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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.

项目总结/文摘