Administrative Core

摘要 肾病综合征研究网络(海王星)是一个由26个站点组成的合作研究基础设施 在北美开展罕见肾脏疾病的临床和翻译研究 肾病综合征(NS)：局灶性和节段性肾小球硬化(FSGS)、微小病变(MCD)、 膜性肾病(MN)。海王星管理核心起着管理的主要作用 并整合海王星网站的所有临床和翻译研究活动。它负责 治理、政策和基础设施的总体开发、实施和维护 临床研究、先导和辅助研究计划、职业发展机会以及 网络中的外联活动。Kretzler、Sedor、Holzman、Gipson、Gades beku和Trachtman博士将 代表财团领导班子。Kretzler博士将担任该财团的PI。塞多博士将担任 行政领导，指导网络的日常计划规划、协调和评估。戴维斯博士。 加德贝库、玛丽亚尼、塞多尔、吉普森和特拉赫特曼将共同领导这两项纵向临床研究。 Kretzler和Gipson将共同领导精密医学研究。霍尔兹曼博士将领导飞行员/辅助人员和 职业提升计划。Trachtman博士将担任临床研究联络人，这一角色设计在 海王星III，以确保跨站点参与网络活动。NephCure肾脏国际(NKI)将 从患者的角度提供关键的领导意见。海王星指导委员会将 继续作为中央治理结构，由参与站点PI、Patient的投票成员组成 倡导团体，以及NCATS和NIDDK的资金合作伙伴。该财团将继续转让 小组委员会，以帮助规划、实施和监测影响 财团核心组件。其他特定于任务或专题的工作组由财团提名 成员解决海王星使命范围内的具体需求和机会。无党派人士 肾小球疾病、精确医学、生物标记物开发和稀有领域的专家组 疾病研究将组成一个外部咨询委员会，并将每年审查该网络并就以下问题提供建议 它的科学进步。临床方案将由OSMB监督，以监测研究工作并提供建议 海王星调查人员。吉莱斯皮、齐和特罗斯特博士将领导核心生物统计支持、数据管理、 和良好的数据实践(GDP)，并确保云就绪数据集可用于罕见病社区。何博士 将领导开发海王星通用数据元素的工作，并与KPMP和其他相关项目保持一致 具有相同的基于社区的综合本体论。利用海王星辅助研究政策， 财团将在研究合作中建立公私合作伙伴关系。

ABSTRACT The Nephrotic Syndrome Study Network (NEPTUNE) is a collaborative investigational infrastructure of 26 sites across North America for conducting clinical and translational research on rare kidney diseases presenting as Nephrotic Syndrome (NS): Focal and Segmental Glomerular Sclerosis (FSGS), Minimal Change Disease (MCD), and Membranous Nephropathy (MN). The NEPTUNE Administrative Core serves the primary role to manage and integrate all activities for clinical and translational research across the NEPTUNE sites. It is responsible for the overall development, implementation, and maintenance of the governance, policies, and infrastructure required for the clinical studies, pilot and ancillary studies program, career enhancement opportunities, and outreach activities in the network. Drs. Kretzler, Sedor, Holzman, Gipson, Gadegbeku, and Trachtman will represent the consortium leadership team. Dr. Kretzler will serve as PI of the consortium. Dr. Sedor will serve as Administrative Lead, directing day-to-day program planning, coordination, and evaluation of the network. Drs. Gadegbeku, Mariani, Sedor, Gipson, and Trachtman will co-lead the two longitudinal clinical studies, and Drs. Kretzler and Gipson will co-lead the Precision Medicine Study. Dr. Holzman will lead the Pilot/Ancillary and Career Enhancement Programs. Dr. Trachtman will serve as the Clinical Study Liaison, a role designed in NEPTUNE III to ensure cross-site engagement in Network activities. NephCure Kidney International (NKI) will provide critical leadership input from the patient perspective. The NEPTUNE Steering Committee (SC) will continue to be the central governance structure, consisting of voting members of the participating site PIs, patient advocacy groups, and funding partners at NCATS and NIDDK. The consortium will continue to assign subcommittees to help plan, implement, and monitor day-to-day activities that impact the success of the consortium core components. Additional task- or topic-specific working groups are nominated by consortium members to address specific needs and opportunities in the scope of NEPTUNE's mission. An independent group of experts in the areas of glomerular disease, precision medicine, biomarker development, and rare disease research will form an External Advisory Committee and will annually review and advise the Network on its scientific progress. Clinical protocols will be overseen by an OSMB to monitor research efforts and advise NEPTUNE investigators. Drs. Gillespie, Zee, and Troost will lead core biostatistical support, data management, and good data practices (GDP), and ensure cloud-ready datasets for use in the rare disease community. Dr. He will lead efforts to develop Common Data Elements in NEPTUNE and align with KPMP and other related projects with the same community-based integrative ontologies. Using the NEPTUNE Ancillary Study Policy, the consortium will engage public-private partnerships in research collaborations.