PROTOCOL REVIEW AND MONITORING SYSTEM

自1996年1月以来，一个科学审查委员会(临床癌症研究委员会)和一个 安全和数据监测委员会(SDMC)已经在诺里斯棉花癌症中心发挥作用。中华全国总商会 在机构审查委员会(IRB)审查之前，审查每个新的临床试验方案，以及国家药品监督管理委员会 在整个试验过程中定期监测安全性和数据完整性。在IRB审查之前，NCCC 临床研究办公室(OCR)向CCRC提交了该方案。中国保监会负责 对所有涉及癌症患者或人类癌症预防的新研究进行科学审查。这 评估涉及对研究的所有科学方面的审查，包括所需的安全性和数据 监测计划。一旦协议获得CCRC和IRB的批准，该协议就被认为是开放的 激活。

Since January 1996, a scientific review committee (Clinical Cancer Research Committee¿CCRC) and a Safety and Data Monitoring Committee (SDMC) have functioned at Norris Cotton Cancer Center. The CCRC reviews each new clinical trial protocol prior to Institutional Review Board (IRB) review, and the SDMC monitors safety and data integrity on a regular basis throughout the trial. Prior to IRB review, the NCCC Office of Clinical Research (OCR) submits the protocol to the CCRC. The CCRC is responsible for the scientific review of all new studies involving cancer patients or cancer prevention in human subjects. This assessment involves a review of all scientific aspects of the study, including the required safety and data monitoring plan. Once a protocol receives CCRC and IRB approval, the protocol is considered open for activation.