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财团（CPIC）的任务是消除疾病负担 与罕见的小儿病毒疾病有关，重点是先天性巨细胞病毒（CMV）疾病，新生儿 通过 收集多站点数据以改善诊断，临床试验准备和对这些罕见疾病的治疗。 拟议的CPIC行政结构建立在我们善良的基础设施以及成功的基础上 建立的合作抗病毒研究小组（CASG）。 CPIC行政核心将为操作提供监督，协调和后勤支持 拟议的财团。核心的具体目的是：1）分配和管理人员 与CPIC活动有关的财务帐户，并对所有核心和项目提供财政监督； 2）发展 并实施与研究项目和CPIC核心有关的CPIC网站使用的政策和程序； 3）监督和监视CPIC站点之间的所有内部通信以及与 稀有疾病临床研究网络（RDCRN）数据管理和协调中心（DMCC）；和 4）评估总CPIC，其研究项目及其核心的影响和有效性。 我们仔细选择了一个由28个站点组成的联盟 疾病领域，在研究方案的制定和实施方面合作的经验，以及 与患者人群建立伙伴关系。至少过去10个都密切合作 多年，在许多情况下最多30年。在这段时间内，UAB提供了科学，监管的 所有研究的试验管理，生物统计，实验室和数据管理支持。这项合作 已经建立了长期的关系，研究和沟通过程的完善以及 集体了解站点之间的知识差距。我们的团队将由医学博士David Kimberlin，CPIC领导 首席研究员（PI）。 UAB中的计划主任和财政经理将协助他 中央单位，以确保及时完成全天的行政详细信息，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 包括来自三位合作伙伴的参与，以及国家CMV基金会的代表， 这是CPIC利益相关者组。它将监督研究项目，核心领导，并将获得 外部咨询委员会的建议。