Administrative Core

行政核心

• 批准号: 10260443
• 负责人: Cary O. Harding
• 金额: $ 19.98万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-16 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10260443
• 关键词: Advocacy; Biometry; Clinical Research; Communication; Data; Data Analyses; Disease; Health Sciences; Human Resources; Hyperphenylalaninaemias; Institutional Review Boards; Monitor; National Institute of Child Health and Human Development; Oregon; Policies; Preparation; Procedures; Rare Diseases; Research; Research Design; Safety; Site; Structure; Universities; clinical research site; data management; operation; protocol development

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.

2.项目摘要-行政核心 行政核心将负责联合体业务的全面管理。俄勒冈州 健康与科学大学将为该联盟提供协调中心。行政核心将 监督联合体的财务，建立联合体的所有政策和程序， 联盟中的临床研究中心与我们的倡导小组合作伙伴之间的沟通 NPKUA，并与罕见病临床研究网络（RDCRN）和 国家儿童健康和人类发展研究所罕见疾病研究办公室（ORR） （NICHD）。行政核心将负责管理联合体之间的数据 数据管理协调中心（DMCC），还将负责研究设计 和数据的生物统计学分析。核心人员将负责 联合体，包括IRB方案的编制和提交以及数据安全性监测的开发 布局