Rho Federal Systems Division, Inc. NIAID DAIT SACCC

该项目是合并的DAIT统计和临床协调中心的一年延长 (DAIT SACCC)。延期将使关键的服务连续性成为可能，而个人继任者 授予承担DAIT SACCC工作的合同，并进行任何必要的过渡。这个 DAIT SACCC支持哮喘和过敏性疾病、自身免疫性疾病以及 移植。DAIT SACCC的目标是提供以下方面的有效协调 服务：方案制定、研究启动和管理、统计设计和分析、临床 现场监控、辅助服务、数据管理和安全监督。在延长期间，DAIT SACCC将继续(1)提供在DAIT支持的财团进行的研究方面经验丰富的工作人员 并将这些员工组织到一个有效管理资源的管理结构中，以响应 满足研究联合体和DAIT的需求，并促进沟通和协作；(2)提供 经验丰富的科学家和统计学家，他们与临床研究人员和DAIT官员合作， 在整个研究范围内设计和分析研究；(3)促进开发、审查和 通过专门的协议小组修订协议和协议相关文件；(4)提供研究 有效、有效和合乎道德地开展研究所需的启动和研究管理职能； (5)提供完善的程序和人员，以监测临床地点；。(6)提供有效率。 以及对标本收集和分发的准确跟踪和协调；(7)提供综合和 收集临床和机械数据的安全信息管理系统和程序； (8)通过提供高质量的严重不良事件(SAE)报告和数据，帮助确保患者安全 和安全监测委员会(DSMB)报告；以及(9)提供工具、基础设施和分析支持 高维机械研究的规划、实施、分析和传播。

This project is a one-year extension of the consolidated DAIT Statistical and Clinical Coordinating Center (DAIT SACCC). The extension will enable crucial continuity of services while the individual successor contracts assuming the work of the DAIT SACCC are awarded and any necessary transitions occur. The DAIT SACCC supports research in the areas of asthma and allergic diseases, autoimmune diseases, and transplantation. The objective of the DAIT SACCC is to provide efficient coordination of the following services: protocol development, study initiation and management, statistical design and analysis, clinical site monitoring, ancillary services, data management, and safety oversight. During the extension, the DAIT SACCC will continue to (1) provide staff experienced in research conducted by DAIT-supported consortia and organize these staff in an administrative structure that manages resources efficiently, is responsive to the needs of the research consortia and DAIT, and facilitates communication and collaboration; (2) provide experienced scientists and statisticians who, in collaboration with clinical investigators and DAIT officials, design and analyze studies across the full scope of research; (3) facilitate the development, review, and revision of protocols and protocol-related documents through dedicated protocol teams; (4) provide study initiation and study management functions required for the efficient, valid, and ethical conduct of studies; (5) provide well-developed procedures and personnel for the monitoring of clinical sites; (6) provide efficient and accurate tracking and reconciliation of specimen collection and distribution; (7) provide integrated and secure information management systems and procedures for the collection of clinical and mechanistic data; (8) help ensure patient safety by providing high-quality serious adverse event (SAE) reporting and Data and Safety Monitoring Board (DSMB) reports; and (9) provide tools, infrastructure, and analytical support in the planning, implementation, analysis, and dissemination of high dimensional mechanistic studies.