NIAAA Medications Development Data Coordinating Center

NIAAA 药物开发数据协调中心

• 批准号: 7953228
• 负责人: JANET H RANSOM
• 金额: $ 310.85万
• 依托单位: FAST-TRACK DRUGS AND BIOLOGICS, LLC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-01-15 至 2011-07-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7953228
• 关键词: NIAAA; Medications; Development; Data; Coordinating

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to establish a Data Coordinating Center (DCC) capable of conducting all aspects of a multi-center clinical trial for the treatment of Alcohol Use Disorders using drug candidates. The Coordinating Center shall have the overall responsibility for the operation of the clinical trial including the trial schedule of activities, data management, medications packaging and distribution, and regulatory compliance support.

承包商应独立且不作为政府代理人提供建立数据协调中心 (DCC) 所需的所有必要服务、合格人员、材料、设备和设施（政府未另行提供）能够使用候选药物进行治疗酒精使用障碍的多中心临床试验的各个方面。协调中心全面负责临床试验的运作，包括试验活动安排、数据管理、药品包装和分发以及监管合规支持。