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

为 NCI 中央机构审查委员会 (CIRB) 提供后勤和 IT 支持

• 批准号: 10470690
• 负责人: CLAUDINE VALMONTE
• 金额: $ 817.66万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10470690
• 关键词: Automation; Clinical Trials; Computers; Contracts; Enrollment; Ethics; Goals; Government; Human; Information Technology; Institution; Institutional Review Boards; Logistics; Methods; Modeling; Multicenter Trials; National Cancer Institute; Outcome; Participant; Patients; Protocols documentation; Regulation; Research; Research Personnel; Site; design; meetings; member; operation; programs; research study

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.

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，旨在为多中心、NCI申办的临床试验开发、实施和管理IRB审查的集中模式。该计划的目标有两个方面：通过提供可供参与NCI申办的多中心试验的当地IRB使用的单一、集中审查，简化监管合规性并减少目前在全国数百个当地IRB发生的重复方案审查负担;通过在国家层面提供一致的专家IRB审查，维持和加强对研究参与者的保护。本合同的目的是为政府提供IRB和其他联邦法规、IRB运营、伦理、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。