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）在诺里斯棉花癌症中心发挥作用。的CCRC 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，SDMC 在整个试验期间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）将方案提交给CCRC。CCRC负责 对所有涉及癌症患者或人类受试者癌症预防的新研究进行科学审查。这 评估包括对研究的所有科学方面进行审查，包括所需的安全性和数据 监测计划。一旦方案获得CCRC和IRB批准，该方案被视为开放供 activation.

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.