Administrative Core

行政核心

基本信息

批准号：
10465117
负责人：
DAVID W KIMBERLIN
金额：
$ 11.97万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-09-01 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10465117
关键词：
Advisory Committees Area Biometry Childhood Clinical Research Clinical Trials Collaborations Communicable Diseases Communication Congenital herpes simplex Cytomegalovirus Data Data Coordinating Center Development Diagnosis Disease Effectiveness Elements Ensure Enterovirus Feedback Foundations Future Heart Herpes Simplex Infections Human Individual Infrastructure Knowledge Laboratories Leadership Mission Modeling Monitor Neonatal Parechovirus Perinatal Infection Personnel Management Policies Population Principal Investigator Procedures Process Protocols documentation Publishing Rare Diseases Research Research Personnel Research Project Grants Resources Sepsis Site Structure Time Training Viral Virus Diseases Work biomarker evaluation burden of illness career clinical trial readiness congenital cytomegalovirus congenital infection data management experience improved innovation operation patient population pediatric department pharmacometrics programs skills success trial design

项目摘要

The mission of the Congenital and Perinatal Infections Consortium (CPIC) is to eliminate the disease burden associated with rare pediatric viral diseases, focusing on congenital cytomegalovirus (CMV) disease, neonatal herpes simplex virus (HSV) infection, and neonatal enterovirus (EV) and parechovirus (HPeV) sepsis, by gathering multi-site data to improve diagnosis, clinical trial readiness, and treatment of these rare diseases. The proposed CPIC administrative structure builds on the infrastructure, as well as the success, of our well- established Collaborative Antiviral Study Group (CASG). The CPIC Administrative Core will provide oversight, coordination, and logistical support for the operation of the proposed Consortium. The specific aims of the Core are to: 1) allocate and manage personnel and the financial accounts related to CPIC activities, and provide fiscal oversight of all cores and projects; 2) develop and implement policies and procedures to be used by CPIC sites related to research projects and CPIC Cores; 3) oversee and monitor all internal communication between CPIC sites and external communication with the Rare Diseases Clinical Research Network (RDCRN) Data Management and Coordinating Center (DMCC); and 4) evaluate the impact and effectiveness of the overall CPIC, its research projects, and its cores. We have carefully selected a coalition of 28 sites that individually and collectively bring knowledge of our disease areas, experience collaborating on the development and implementation of research protocols, and close partnerships with their patient populations. All have worked closely together for at least the past 10 years, and in many cases for up to 30 years. Throughout that time, UAB has provided scientific, regulatory, trial management, biostatistical, laboratory, and data management support for all studies. This collaboration has resulted in long-standing relationships, refinement of research and communication processes, and a collective understanding of knowledge gaps among sites. Our team will be led by David Kimberlin, MD, CPIC Principal Investigator (PI). He will be assisted by a Program Director and a Fiscal Manager within the UAB Central Unit to ensure timely completion of all day-to-day administrative details, including regulatory coordination and budgetary matters. The CPIC Administrative Core will utilize an Executive Committee that includes participation from three partner leads, as well as a representative from the National CMV Foundation, which is the CPIC Stakeholder Group. It will oversee research projects, Core Leadership, and will receive advice from an External Advisory Committee.

先天性和围产期感染联盟 (CPIC) 的使命是消除疾病负担与罕见的儿科病毒性疾病相关，重点关注先天性巨细胞病毒 (CMV) 疾病、新生儿单纯疱疹病毒 (HSV) 感染、新生儿肠道病毒 (EV) 和副肠病毒 (HPeV) 败血症收集多站点数据以改善这些罕见疾病的诊断、临床试验准备和治疗。拟议的 CPIC 行政架构建立在我们良好的基础设施和成功之上。成立抗病毒合作研究组（CASG）。太保行政核心将为太保的运作提供监督、协调和后勤支持。拟议的财团。核心的具体目标是： 1）分配和管理人员以及与太保活动相关的财务账户，并对所有核心和项目提供财政监督； 2）开发实施 CPIC 站点使用的与研究项目和 CPIC 核心相关的政策和程序； 3) 监督和监控CPIC各站点之间的所有内部通信以及与CPIC的外部通信罕见病临床研究网络（RDCRN）数据管理和协调中心（DMCC）；和 4）评估整个CPIC、其研究项目及其核心的影响和有效性。我们精心挑选了 28 个站点组成的联盟，这些站点分别或集体地传播我们的知识疾病领域、在研究方案的制定和实施方面的合作经验，以及与患者群体建立密切的伙伴关系。至少在过去 10 年里，所有人都密切合作年，在许多情况下长达 30 年。在此期间，UAB 提供了科学、监管、为所有研究提供试验管理、生物统计、实验室和数据管理支持。此次合作建立了长期的关系、研究和沟通过程的完善以及对站点之间知识差距的集体理解。我们的团队将由 CPIC 董事总经理 David Kimberlin 领导首席研究员（PI）。他将得到 UAB 内一名项目总监和一名财务经理的协助中央单位确保及时完成所有日常行政细节，包括监管协调和预算事项。太保行政核心将设立一个执行委员会，包括三位合作伙伴领导以及来自国家 CMV 基金会的代表的参与，即太保利益相关方团体。它将监督研究项目、核心领导力，并将接收外部咨询委员会的建议。