CORE--CLINICAL OPERATIONS AND REGULATORY AFFAIRS

临床操作和监管事务(CORA)核心将为威尔·康奈尔大学PEGT提供基础设施和专业知识，以进行安全和合乎道德的基因治疗临床研究。CORA将确保所有项目遵循食品和药物管理局(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)的法规和指导方针。CORA核心由四个相互关联的部分组成：临床业务；监测和质量保证；监管事务；以及数据管理分析。临床业务的主要目的是监督每个地点的临床研究的日常进行，包括招募患者和安排访问和测试，将数据收集到病例报告表格中，处理与当地监管和监测机构的所有通信，并确保研究人员的保护。监测/质量保证部门的职责是CORA的核心职责，负责审查威尔康奈尔大学和所有地方办事处的临床业务，收集相关信息以转交监管事务部门，并向数据管理和分析部门提供完整的经审计数据。监测/质量保证监督CORA的一般活动，包括与联邦监管和监测机构的所有通信，并确保所有地点的合规性。数据管理和分析部门负责从临床业务部门提供并由监测/质量保证部门审计的病例报告表中收集数据，与统计员一起输入和分析数据，应数据安全监测委员会的要求编写提交监管事务部门的报告，解决数据差异问题，并编写定期数据报告。CORA CORE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.