CANCER PREVENTION CLINICAL TRIALS AUDITING AND INFORMATICS SUPPORT

美国国家癌症研究所癌症预防部（NCI DCP）开展并支持癌症预防、早期发现和筛查以及癌症患者症状和毒性的预防和管理方面的研究。作为一个校外部门，DCP支持和促进全国和国际上癌症科学这些关键领域的研究人员。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0/I/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。作为一项试验的发起人，NCI DCP负责确保临床试验安全并按照方案进行，从最初的安全性研究到对新药或干预措施在预防特定类型癌症中的作用的最终评估。履行这一职责需要对临床试验的整个过程进行仔细和彻底的审计和监控，包括临床试验数据的验证，以及研究者和研究地点对方案、良好临床实践指南、适用的监管要求和临床试验政策的遵守。癌症预防临床试验审计和信息支持合同为NCI DCP赞助的0/I/II期和选定的III期癌症预防临床试验提供全面的临床试验监督能力。

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.