CANCER PREVENTION CLINICAL TRIALS AUDITING AND INFORMATICS SUPPORT

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The National Cancer Institute Division of Cancer Prevention (NCI DCP) conducts and supports research in cancer prevention, early detection and screening, and on the prevention and management of symptoms and toxicities in cancer patients. As an extramural division, DCP supports and promotes investigators around the country and internationally in these critical areas of cancer science. NCI DCP manages a portfolio of scientific and clinical activities that includes identifying and developing chemopreventive agents and interventions with potential cancer prevention activity, performing pre-clinical studies, conducting Phase 0/I/II trials for testing agents and interventions, and moving promising agents and interventions into larger Phase III cancer prevention clinical trials. These cancer prevention trials are conducted by extramural investigators at national and international clinical sites. As a sponsor of a trial, NCI DCP is responsible for ensuring that clinical trials are conducted safely and according to protocol, from the initial safety studies through the definitive evaluation of the role of the new agent or intervention in the prevention of specific types of cancer. Fulfillment of this responsibility requires careful and thorough auditing and monitoring of a clinical trial throughout its entire process including the verification of clinical trials data as well as investigator and study site compliance with the protocol, Good Clinical Practice Guidelines, applicable regulatory requirements and clinical trials policies. The Cancer Prevention Clinical Trials Auditing and Informatics Support contract provides comprehensive clinical trial oversight capability for the Phase 0/I/II and selected Phase III cancer prevention clinical trials sponsored by NCI DCP.