Clinical core. The Clinical Core will support investigators of the Program for Excellence in Gene Therapy with the formulation, execution and analysis of their clinical gene therapy trials. During protocol formulation the Clinical Core will provide biostatistical support in designing the protocol, as well as advise an active role in the preparation of study manuals, case report forms, regulatory notebooks, statistical analysis plans and monitoring plans. The Clinical Core will assist investigators in preparing their protocols for presentation to the Data Safety Monitoring Board (DSMB) and the Gene Therapy Ethics and Conflict of Interest Board. Prior to beginning the trial an agreement will be set in place which clearly delineates the responsibilities of the study Principal Investigator and the responsibilities of the Clinical Core. During execution of the trial the Clinical Core will provide logistical support for patient travel arrangements, blood draws, sample collections, procedures and other testing. In addition the Clinical Core will verify informed consent, complete case report forms and assist with data management. A key function of the Clinical Core will be in contract with external monitors for each of the clinical protocols to assure that studies are conducted in accordance with the study protocol. A quality assurance auditor will provide oversight of monitoring, will educate staff regarding regulatory requirements, and will assure that all trials are conducted strictly in compliance with institutional and governmental regulations. Following study completion the Clinical Core will assist with data management and analyses.
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