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The Genetic Modification Clinical Research Information System (GeMCRIS), a web-based data system designed to assist researchers and others involved in human gene therapy studies, manages information about science and safety of clinical trials in this field. Three years in development, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) jointly launched GeMCRIS at the end of March.
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For clinical trials administrators and investigators who desire best practices in human subjects protection, there can be no better place to start than with research staff education. Education and training of research staff and investigators traditionally was provided in the form of a mentoring program in which a junior person learned from a senior person, says Ruth Fischbach, PhD, MPE, director of the Center for Bioethics at Columbia University in New York City.
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During a presentation at the 2004 Annual Scientific Congress of the Royal Australasian College of Surgeons, held May 2-7 in Melbourne, Australia, Jonathan Lewis, MD, PhD, a former cancer researcher at Memorial Sloan-Kettering Cancer Center in New York City and the New Haven, CT-based Yale University School of Medicine, called for changes in oncology clinical trial design.
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Sometimes, the best teaching strategy is one in which the student is not even aware that he or she is a student. At least thats the approach that one research educational program has tried and found to be successful. What I find useful in these situations is to try to recruit investigators to be instructors, says Ruth Fischbach, PhD, MPE, director of the Center for Bioethics at Columbia University in New York City.
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