CANCER PREVENTION CLINICAL TRIALS AUDITING & INFORMATICS SUPPORT

美国国家癌症研究所癌症预防部（NCI DCP）开展并支持研究，以确定一个人患癌症的风险，并找到降低这种风险的方法。NCI DCP管理一系列科学和临床活动，包括识别和开发具有潜在癌症预防活动的化学预防剂和干预措施，进行临床前研究，进行测试剂和干预措施的I期和II期试验，以及将有希望的药物和干预措施纳入更大的III期癌症预防临床试验。这些癌症预防试验是由校外研究者在国家和国际临床站点进行的。

The National Cancer Institute Division of Cancer Prevention (NCI DCP) conducts and supports research to determine a person's risk of developing cancer and to find ways to reduce that risk. 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 I and Phase 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 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 I, Phase II, and selected Phase III cancer prevention clinical trials sponsored by NCI DCP.