NINDS CENTER FOR CLINICAL RESEARCH

NINOS 临床研究部 (DCR) 负责确保 NINOS 资助的每个临床研究项目在实施和结果数据完整性方面达到最高质量，并确保遵守 DHHS/NIH/NINDS 有关人体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地利用资源，DCR 以 NINDS 临床研究资源中心的形式为 NINDS 资助的临床研究制定了与临床研究相关的科学和技术支持的计划要求。承包商应在质量控制/质量保证临床试验监测、统计和方法支持、临床数据采集和归档支持以及通用数据元素开发支持等领域为 NINOS 资助的临床研究的开展提供科学和技术支持。 基础合同的工作量要求水平代表了本质上持续且重复出现的可分割的服务。尽管该合同具有广泛的履约历史，但即使在合理的估计范围内，NINDS 仍然无法知道在任何给定年份履行工作说明书中包含的四个绩效领域支持职能（临床研究中的监测质量保证/质量控制；统计和方法支持；临床数据采集和归档；以及通用数据元素支持）所需采取的确切行动方案。因此，NINDS 可以公平地讨价还价的最多是承包商拥有并提供一支能够致力于确定的具体绩效要求的人员队伍。因此，承包商的履约义务和政府的需求只能根据每年、每 12 个月期间可提供的预期努力水平来定义，作为定义承包商的履约义务和政府对基本要求的需求的一种手段。 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，并适用于基本合同和如此行使的每个连续选择期。

The NINOS 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.