REGULATORY MANAGEMENT CENTER (RMC) - Infectious Diseases

监管管理中心 (RMC) - 传染病

• 批准号: 10788219
• 负责人: MATTHEW KIRKBY
• 金额: $ 419.75万
• 依托单位: PPD DEVELOPMENT LP
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-11-01 至 2023-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788219
• 关键词: Clinical; Clinical Research; Clinical Trials; Communicable Diseases; Conduct Clinical Trials; Contractor; Contracts; Dedications; Funding; Future; Grant; Individual; Industry Collaboration; Principal Investigator; Regulatory Affairs; Research Personnel; Services; U-Series Cooperative Agreements; clinical research site; programs

The purpose of this contract is to establish a Division-wide Regulatory Management Center to: (1) centralize all regulatory support services for DAIT-funded clinical research programs, currently carried out under multiple grants and contracts, into a single contract dedicated to regulatory affairs; (2) provide regulatory support services for individual clinical trial projects conducted under investigator-initiated cooperative agreement grants within a centralized contract; and (3) provide regulatory support services for future DAIT-supported clinical research programs and individual projects.

该合同的目的是建立一个范围内的监管管理中心：（1）将目前针对DAIT资助的临床研究计划的所有监管支持服务集中到目前根据多项赠款和合同进行的，归为专门用于监管事务的单一合同； （2）为调查员提出的集中合同中的合作协议赠款提供的个别临床试验项目提供监管支持服务； （3）为未来的dait临床研究计划和个别项目提供监管支持服务。