Policy statement of the American Society of Gene Therapy on reporting of patient adverse events in gene therapy trials.
Institute for Gene Therapy and Molecular Medicine, Mount Sinai School of Medicine, New York, New York 10029, USA. swoo@smtplink.mssm.edu
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D002986:Clinical Trials as Topic; D003219:Confidentiality; D015316:Genetic Therapy / Q000009:adverse effects*; D006801:Humans; D009316:National Institutes of Health (U.S.); D011050:Policy Making; D012955:Societies, Medical; D014481:United States; D014486:United States Food and Drug Administration