CORE--CLINICAL OPERATIONS AND REGULATORY AFFAIRS

临床操作和监管事务（CORA）核心将为威尔康奈尔PEGT提供基础设施和专业知识，以进行安全和合乎伦理的基因治疗临床研究。CORA将确保所有项目遵循美国食品和药物管理局（FDA）、美国国立卫生研究院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）的规定和指导方针。CORA核心由四个相互关联的部分组成：临床操作；监测和质量保证；监管事务;和数据管理分析。临床操作的主要目的是监督每个地点临床研究的日常开展，包括招募患者和安排访问和测试，收集病例报告表格中的数据，处理与当地监管和监测机构的所有通信，并确保对研究人员的保护。监测/质量保证部分的职责是CORA的核心，负责审查威尔康奈尔和所有当地站点的临床操作，收集相关信息传递给法规事务部分，并向数据管理和分析部分提供完整的审计数据。监控/QA监督CORA的一般活动，包括与联邦监管和监控机构的所有通信，并确保所有站点的合规性。数据管理和分析部分负责从临床操作提供的病例报告表格中收集数据，并由监测/QA审核，与统计人员一起输入和分析数据，根据数据安全监测委员会的要求向监管事务部分准备报告，解决数据差异，并准备定期数据报告。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监管事务方面的培训。

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.