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中文摘要
翻译
本任务订单的目的是为NIEHS合同提供与临床研究支持服务的行政职能和活动相关的技术支持、管理和协作。 此任务订单将包含多个克隆。除了为合同的核心功能提供支持外,预计此任务订单还将支持与工作相关的离散工作,但可能不保证授予单独的任务订单,如试点、纵向和可行性研究、小规模或持续时间的工作、附加研究、小项目等。 与支持临床合同的核心功能活动相关的工作将在本任务单CLIN1:核心功能活动下提供。其他相关工作可纳入本任务单中单独的CLINS项下。每个项目的具体目标将有所不同,但一般支持可能包括为内部审查委员会[IRB]和联邦药物管理局[FDA]提交的法规文件、受试者招募、受试者登记、数据和安全管理以及其他礼仪相关活动。 CLIN1的目的是提供与临床研究支持服务合同的核心行政职能和活动相关的技术支持、管理和协作。根据CLIN1,承包商应为合同中其他任务单项下提供的工作提供项目管理和支持。
英文摘要
The purpose of this task order is to provide technical support, management, and collaboration as associated with administrative functions and activities of the Clinical Research Support Services for the NIEHS Contract. This Task Order will incorporate multiple CLINs. In addition to providing support for the core functions of the Contract, it is anticipated that this Task Order will also support discrete efforts that are related to the work, but may not warrant award of a separate Task Order, such as pilot, longitudinal, and feasibility studies, efforts of small size or duration, add-on studies, small projects, etc. The work associated with the support of the core function activities of the Clinical contract will be provided under this Task Order CLIN1: Core Function Activities. Additional related work may be incorporated to this Task Order under separate CLINs. The specific aims of each project will vary but general support may include preparation of regulatory documents for Internal Review Board [IRB] and Federal Drug Administration [FDA] submissions, subject recruitment, subject enrollment, data and safety management and other protocol related activities. The purpose of CLIN1 is to provide technical support, management, and collaboration as associated with core administrative functions and activities of the Clinical Research Support Services contract. Under CLIN1, the Contractor shall provide project administration and support to the work provided under other Task Orders in the contract.
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TASK ORDER 5R - PERSONALIZED ENVIRONMENT AND GENES STUDY (PEGS)
TASK ORDER 5R - PERSONALIZED ENVIRONMENT AND GENES STUDY (PEGS)
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