Administrative Core

行政核心

• 批准号: 10481858
• 负责人: Cary O. Harding
• 金额: $ 18.76万
• 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/10481858
• 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. 项目概要——行政核心 行政核心将负责俄勒冈州运营的整体管理。 健康与科学大学将成为该联盟的协调中心。 监督联合体的财务，制定联合体的所有政策和程序，维护 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 (ORDR) (NICHD) 管理核心将负责联盟之间的数据管理。 数据管理协调中心（DMCC）的站点，还将负责研究设计 核心人员将负责整个部门的监管合规性。 联盟包括 IRB 协议的准备和提交以及数据安全监控的开发 计划。