Center protocol include a Data and Safety Monitoring plan.The CCRRC will not review a study that does not have such a plan, and the TJU IRB will not accept a studyfor review and approval until it has been approved by the CCRRC.
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