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的最高质量在行为和所得数据的完整性方面，并确保遵守DHHS/NIH/NIHS关于人类主体保护和安全监控的法规。为了确保最高质量的产品和最有效利用资源，DCR建立了针对NINDS临床研究资源中心的形式的临床研究相关的科学和技术支持的程序要求。承包商应为在质量控制/质量保证临床试验，统计和方法学支持，临床数据获取和归档支持以及共同数据元素开发支持方面的领域提供尼诺斯赞助的临床研究的科学和技术支持。 基本合同的努力要求水平代表了可分割的服务，这些服务本质上仍在继续和反复出现。尽管该合同具有广泛的绩效历史记录，但即使在合理的估计范围内，NINDS仍然无法了解，以执行工作表中包含的四个绩效领域支持功能（监视质量质量保证/质量控制在临床研究中；统计学和方法支持；统计学数据和归档数据元素；以及任何给定数据元素）。因此，Ninds最讨价还价的最多的是承包商已提供并提供一组人员，以便能够在确定的情况下专门遵守特定的绩效要求。因此，只有根据可以每年的12个月期间提供的预期努力水平来定义承包商的绩效义务和政府的需求，以定义承包商绩效义务以及政府对基本要求的需求。包括成本的限制，以远处为52.232-20的条款被纳入本合同的一部分，并适用于基本合同和随后进行的每个连续期权期。