Administrative Core

摘要 肾病综合征研究网络（NEPTUNE）是一个由26个研究中心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转化研究， 肾病综合征（NS）：局灶性和节段性肾小球硬化（FSGS）、微小病变疾病（MCD）， 膜性肾病（Membranous Nephropathy，MN）NEPTUNE行政核心的主要作用是管理 并整合所有的临床和转化研究活动在NEPTUNE网站。它负责 治理、政策和基础设施的整体开发、实施和维护 临床研究、试点和辅助研究计划、职业提升机会所需的，以及 在网络中的推广活动。Kretzler、Sedor、Holzman、Gipson、Gadegbeku和Trachtman博士将 代表联合体领导团队。Kretzler博士将担任联合体的PI。Sedor博士将担任 行政领导，指导日常计划规划，协调和网络评估。Drs. Gadegbeku、马里亚尼、Sedor、Gipson和Trachtman将共同领导这两项纵向临床研究。 Kretzler和Gipson将共同领导精准医学研究。Holzman博士将领导试点/辅助项目， 职业发展方案。Trachtman博士将担任临床研究联络员，这一角色旨在 NEPTUNE III确保跨地点参与网络活动。NephCure Kidney International（NKI） 从患者的角度提供关键的领导输入。海王星指导委员会将 继续作为中央治理结构，由参与研究中心PI的投票成员、患者 倡导团体和NCATS和NIDDK的资助伙伴。联合体将继续分配 小组委员会，以帮助计划，实施和监督影响成功的日常活动， 财团核心组成部分。其他特定任务或专题工作组由联合体提名 在NEPTUNE的使命范围内，各成员应满足具体需求和机会。一个独立 肾小球疾病、精准医学、生物标志物开发和罕见病领域的专家组 疾病研究将成立一个外部咨询委员会，每年审查并就以下问题向网络提供建议： 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 海王星调查员。吉莱斯皮、Zee和Troost博士将领导核心生物统计支持、数据管理， 和良好数据实践（GDP），并确保云就绪数据集可用于罕见疾病社区。贺建 将领导NEPTUNE中通用数据元素的开发工作，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。使用NEPTUNE辅助研究政策， 联合会将在研究合作中建立公私伙伴关系。

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.