Administrative Core

2.项目总结--行政核心 行政核心将负责财团业务的全面管理。俄勒冈州 健康与科学大学将是该财团的协调中心。行政核心意志 监督财团的财务，制定财团的所有政策和程序，维护 联盟中的临床研究站点与我们的倡导团体合作伙伴之间的沟通 NPKUA，并与罕见疾病临床研究网络(RDCRN)和 美国国家儿童健康与人类发展研究所罕见病研究办公室 (NICHD)。行政核心将负责管理财团之间的数据 向数据管理协调中心(DMCC)移交站点，并负责研究设计 并对数据进行生物统计分析。核心人员将负责整个 联合体，包括准备和提交IRB协议以及开发数据安全监测 计划。

2. PROJECT SUMMARY – ADMINISTRATIVE CORE The Administrative Core will be responsible for the overall administration of Consortium operations. Oregon Health & Science University will house the coordinating center for the consortium. The Administrative Core will oversee the finances of the consortium, establish all policies and procedures of the consortium, maintain communication between the clinical research sites in the consortium and our advocacy group partner the NPKUA, and maintain communication with the Rare Disease Clinical Research Network (RDCRN) and the Office of Rare Diseases Research (ORDR) at the National Institute of Child Health and Human Development (NICHD). The Administrative Core will be responsible for the management of data between the consortium sites to the Data Management Coordinating Center (DMCC) and will also be responsible for the study design and biostatistical analysis of the data. Core personnel will be responsible for regulatory compliance across the consortium including preparation and submission of IRB protocols and development of Data Safety Monitoring Plans.