CLINICAL TRIALS MONITORING SERVICE_ Moonshot support

这是一份研究和开发支持合同。此次收购的目的是协助NCI履行其作为IND申办者和资助机构对食品药品监督管理局（FDA）和卫生与公众服务部（DHHS）法规的责任。临床试验监测服务（CTMS）合同的范围是为NCI申办的临床试验提供数据管理、质量保证、临床试验监测和稽查能力，这些临床试验由NCI的实验治疗药物临床试验网络（ETCTN）在国内和国际参与研究中心进行。此外，CTMS合同还提供了一种对生物制药生产设施进行审计的机制，以确保符合现行的药品生产质量管理规范（GMP），并确保执行整体分析的实验室符合药物非临床研究质量管理规范（GLP）。

This is a Research and Development Support contract. The purpose of this acquisition is to assist the NCI in fulfilling its responsibilities to the Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations as IND sponsor and funding agency. The scope of the Clinical Trials Monitoring Service (CTMS) contract is to provide data management, quality assurance, clinical trial monitoring, and auditing capability for NCI sponsored clinical trials conducted by the NCI's Experimental Therapeutics Clinical Trials Network (ETCTN) at participating sites both domestically and internationally. Additionally, the CTMS contract provides a mechanism for the auditing of biopharmaceutical manufacturing facilities to ensure compliance with current Good Manufacturing Practices (GMP) and compliance with Good Laboratory Practices (GLP) for laboratories performing integral assays.