REGULATORY MANAGEMENT CENTER (RMC)

监管管理中心 (RMC)

• 批准号: 10672004
• 负责人: MATTHEW KIRKBY
• 金额: $ 100万
• 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 2022-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10672004
• 关键词: Clinical; Clinical Research; Clinical Trials; Conduct Clinical Trials; Contractor; Contracts; 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.

本合同的目的是建立一个部门范围的法规管理中心，以：（1）将目前在多个赠款和合同下开展的DAIT资助的临床研究项目的所有法规支持服务集中到一个专门用于法规事务的单一合同中;（2）为研究者开展的单个临床试验项目提供监管支持服务-在集中合同内启动合作协议赠款;（3）为未来DAIT支持的临床研究计划和单个项目提供监管支持服务。