Core--Clinical

University Of Washington, Seattle WA

Investigators

Linked publications & trials

Abstract

The Clinical Core will support investigators of the Program for Excellence in Gene Therapy with the formulation, execution, and analysis of their clinical gene transfer trials, with the goals of ensuring patient safety, facilitating study implementation, and achieving regulatory compliance. During protocol development, the Clinical Core will provide study design, biostatistical, and regulatory support in preparing the clinical protocol. The Clinical Core will assist investigators in preparing submissions to the Institutional Review Board, Institutional Biosafety Committee, General Clinical Research Center, the Recombinant DNA Advisory Committee of the NIH, the FDA, and internal institutional committees. The Core will also assist investigators in preparing their protocols for presentation to the Data and Safety Monitoring Board (DSMB). Prior to implementing the protocol the Clinical Core will play an active role in the preparation of study manuals, case report forms, and related study documents, standard operating procedures related to study conduct, statistical analysis plans, and monitoring plans. During execution of the trial the Clinical Core will provide logistical support for study procedures, specimen collections and processing, and patient travel arrangements. The Clinical Core will facilitate interactions between investigators and the UW General Clinical Research Center and the Gene and Cell Therapy Laboratory. 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 to 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 assure that all trials are conducted strictly in compliance with institutional and governmental regulations. The Clinical Core will also provide ongoing training in Good Clinical Practice, and will assist investigators with submission of adverse event reports and annual reports to the institutional committees, the NIH, and the FDA. Following study completion the Clinical Core will assist with data management and analysis and long-term follow-up.