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.
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