Rho Federal Systems Division, Inc. NIAID DAIT SACCC

Rho 联邦系统部, Inc. NIAID DAIT SACCC

• 批准号: 10457674
• 负责人: Samuel Arbes
• 金额: $ 350万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-31 至 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10457674
• 关键词: Allergic Disease; Applied Research; Area; Asthma; Autoimmune; Autoimmune Diseases; Basic Science; Bioinformatics; Biological Specimen Banks; Clinical; Clinical Investigator; Clinical Research; Clinical Trials Data Monitoring Committees; Collaborations; Collection; Communicable Diseases; Communication; Data; Data Analyses; Data Collection; Data Reporting; Development; Disease; Ensure; Ethics; Event; Funding; Funding Opportunities; Health; Human Resources; Hypersensitivity; Immune System Diseases; Immunology; Infrastructure; Laboratories; Management Information Systems; Metadata; Methodology; Mission; Monitor; National Institute of Allergy and Infectious Disease; Organ Transplant Research; Patients; Preparation; Procedures; Process; Protocols documentation; Publications; Randomized; Reporting; Research; Research Personnel; Resource Sharing; Resources; Safety; Scientist; Secure; Serious Adverse Event; Services; Solid; Standardization; Statistical Data Interpretation; Structure; Study Subject; System; Techniques; Technology; Testing; Training; Transplantation; U-Series Cooperative Agreements; Writing; base; clinical research site; cost; data management; data standards; design; experience; flexibility; high dimensionality; improved; innovation; instrument; meetings; member; patient safety; performance site; prevent; programs; protocol development; public repository; research study; rho; sample collection; statistics; tool

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.

项目摘要/摘要 - 所有组件 通过此资助机会公告，过敏，免疫学和 移植（DAIT）旨在巩固其用于多重，独立统计和临床的资金 协调中心（SACCC）纳入单个多组分合作协议，大概是为了减少 成本并提高研究财团的效率和标准化。这个新计划将资助 单个SACCC或中心，以支持哮喘和过敏性疾病领域的DAIT研究，自身免疫性 疾病和移植。因为Rho目前是其中许多财团的SACCC，而这些 SACCC已经共享了一些资源和流程，Rho非常适合提供合并的支持。 该中心的目的是提供以下服务的出色，有效的协调： 协议开发，研究计划和管理，统计设计和分析，临床现场监控， 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）为DAIT支持的财团进行的研究经验丰富并组织的工作人员 这些工作人员处于管理资源有效地管理资源的行政结构中，对 研究财团和dait，并促进沟通与协作； （2）经验丰富 科学家和统计学家，他们与临床研究人员和DAIT官员合作，设计和设计 分析整个研究范围的研究； （3）促进初始的开发，审查和修订 以及通过专门的协议团队成功的协议和协议相关文档的草案； （4） 提供研究计划和研究管理功能，这是有效，有效和道德的所需的 进行研究； （5）提供高质量且发达的程序和人员来监视 临床部位； （6）提供标本收集的有效，准确的跟踪和对帐， 分配; （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）通过提供高质量来帮助确保患者安全 严重的不良事件（SAE）报告和数据和安全监控委员会（DSMB）报告； （9）提供 在规划，实施，分析和传播高的工具，基础设施和分析支持 维度机械研究。 根据我们的丰富经验协调临床研究的各个方面，我们计划使用我们的 当前的技术基础设施，再加上新的和创新的技术：简化和自动化 过程；为DAIT，临床研究人员和其他主要研究利益相关者提供轻松获取数据； 允许灵活的中心人员配备和资源共享；标准化过程和方法 疾病组和集中群；并继续提供满足变化所必需的灵活性 对这个动态研究计划的要求。