RhoFED AA-SCCC

项目总结/摘要 由本资助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NIAID的使命，以支持 临床研究，旨在开发新的或改进的策略，以治疗或预防过敏性疾病， 哮喘AA-SCCC的目标是为以下方面提供出色和有效的协调 服务：方案制定、研究启动和管理、统计设计和分析，以及 生物标本库管理。为了实现这些目标，Rho旨在（1）提供员工 在NIAID支持的研究网络进行的研究中有经验，并将这些工作人员组织在一个 一个有效管理资源的行政结构，对研究的需要作出反应 网络和NIAID，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者和NIAID官员合作，设计和分析研究 （3）促进研究方案的制定、审查和修订， 通过专门的方案团队提供方案相关文件;（4）提供研究启动和研究 有效、有效和合乎伦理地开展研究所需的管理职能;（5）持续 监测研究数据的准确性和完整性;（6）通过提供高质量的 质量不良事件监测和数据与安全监测委员会（DSMB）报告;（7）规定 生物标本的安全储存，沿着它们的分配，用于创新的机理研究;以及（8） 与NIAID临床研究计划的其他组成部分（如NIAID）进行有效合作 法规管理中心（RMC）、临床数据和安全性管理中心（CDSMC）、 临床研究中心监查中心（CSMC）和临床产品中心（CPC）。 基于超过25年的经验，协调哮喘和过敏性疾病临床研究的各个方面 我们将利用我们现有的技术基础设施，结合新的和创新的技术： 简化和自动化流程;为DAIT、临床研究者和其他关键人员提供轻松访问数据的机会 研究利益相关者;允许人员配置和资源共享的灵活性;标准化流程， 在可行的情况下，在研究网络中采用各种方法;并继续提供必要的灵活性， 满足这一动态研究计划不断变化的需求。

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.