Rho Federal Systems Division, Inc. NIAID DAIT SACCC

 描述(由申请人提供)：通过这一资助机会公告，NIAID过敏、免疫学和移植司(DAIT)打算将其对多个独立的统计和临床协调中心(SACC)的资助合并为一个单一的多组件合作协议，可能是为了降低成本，提高研究联盟的效率和标准化。这一新计划将资助一个单一的SACCC或中心，以支持哮喘和过敏性疾病、自身免疫性疾病和移植领域的DAIT研究。由于RHO目前是其中许多财团的SACCC，而这些SACC已经共享了一些资源和流程，因此RHO非常适合提供综合支持。 该中心的目标是为以下服务提供出色而高效的协调：方案制定、研究启动和管理、统计设计和分析、临床现场监测、辅助服务、数据管理、安全监督和生物信息学。为达致这些目标，本组织的目标是(1)提供在由DAIT支持的财团进行的研究方面有经验的人员，并将这些人员组织成一个行政架构，有效地管理资源，回应研究财团和DAIT的需要，并促进沟通和协作；(2)提供有经验的科学家和统计学家，与临床研究人员和DAIT合作 官员，设计和分析整个研究范围内的研究；(3)通过专门的协议团队，促进协议和协议相关文件的初稿和后续草案的开发、审查和修订；(4)提供有效、有效和合乎道德的研究进行所需的研究启动和研究管理职能；(5)提供高质量和完善的程序和人员，用于监测临床现场；(6)提供对样本收集和分发的高效和准确的跟踪和协调；(7)为收集临床和机械数据提供高质量、集成和安全的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)报告以及数据和安全监测委员会(DSMB)报告，帮助确保患者安全；以及(9)在高维机械研究的规划、实施、分析和传播方面提供工具、基础设施和分析支持。 基于我们协调临床研究各个方面的丰富经验，我们计划使用我们现有的技术基础设施，结合新的和创新的技术来：简化和自动化流程；为DAIT、临床研究人员和其他关键研究利益相关者提供轻松的数据访问；允许灵活的中心人员配置和资源共享；标准化疾病组和集中式组的流程和方法；并继续提供必要的灵活性，以满足这一动态研究计划不断变化的需求。

 DESCRIPTION (provided by applicant): Through this Funding Opportunity Announcement, the NIAID Division of Allergy, Immunology and Transplantation (DAIT) intends to consolidate its funding for multiple, independent Statistical and Clinical Coordinating Centers (SACCCs) into a single multi-component cooperative agreement, presumably to reduce costs and increase efficiency and standardization across research consortia. This new program will fund a single SACCC, or Center, to support DAIT research in the areas of asthma and allergic diseases, autoimmune diseases, and transplantation. Because Rho is currently the SACCC for many of these consortia and these SACCCs already share some resources and processes, Rho is well suited to provide consolidated support. The objective of the Center is to provide excellent and efficient coordination of the following services: protocol development, study initiation and management, statistical design and analysis, clinical site monitoring, ancillary services, data management, safety oversight, and bioinformatics. To accomplish these objectives, Rho aims to (1) provide staff experienced in research conducted by DAIT-supported consortia and to 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 initial and successive drafts of protocols and protocol-related documents through dedicated protocol teams; (4) provide study initiation and study management functions that are required for the efficient, valid, and ethical conduct of studies; (5) provide high-quality and well-developed procedures and personnel for the monitoring of clinical sites; (6) provide the efficient and accurate tracking and reconciliation of specimen collection and distribution; (7) provide high-quality, 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. Based on our substantial experience coordinating all aspects of clinical research, we plan to use our current technology infrastructure, combined with new and innovative techniques to: streamline and automate processes; provide easy access to data for DAIT, clinical investigators, and other key research stakeholders; allow for flexibility of Center staffing and resource sharing; standardize processes and methodologies across disease groups and centralized groups; and continue to provide the flexibility necessity to meet the changing demands of this dynamic research program.