LOGISTICAL AND IT SUPPORT FOR THE NCI CENTRAL INSTITUTIONAL REVIEW BOARD (CIRB)

中央机构审查委员会(CIRB)计划是美国国家癌症研究所(NCI)的一个项目，旨在为NCI赞助的多地点临床试验开发、实施和管理IRB审查的集中模式。该倡议的目标有两个：通过提供可供参与NCI赞助的多中心试验的地方IRBs使用的单一、集中的审查，简化法规遵从性，减少目前在全国数百个地方IRB进行的方案审查的重复负担；通过在国家一级提供一致的、专家的IRB审查，维持并加强对研究参与者的保护。本合同的目的是向政府提供IRB和其他联邦法规、IRB操作、道德、质量、信息技术和项目管理方面的专业知识，以管理NCI CIRB并支持依赖它的机构。

The Central Institutional Review Board (CIRB) Initiative is a project of the National Cancer Institute (NCI) to develop, implement, and manage a centralized model of IRB review for multi-site, NCI-sponsored clinical trials. The goal of the Initiative is two-fold: to streamline regulatory compliance and decrease the duplicative burden of protocol review that currently occurs at hundreds of local IRBs nationwide by providing a single, centralized review that can be utilized by local IRBs participating in NCI-sponsored multi-center trials; and to maintain and enhance the protection of research participants by providing consistent, expert IRB review at the national level. The purpose of this contract is to provide the government with the expertise in IRB and other Federal regulations, IRB operations, ethics, quality, information technology, and program management necessary to manage the NCI CIRB and support the institutions that rely on it.