CORE--Clinical Operations and Regulatory Affairs ( CORA )

核心--临床运营和监管事务（CORA）

• 批准号: 8234985
• 负责人: CHARLEEN HOLLMANN
• 金额: $ 23.02万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8234985
• 关键词: Chronic Obstructive Airway Disease; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Data; Data Analyses; Databases; Development; Guidelines; Homeostasis; Injury; Institutional Review Boards; Monitor; Natural regeneration; Office for Human Research Protections; Participant; Play; Procedures; Process; Regulation; Regulatory Affairs; Reporting; Research Infrastructure; Research Personnel; Research Project Grants; Role; Services; Smoking; Statistical Methods; Training; United States Food and Drug Administration; United States National Institutes of Health; data management; operation; research study; skills

The Clinical Operations and Regulatory Affairs (CORA) Core provides the Weill Cornell four COPD SCCOR clinical projects the infrastructure and expertise to conduct clinical research projects that follow the regulations and guidelines of the Food and Drug Administration (FDA), National Institutes of Health (NIH), Institutional Review Board (IRB) and Office for Human Research protections (OHRP). Included in the CORA Core are four components: (1) Clinical Operations; (2) Regulatory Affairs; (3) Monitoring; and (4) Data Management and Analysis. The Clinical Operation component is the major interface of the CORA Core with the study participants and investigators, providing services to carry out the clinical study in compliance with all regulations and guidelines under established standard operating procedures. The Clinical Operation component is also the major interface between the investigators and the local oversight groups, including the IRB and the General Clinical Research Center (GCRC). The Monitoring component functions to verify that all functions of the CORA Core are appropriate. The Data Management and Analysis component processes collected and verified data, enters the data into databases, and analyzes the data using appropriate statistical methods. The Regulatory Affairs component is the interface of the CORA Core with federal agencies for oversight of clinical research studies. In addition the Regulatory Affairs component provides periodic reports to the Weill Cornell Data Safety and Monitoring Board to provide additional oversight to clinical studies. The CORA Core also participates in the Weill Cornell COPD SCCOR Clinical Research Skills Development Core (Core E), providing training in Clinical Operations/Regulatory Affairs. The CORA Core will play an important role in helping the investigators to implement and conduct the four clinical projects. Finally, the CORA Core will play a central role in assisting the investigators in preparing, submitting and getting all regulatory documents to the IRB and the Weill Cornell Data Safety Monitoring Board (DSMB) throughout the yr 01-05 study period.

临床运营和法规事务部（CORA）核心提供了Weill Cornell四项COPD SCCOR临床项目的基础设施和专业知识进行临床研究项目， 遵循美国食品药品监督管理局（FDA）、美国国家研究院 美国卫生部（NIH）、机构审查委员会（IRB）和人类研究保护办公室 （人权高专办）。CORA核心包括四个组成部分：（1）临床运营;（2）监管 （3）管理;（4）数据管理和分析。临床操作组件 是CORA核心与研究参与者和研究者的主要接口，提供 根据以下所有法规和指南开展临床研究的服务 建立了标准操作程序。临床操作部分也是主要的 研究者与当地监督小组（包括IRB和 综合临床研究中心（GCRC）。监控组件的功能是验证所有 CORA核心的功能是适当的。数据管理和分析组件 处理收集和验证的数据，将数据输入数据库，并使用 适当的统计方法。法规事务部分是CORA的接口 与联邦机构合作，监督临床研究。此外，监管 事务组件向威尔康奈尔数据安全和监测委员会提供定期报告， 对临床研究进行额外监督。CORA核心还参加了威尔康奈尔大学 COPD SCCOR临床研究技能发展核心（核心E），提供临床研究技能培训。 运营部/法规事务部。CORA核心将在帮助 研究人员实施和开展四个临床项目。最后，CORA核心将发挥 在协助研究者准备、提交和获取所有监管文件方面发挥核心作用 全年向IRB和Weill Cornell数据安全监测委员会（DSMB）提交文件 01-05研究期间。