RhoFED AA-SCCC

基本信息

批准号：
10746035
负责人：
Gloria David
金额：
$ 919.2万
依托单位：
RHO FEDERAL SYSTEMS DIVISION, INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-05-05 至 2028-04-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10746035
关键词：
Adverse event Allergic Disease Archives Asthma Biological Biological Specimen Banks Clinical Clinical Data Clinical Investigator Clinical Protocols Clinical Research Clinical Trials Data Monitoring Committees Clinical Trials Design Collaborations Communication Contractor Credentialing Data Databases Dedications Development Ensure Equipment and supply inventories Ethics Extrinsic asthma Funding Funding Opportunities Health Service Area Human Resources Hypersensitivity Infrastructure Internet Leadership Manuscripts Methodology Mission Modernization Monitor National Institute of Allergy and Infectious Disease Observational Study Participant Performance Persons Preparation Prevention strategy Process Protocols documentation Quality Control Reporting Research Research Design Research Personnel Research Support Resource Sharing Resources Safety Safety Management Sampling Scientific Evaluation Scientist Secure Services Site Specimen Standardization Statistical Data Interpretation Structure System Techniques Technology Training U-Series Cooperative Agreements United States Work Writing biobank clinical research site cost dashboard data management data sharing design experience flexibility improved innovation insight novel therapeutic intervention patient safety pharmacovigilance prevent programs protocol development quality assurance repository research study rho skills tool web page web portal

项目摘要

PROJECT SUMMARY/ABSTRACT The cooperative agreement funded by this Funding Opportunity Announcement establishes an Asthma and Allergy Statistical and Clinical Coordinating Center (AA-SCCC), which will further NIAID’s mission to support clinical research aimed at developing new or improved strategies to treat or prevent allergic diseases and asthma. The objective of the AA-SCCC is to provide excellent and efficient coordination of the following services: protocol development, study initiation and management, statistical design and analysis, and biological specimen repository management. To accomplish these objectives, Rho aims to (1) provide staff experienced in research conducted by NIAID-supported research networks and to organize these staff in an administrative structure that manages resources efficiently, is responsive to the needs of the research networks and NIAID, and facilitates communication and collaboration; (2) provide experienced scientists and statisticians who, in collaboration with clinical investigators and NIAID officials, design and analyze studies across the full scope of research; (3) facilitate the development, review, and revision of research 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) continuously monitor the accuracy and completeness of research data; (6) help ensure patient safety by providing high- quality adverse event surveillance and Data and Safety Monitoring Board (DSMB) reports; (7) provide for secure storage of biospecimens, along with their distribution for innovative mechanistic research; and (8) effectively collaborate with the other components of the NIAID clinical research program, e.g. the NIAID Regulatory Management Center (RMC), the Clinical Data and Safety Management Center (CDSMC), the Clinical Site Monitoring Center (CSMC), and the Clinical Products Center (CPC). Based on more than 25 years of experience coordinating all aspects of clinical research in asthma and allergic diseases, we will 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 staffing and resource sharing; standardize processes and methodologies across research networks where practicable; and continue to provide the flexibility necessity to meet the changing demands of this dynamic research program.

项目概要/摘要本次融资机会公告资助的合作协议建立了哮喘和过敏统计和临床协调中心 (AA-SCCC)，这将进一步履行 NIAID 的使命，以支持旨在开发新的或改进的策略来治疗或预防过敏性疾病的临床研究 AA-SCCC 的目标是提供以下方面的出色和高效的协调。服务：方案开发、研究启动和管理、统计设计和分析，以及为了实现这些目标，Rho 的目标是 (1) 提供人员。在 NIAID 支持的研究网络进行的研究方面拥有丰富的经验，并将这些工作人员组织成一个有效管理资源的行政结构，能够响应研究的需求 (2) 提供经验丰富的科学家和与临床研究人员和 NIAID 官员合作设计和分析研究的统计学家涵盖整个研究范围；(3) 促进研究方案的制定、审查和修订； (4) 提供学习启动和学习高效、有效和合乎道德地开展研究所需的管理职能；(5) 持续进行；监控研究数据的准确性和完整性；（6）通过提供高水平的信息来帮助确保患者安全。质量不良事件监测以及数据和安全监测委员会 (DSMB) 报告 (7) 提供；生物样本的安全储存及其用于创新机制研究的分配；以及 (8) 与 NIAID 临床研究项目的其他组成部分进行有效合作，例如 NIAID 监管管理中心 (RMC)、临床数据和安全管理中心 (CDSMC)、临床现场监测中心 (CSMC) 和临床产品中心 (CPC)。基于超过 25 年协调哮喘和过敏临床研究各个方面的经验疾病，我们将利用我们现有的技术基础设施，结合新技术和创新技术来：简化和自动化流程；为 DAIT、临床研究人员和其他关键人员提供轻松访问数据的途径研究利益相关者；允许人员配置和资源共享的灵活性；在可行的情况下跨研究网络采用方法论，并继续提供灵活性；满足这个动态研究计划不断变化的需求。