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.