RhoFED T-SCCC

RhoFED T-SCCC

• 批准号: 10745900
• 负责人: Brian Armstrong
• 金额: $ 149.41万
• 依托单位: RHO FEDERAL SYSTEMS DIVISION, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-05 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10745900
• 关键词: Biological; Biological Markers; Biometry; Clinical; Clinical Data; Clinical Research; Clinical Trials; Collaborations; Collection; Communication; Data; Databases; Development; Ensure; Funding; Funding Opportunities; Human Resources; Hypersensitivity; Immunology; Infrastructure; Intervention; Label; Laboratories; Leadership; Manuscripts; Monitor; National Institute of Allergy and Infectious Disease; Online Systems; Organ Transplant Research; Organ Transplantation; Preparation; Protocols documentation; Reporting; Research; Research Design; Research Personnel; Research Support; Resources; Safety; Safety Management; Sampling; Services; Shipping; Site; Statistical Data Interpretation; Structure; System; Testing; Training; Training Activity; Transplantation; U-Series Cooperative Agreements; Visit; Work; clinical research site; data exchange; data integrity; data management; design; experience; member; operation; programs; protocol development; rho; sample collection; web platform

PROJECT SUMMARY/ABSTRACT Through this Funding Opportunity Announcement, NIAID is establishing a Transplantation Statistical and Clinical Coordinating Center (T-SCCC) to provide statistical design and analysis, study management, and biospecimen support services for transplant studies funded through NIAID-supported research networks, including ITN, CTOT, and CTOT-CA. As the current NIAID Division of Allergy, Immunology and Transplantation Statistical and Clinical Coordinating Center (DAIT SACCC) providing statistical design and analysis, study management, and biospecimen support, as well as data management, safety surveillance support, and clinical monitoring services for transplant studies, Rho is uniquely well-suited to serve as the T-SCCC. Our objective is to provide excellent service for all activities required per the T-SCCC RFA and to collaborate with NIAID leadership and staff and other NIAID-supported service centers to facilitate efficient provision of all clinical support services for all transplant studies across all the research consortia. To accomplish this objective, Rho will (1) provide leadership and staff with experience in organ transplantation research and the administrative infrastructure needed to manage resources efficiently, to resolve technical and operational issues, and to facilitate effective interaction and collaboration within and between the T-SCCC, investigators, DAIT colleagues, other DAIT-supported service centers, consortia leadership, oversight boards, and regulatory agencies; (2) provide advanced expertise in biostatistics for the efficient design and analysis of observational, interventional, and mechanistic studies in organ transplantation, including analysis of clinical and mechanistic data, preparation of statistical analysis plans in collaboration with investigators and NIAID personnel, and preparation of study reports, presentations, and manuscripts; (3) provide scientific and operational leadership as well as technical and administrative support to enhance communication among study management team members, enable efficient development of protocols and protocol-related documents, expedite study initiation through skillful synchronization of initiation activities, manage oversight of study implementation at the sites, and aid in ensuring proper study conduct and collection of high-quality data; (4) provide experienced staff to determine study needs for biospecimen collection, processing, and shipping; to design study- and visit-specific biospecimen kits as needed; to arrange for procurement of supplies either in bulk or via a web-based supply management system for ordering kits; and to train clinical site personnel on the use of the web-based supply management system; and (5) provide state-of-the-art web-based management systems for tracking the collection, handling, labeling, shipping, storage, disposal, and reporting of biological samples and for the reconciliation of data results corresponding to biological samples and experienced staff to train clinical personnel on the collection and handling of samples and the use of the web-based systems.

项目总结/摘要 通过这一资助机会公告，NIAID正在建立一个移植统计和 临床协调中心（T-SCCC）提供统计设计和分析、研究管理，以及 通过NIAID支持的研究网络为移植研究提供生物标本支持服务， 包括ITN、CTOT和CTOT-CA。作为目前NIAID过敏，免疫学和 移植统计和临床协调中心（DAIT SACC）提供统计设计， 分析、研究管理和生物样本支持，以及数据管理、安全性监督 支持和移植研究的临床监测服务，Rho是唯一适合担任 T-SCCC。我们的目标是为T-SCCC RFA要求的所有活动提供优质服务， 与NIAID领导层和工作人员以及其他NIAID支持的服务中心合作， 为所有研究联盟的所有移植研究提供所有临床支持服务。 为了实现这一目标，Rho将（1）为领导和工作人员提供器官移植方面的经验 有效管理资源所需的研究和行政基础设施，以解决技术和 业务问题，并促进T-SCCC内部和之间的有效互动和协作， 调查人员、DAIT同事、其他DAIT支持的服务中心、联盟领导层、监督委员会， 和监管机构;（2）提供生物统计学方面的先进专业知识，以有效设计和分析 器官移植的观察性、干预性和机制研究，包括临床分析 与研究者和NIAID合作，编制统计分析计划 人员，并准备研究报告，演示文稿和手稿;（3）提供科学和 业务领导以及技术和行政支持，以加强研究之间的沟通 管理团队成员，能够有效制定方案和方案相关文件， 通过熟练同步启动活动加快研究启动，管理研究监督 在研究中心实施，并协助确保正确开展研究和收集高质量数据;（4） 提供经验丰富的工作人员，以确定生物标本采集、处理和运输的研究需求; 根据需要设计研究和访视专用的生物标本试剂盒; 批量或通过基于网络的供应管理系统订购试剂盒;并对临床研究中心工作人员进行 使用网上供应管理系统;以及（5）提供最先进的网上管理 用于跟踪生物制品的收集、处理、贴标签、运输、储存、处置和报告的系统 样品和生物样品对应的数据结果的核对和有经验的工作人员， 培训临床人员如何收集和处理样本，以及如何使用网上系统。