CLINICAL AND REGULATORY OPERATIONS CENTER

临床和监管运营中心

• 批准号: 2600889
• 负责人: CATHY MCDERMOTT
• 金额: $ 222.38万
• 依托单位: SOCIAL AND SCIENTIFIC SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-10-03 至 2002-10-02
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2600889
• 关键词: AIDS; biomedical registry /referral center; clinical research; human data

This contract supports the Therapeutics Research Program (TRP), within the Division of Acquired Immunodeficiency Syndrome (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID). The Contractor shall establish and maintain a Clinical and Regulatory Operations Center (CROC), which will support the AIDS Clinical Trials Groups (ACTG), the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), the AIDS Vaccine Evaluation Group (AVEG), the HIV Vaccine Efficacy Trials Network (HIVNET) and the intramural Research Program (IRP) with regulatory and technical functions related to drug and vaccine clinical trials. Major project activities will include assembly and submission of INDs, amendments and annual reports; coordination of adverse experience reporting, initial medical evaluation of adverse experience reports, research assistance for preparation of safety reports and other research synthesis; coordination of site registration; and operational support for the AIDS Clinical Drug Development Committee and development of clinical trials agreements between industry and DAIDS. In addition, the CROC will provide technical support for DAIDS reviews of concept sheets and final protocols for the ACTG, CPCRA, and DATRI; provide technical support for Data and Safety Monitoring Boards; arrange logistics for national ACTG scientific meetings, and maintain a management information system for rapid retrieval and distribution of information related to the centrally coordinated activities.

该合同支持治疗研究计划（TRP） 国家研究所获得的免疫缺陷综合征（DAIDS）部 过敏和传染病（NIAID）。 承包商应建立并维护临床和监管 运营中心（CROC），该中心将支持AIDS临床试验 小组（ACTG），Terry Beirn社区计划，用于临床研究 AIDS（CPCRA），艾滋病疫苗评估组（AVEG），HIV疫苗 功效试验网络（HIVNET）和壁内研究计划（IRP） 具有与药物和疫苗有关的调节和技术功能 临床试验。主要项目活动将包括集会和 提交IND，修正和年度报告；不利的协调 经验报告，不利经验的初步医学评估 报告，准备安全报告的研究帮助和其他 研究综合；现场注册的协调；和运营 支持艾滋病临床药物开发委员会和发展 工业和妻子之间的临床试验协议。另外， CROC将为DAIDS评论概念表提供技术支持 以及ACTG，CPCRA和DATRI的最终协议；提供技术 支持数据和安全监控板；安排物流 国家ACTG科学会议，并维护管理信息 快速检索和分发与该信息有关的系统 集中协调的活动。