CORE--CLINICAL OPERATIONS AND REGULATORY AFFAIRS

核心——临床操作和监管事务

• 批准号: 6501592
• 负责人: CHARLEEN HOLLMANN
• 金额: $ 19.94万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-01 至 2002-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6501592
• 关键词: biomedical facility; clinical research; cooperative study; health science research analysis /evaluation; human data

The Clinical Operations and Regulatory Affairs (CORA) Core will provide the Weill Cornell PEGT the infrastructure and expertise to conduct safe and ethical clinical studies in gene therapy. CORA will ensure that all projects follow the regulations and guidelines of the Food and Drug Administration (FDA), NIH Office of Biotechnology Activities/Recombinant DNA Advisory Committee (OBA/RAC), Institutional Review Board (IRB), and Institutional Biosafety Committee (IBC). The CORA Core consists of four interconnected components: Clinical Operations; Monitoring and Quality Assurances; Regulatory Affairs; and Data Management Analysis. The main purpose of Clinical Operations is to oversee day to day conduct of the clinical study at each site including recruiting patients and scheduling visits and tests, collecting data into case report form, handling all correspondence with local regulatory and monitoring agencies and ensuring the protection of the study individuals. The responsibilities of the Monitoring/QA component are central to the CORA, acting to review Clinical Operations both at Weill Cornell and all local sites, collect relevant information to pass on to the Regulatory Affairs component and to provide completed audited data to the Data Management and Analysis Component. Monitoring/QA oversees the general activities of CORA, including all correspondence with federal regulatory and monitoring agencies and ensure compliance of all sites. The Data Management and Analysis component has the responsibility of collecting data from case report forms provided by the Clinical Operations and audited by the Monitoring/QA, entering and analyzing data in conjunction with statisticians, preparing reports to the Regulatory Affairs component in response to request from the Data Safety Monitoring Board, resolving data discrepancies, and preparing periodic data reports. The CORA Core will also participate in the Education Program of the Weill Cornell PEGT, providing training in Clinical Operations and Regulatory Affairs relating to gene therapy.

临床运营和法规事务（CORA）核心将为Weill Cornell PEGT提供基础设施和专业知识，以进行基因治疗的安全和伦理临床研究。CORA将确保所有项目遵循美国食品药品监督管理局（FDA）、NIH生物技术活动办公室/重组DNA咨询委员会（OBA/RAC）、机构审查委员会（IRB）和机构生物安全委员会（IBC）的法规和指南。CORA核心由四个相互关联的部分组成：临床运营;监测和质量保证;法规事务;以及数据管理分析。临床运营部的主要目的是监督各研究中心临床研究的日常开展，包括招募患者、安排访视和检查、将数据收集到病例报告表中、处理与当地监管和监查机构的所有通信，并确保研究人员的保护。监查/QA组件的职责是CORA的核心，负责审查Weill Cornell和所有当地研究中心的临床运营，收集相关信息以传递给法规事务组件，并向数据管理和分析组件提供完整的稽查数据。监查/QA负责监督CORA的一般活动，包括与联邦监管和监查机构的所有通信，并确保所有研究中心的合规性。数据管理和分析部分负责从临床运营部提供的病例报告表中收集数据，并由监查/QA进行稽查，与统计学家一起输入和分析数据，根据数据安全监查委员会的要求编写报告提交给法规事务部分，解决数据差异，并编写定期数据报告。CORA核心还将参与威尔康奈尔PEGT的教育计划，提供与基因治疗相关的临床操作和法规事务培训。