Administrative Core

行政核心

• 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
• 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

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合会(CPIC)的使命是消除疾病负担 与罕见的儿童病毒性疾病有关，主要是先天性巨细胞病毒(CMV)病，新生儿 单纯疱疹病毒(HSV)感染，新生儿肠道病毒(EV)和副病毒(HPeV)败血症，由 收集多点数据以改进这些罕见疾病的诊断、临床试验准备和治疗。 建议中的筹委会行政架构建基於我们良好的基础设施和成就之上- 成立协作性抗病毒研究小组(CASG)。 CPIC行政核心将为CPIC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)分配和管理人员和 与CPIC活动有关的财务账户，并提供对所有核心和项目的财务监督；2)开发 并执行CPIC场地与研究项目和CPIC核心相关的政策和程序； 3)监督和监控CPIC站点之间的所有内部通信以及与 罕见疾病临床研究网络(RDCRN)数据管理和协调中心(DMCC) 4)评估CPIC整体、研究项目和核心的影响和效果。 我们精心挑选了一个由28个网站组成的联盟，这些网站单独和集体地带来了我们的知识 疾病领域，在制定和实施研究方案方面的合作经验，以及 与他们的患者群体建立密切的伙伴关系。在过去的10年里，所有人都在一起密切合作 几年，在许多情况下长达30年。在这段时间里，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。此协作 形成了长期的合作关系，完善了研究和沟通流程，并 集体了解网站之间的知识差距。我们的团队将由CPIC医学博士David Kimberlin领导 首席调查员(PI)。他将由UAB内的一名项目主任和一名财务经理协助 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。CPIC行政核心将利用一个执行委员会， 包括三位合作伙伴负责人以及国家CMV基金会的一名代表参加， 也就是CPIC利益相关者小组。它将监督研究项目、核心领导力，并将收到 来自外部咨询委员会的建议。