Administration and Clinical Regulatory Affairs

行政和临床监管事务

• 批准号: 8651522
• 负责人: George Stamatoyannopoulos
• 金额: $ 20.89万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2017-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8651522
• 关键词: Advisory Committees; Animal Welfare; Clinical; Communication; Evaluation; Greek; Hemoglobinopathies; National Heart, Lung, and Blood Institute; New York; Preparation; Principal Investigator; Regulatory Affairs; Reporting; Research Activity; Research Personnel; Services; Stem cells; Teleconferences; United States National Institutes of Health; gene therapy; meetings; programs

The functions of Core Unit A are as follows: 1) To provide all the administrative and fiscal services that are required for support of the research activities of the Projects and the Core Units; 2) To coordinate all the clinical regulatory activities of all the components of the Program Project; 3) To interact with US Federal, Greek, EU and local regulatory agencies, as required; 4) To organize all the communications between components of the Program Project; 5) To coordinate and support the activities of the Internal and External Advisory committees 6) To organize and coordinate the scholarly activities of the Program Project including biweekly teleconference-lab meetings of the Seattle-New York-Thessaloniki investigators, 7) To organize the bimonthly evaluation and planning meetings of the executive committee of the Program Project. 8) To coordinate the fulfillment by all components of the Program Project of administrative requirements concerning biosafety, animal welfare etc 9) To assist the Principal Investigator in preparation of reports to NIH, the NHLBI DSMB and other agencies, as required.

核心单元A的功能如下： 1) 提供支持研究所需的所有行政和财政服务 项目和核心单位的活动； 2) 协调计划项目所有组成部分的所有临床监管活动； 3) 根据需要与美国联邦、希腊、欧盟和当地监管机构互动； 4) 组织计划项目各组成部分之间的所有通信； 5) 协调和支持内部和外部咨询委员会的活动 6) 组织和协调本项目的学术活动，包括每两周一次的学术活动 西雅图-纽约-塞萨洛尼基调查人员的电话会议实验室会议， 7) 组织项目执行委员会每两个月召开一次评估和规划会议 项目。 8) 协调计划项目所有组成部分对行政要求的履行 涉及生物安全、动物福利等 9) 协助首席研究员准备向 NIH、NHLBI DSMB 和其他机构提交的报告 机构，根据需要。