NINDS CENTER FOR CLINICAL RESEARCH

NINDS 临床研究中心

• 批准号: 10400617
• 负责人: TRACI E CLEMONS
• 金额: $ 135.24万
• 依托单位: THE EMMES COMPANY, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2022-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10400617
• 关键词: Area; Charge; Clinical Data; Clinical Research; Common Data Element; Contractor; Contracts; Data; Development; Ensure; Exercise; Funding; Government; Human Resources; Methodology; Monitor; Monitoring Clinical Trials; National Institute of Neurological Disorders and Stroke; Nature; Performance; Quality Control; Recording of previous events; Regulation; Research Project Grants; Resources; Safety; Services; United States National Institutes of Health; Work; archive data; base; clinical center; cost; data acquisition; data archive; human subject protection; quality assurance

The NINDS Division of Clinical Research (DCR) is charged with ensuring the highest quality of each NINOS-funded clinical research project in terms of both conduct and the integrity of resultant data and\ ensuring compliance with DHHS/NIH/NINDS regulations regarding human subject protection and safety monitoring. To ensure the highest quality product and most efficient use of resources, DCR has established a programmatic requirement for clinical research-related scientific and technical support for NINDS-sponsored clinical research in the form of an NINDS Center for Clinical Research Resources. The Contractor shall provide scientific and technical support toward the conduct of NINOS-sponsored clinical research in the areas of Quality Control/Quality Assurance clinical trial monitoring, statistical and methodological support, clinical data acquisition and archiving support and common data element development support. The level of effort requirements of the base contract represent severable services that are continuing and recurring in nature. Despite the extensive performance history of this contract, the NINDS still have no way of knowing, even within a reasonable range of estimation, the exact course of action that will need to be taken in order to perform the four Performance Area support functions contained in the Statement of Work (Monitor Quality Assurance/Quality Control in Clinical Research; Statistical and Methodological Support; Clinical Data Acquisition and Archiving; and Common Data Element support) in any given year. Therefore, the most that the NINDS can fairly bargain for is that the Contractor have available and provide a cadre of personnel to be able to devote to the specific performance requirements as they are identified. Thereby, the Contractor's performance obligation and the Government's need can only be defined in terms of the expected level of effort that can be provided on an annual basis, for each 12 month period, as a means of defining the Contractors performance obligation and the Government's need for the basic requirement. The clause at FAR 52.232-20, Limitation of Cost, is included and is made a part of this contract and applies to the base contract and each successive option period so exercised.

NINDS临床研究部（DCR）负责确保每个NINOS资助的临床研究项目在实施和所得数据的完整性方面的最高质量，并确保符合DHHS/NIH/NINDS关于人类受试者保护和安全监测的法规。为了确保最高质量的产品和最有效的资源利用，DCR已经建立了一个NINDS临床研究资源中心形式的临床研究相关的科学和技术支持的NINDS申办的临床研究的程序要求。承包商应在质量控制/质量保证临床试验监测、统计和方法学支持、临床数据采集和存档支持以及通用数据元素开发支持方面为NINOS申办的临床研究的开展提供科学和技术支持。 基本合同的工作量要求是指连续性和经常性的可分割服务。尽管本合同有着广泛的执行历史，但NINDS仍然无法知道（即使在合理的估计范围内）为执行工作说明书中包含的四个性能领域支持功能而需要采取的确切行动方案（监察临床研究的质量保证/质量控制;统计及方法学支援;临床数据收集及分析;和公共数据元素支持）。因此，NINDS可以公平讨价还价的最多是承包商拥有并提供一批人员，以便能够致力于确定的特定性能要求。因此，承包商的履约义务和政府的需要只能根据每年每12个月的预期努力水平来界定，以此作为界定承包商履约义务和政府对基本要求的需要的一种手段。FAR 52.232-20中的条款“成本限制”已包含在本合同中，并成为本合同的一部分，适用于基础合同和每次连续行使的期权期。