Rho Federal Systems Division, Inc. NIAID DAIT SACCC

该项目是DAIT统计和临床协调中心的一年延伸 (DAIT SACC）。延期将使服务能够保持至关重要的连续性， 授予承担DAIT SACC工作的合同，并进行任何必要的过渡。的 DAIT SACC支持哮喘和过敏性疾病，自身免疫性疾病， 移植DAIT SACC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。在扩展期间，DAIT SACC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 并将这些工作人员组织在一个有效管理资源的行政结构中， 研究联盟和DAIT的需求，并促进沟通和合作;（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， 设计和分析整个研究范围内的研究;（3）促进开发，审查， 通过专门的方案小组修订方案和方案相关文件; ⑷提供研究 启动和研究管理职能，以确保研究的有效性、有效性和伦理性; (5)提供完善的程序和人员来监测临床研究中心;（6）提供有效的 和准确的跟踪和核对标本采集和分发;（7）提供综合和 安全的信息管理系统和程序，用于收集临床和机械数据; (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， 规划，实施，分析和传播高维机制研究。

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.