Rho Federal Systems Division, Inc. NIAID DAIT SACCC

项目摘要/摘要--总体构成部分 通过这一资助机会的宣布，NIAID过敏、免疫学和 移植(DAIT)打算整合其对多个独立统计和临床的资金 将协调中心(SACC)转化为单一的多组成部分合作协议，想必是为了减少 成本，提高效率和整个研究联盟的标准化。这项新计划将资助一项 单一SACCC或中心，以支持哮喘、过敏性疾病、自身免疫等领域的DAIT研究 疾病和移植。因为RHO目前是许多这些财团的SACCC和这些 SACC已经共享了一些资源和流程，RHO非常适合提供综合支持。 该中心的目标是为下列服务提供出色和有效的协调： 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。为了实现这些目标， RHO的目标是(1)提供在DAIT支持的财团进行的研究中经验丰富的人员，并组织 这些工作人员在一个有效管理资源的行政结构中，对 研究联合体和DAIT，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，设计和 分析整个研究范围内的研究；(3)促进开发、审查和修订初始 以及通过专门的协议小组连续起草协议和与协议有关的文件；(4) 提供高效、有效和符合道德规范所需的研究启动和研究管理职能 进行研究；(5)提供高素质和完善的程序和人员，以监测 临床地点；(6)提供有效和准确的样本收集和核对跟踪和核对 分发；(7)提供高质量、集成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)报告以及数据和安全监测委员会(DSMB)报告；以及(9)提供 规划、实施、分析和传播HIGH的工具、基础设施和分析支持 空间力学研究。 基于我们协调临床研究各个方面的丰富经验，我们计划使用我们的 当前的技术基础设施，结合新的创新技术，以：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； 实现中心人员配备和资源共享的灵活性；实现流程和方法的标准化 疾病组和集中组；并继续提供灵活性和必要性，以满足不断变化的 这一动态研究计划的需求。

PROJECT SUMMARY/ABSTRACT—OVERALL COMPONENT 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.