Project-002

项目-002

• 批准号: 10594708
• 负责人: Gloria David
• 金额: $ 181.34万
• 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 2023-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10594708
• 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 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（由申请人提供）：通过本资助机会公告，NIAID 过敏、免疫学和移植部门 (DAIT) 打算将其对多个独立统计和临床协调中心 (SACCC) 的资助整合为一个单一的多组成部分合作协议，大概是为了降低研究联盟的成本并提高效率和标准化。这项新计划将资助一个 SACCC（即中心），以支持 DAIT 在哮喘和过敏性疾病、自身免疫性疾病和移植领域的研究。由于 Rho 目前是许多此类联盟的 SACCC，并且这些 SACCC 已经共享一些资源和流程，因此 Rho 非常适合提供综合支持。 该中心的目标是提供以下服务的卓越和高效的协调：方案开发、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 支持的联盟进行研究方面经验丰富的工作人员，并将这些人员组织到一个能够有效管理资源、响应研究联盟和 DAIT 的需求并促进沟通与协作； (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 合作 官员，设计和分析整个研究范围的研究； (3) 通过专门的议定书小组，促进议定书初稿和后续草案以及议定书相关文件的制定、审查和修订； (4) 提供高效、有效和合乎道德的研究行为所需的研究启动和研究管理职能； (5) 为临床场所的监测提供高质量和完善的程序和人员； （6）提供标本采集和分发的高效、准确的跟踪和核对； (7) 为临床和机械数据的收集提供高质量、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； (9) 为高维机制研究的规划、实施、分析和传播提供工具、基础设施和分析支持。 基于我们在协调临床研究各个方面的丰富经验，我们计划利用我们当前的技术基础设施，结合新的创新技术来：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访问数据的能力；允许中心人员配置和资源共享的灵活性；跨疾病组和集中组标准化流程和方法；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。