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.

项目总结/摘要-总体组件 通过这一资助机会公告，NIAID过敏，免疫学和 移植（DAIT）打算巩固其多个，独立的统计和临床 协调中心（SACCs）合并为一个单一的多组成部分合作协议， 成本，提高效率和标准化的研究联盟。这一新项目将为A 单一SACC或中心，以支持DAIT在哮喘和过敏性疾病，自身免疫性疾病， 疾病和移植。由于Rho目前是许多财团的SACC，因此 SACCC已经共享了一些资源和流程，Rho非常适合提供统一的支持。 该中心的目标是提供以下服务的出色和有效的协调： 方案制定、研究启动和管理、统计设计和分析、临床研究中心监查， 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旨在（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，并组织 这些工作人员在一个有效管理资源的行政结构中， 研究联盟和DAIT，并促进沟通和合作;（2）提供经验丰富的 科学家和统计学家与临床研究人员和DAIT官员合作， 分析整个研究范围内的研究;（3）促进初步的发展，审查和修订 以及通过专门的礼宾小组起草礼宾和与礼宾有关的文件;（4） 提供研究启动和研究管理功能，以确保有效、有效和符合伦理 （5）提供高质量和完善的程序和人员，以监测 临床研究中心;（6）提供有效和准确的样本采集跟踪和核对， 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）报告和数据与安全性监查委员会（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 维度机制研究。 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，结合新的和创新的技术：简化和自动化 为DAIT、临床研究者和其他关键研究利益相关者提供轻松访问数据的途径; 允许中心人员配置和资源共享的灵活性;标准化跨中心的流程和方法 疾病组和集中组;并继续提供必要的灵活性，以满足不断变化的 这一动态研究计划的需求。