Rho Federal Systems Division, Inc. NIAID DAIT SACCC

Rho 联邦系统部, Inc. NIAID DAIT SACCC

• 批准号: 9927567
• 负责人: Samuel Arbes
• 金额: $ 2263.83万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-07 至 2022-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9927567
• 关键词: Allergic Disease; Applied Research; Area; Asthma; Autoimmune Diseases; Autoimmune Process; 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 health relevance; public repository; research study; rho; sample collection; statistics; tool

 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.

 描述（由适用提供）：通过此资助机会公告，过敏，免疫学和移植（DAIT）的NIAID部门打算将其用于多个，独立统计和临床协调中心（SACCC）的资金巩固为单一的多组件合作协议，大概可以降低成本和跨越研究的配置，并提高研究成本和标准化。该新计划将资助单个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目前是许多这些财团的SACCC，并且这些SACCC已经共享了一些资源和流程，因此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）提供由dait支持的咨询的研究人员经验，并在有效地管理资源的行政结构中组织这些员工，对研究会议和dait的需求响应，并促进沟通和协作； （2）为经验丰富的科学家和统计学家提供与临床研究人员合作和DAIT合作 官员，设计和分析整个研究范围的研究； （3）通过专用协议团队支持协议和协议相关文档的初始和成功草案的开发，审查和修订； （4）提供研究计划和研究管理职能，这是研究的有效，有效和道德行为所必需的； （5）提供高质量且发达的程序和人员来监测临床部位； （6）提供标本收集和分布的有效，准确的跟踪和对帐； （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控委员会（DSMB）报告来帮助确保患者的安全； （9）在计划，实施，分析和传播高维机械研究的计划，基础架构和分析支持中。 根据我们协调临床研究各个方面的丰富经验，我们计划使用当前的技术基础设施，并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；标准化疾病群体和集中群体的过程和方法；并继续提供必要的灵活性，以满足该动态研究计划不断变化的需求。