Policy statement of the American Society of Gene Therapy on reporting of patient adverse events in gene therapy trials.
Woo
S L
SL
Institute for Gene Therapy and Molecular Medicine, Mount Sinai School of Medicine, New York, New York 10029, USA. swoo@smtplink.mssm.edu
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