RhoFED T-SCCC

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要通过本次资助机会公告，NIAID 正在建立移植统计和临床协调中心 (T-SCCC) 提供统计设计和分析、研究管理和通过 NIAID 支持的研究网络资助的移植研究生物样本支持服务，包括 ITN、CTOT 和 CTOT-CA。目前 NIAID 过敏、免疫学和移植统计和临床协调中心 (DAIT SACCC) 提供统计设计和分析、研究管理和生物样本支持，以及数据管理、安全监测移植研究的支持和临床监测服务，Rho 非常适合作为 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，并与 NIAID 领导层和工作人员以及其他 NIAID 支持的服务中心合作，以促进高效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) 为领导层和员工提供器官移植方面的经验有效管理资源、解决技术和问题所需的研究和行政基础设施运营问题，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、财团领导层、监督委员会、和监管机构； (2) 提供先进的生物统计学专业知识，以高效设计和分析器官移植的观察性、介入性和机制研究，包括临床分析和机械数据，与研究人员和 NIAID 合作制定统计分析计划人员以及研究报告、演示文稿和手稿的准备；（三）提供科学的、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，能够有效开发协议和协议相关文件，通过启动活动的巧妙同步加快研究启动，管理研究监督现场实施，并帮助确保正确的研究进行和高质量数据的收集； (4) 提供经验丰富的工作人员来确定生物样本采集、处理和运输的研究需求；到根据需要设计研究和访问特定的生物样本套件；安排采购物资批量或通过基于网络的供应管理系统订购套件；并对临床现场人员进行培训使用基于网络的供应管理系统； (5) 提供最先进的基于网络的管理用于跟踪生物制品的收集、处理、标签、运输、储存、处置和报告的系统样品和与生物样品相对应的数据结果的协调以及经验丰富的工作人员对临床人员进行样本收集和处理以及网络系统使用方面的培训。