9.11 ABSTRACT University of Minnesota Cancer Center (UMCC) trial review and monitoring oversight is based on NCI/NIH guidelines to ensure the safety of participants and the validity of clinical trial data. Review of protocols for scientific merit and study progress is conducted by the Cancer Protocol Review Committees (CPRC). The responsibilities of the CPRCs are distinct from those of the Data and Safety Monitoring Council (DSMC) which has oversight of monitoring activities and data validity. The CPRCs review all University of Minnesota clinical cancer protocols including investigator initiated and industry-sponsored trials. The two CPRC committees are the Intervention Trials (CPRC-TI) Committee chaired by Robert Kratzke, MD, Chair and the Non-Therapeutic Intervention Trials (CPRC-NTI) Committee chaired by Julie Ross, PhD, Chair. The CPRCs may approve or disapprove a study for lack of scientific merit or progress. The DSMG chaired by Gregory Vercellotti, MD functions independently from the IRB and oversees data, safety and monitoring of ongoing clinical cancer trials. The DSMC primarily evaluates investigatOMnitiated trials. The DSMC makes recommendations to the Clinical Research Leadership Committee (CRL) to suspend or close a trial if the risk to subjects is thought to be excessive or to outweigh potential benefits. The DSMC Chair has the authority to temporarily suspend a trial without CRL approval in situations requiring immediate action. AUcommittee chairs are appointed by the Clinical Research Leadership Committee. The Cancer Center Clinical Trials office administratively supports the three committees.
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