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اقرأ على الانترنت اقرأ أكثر حفظ في قائمتي
  • المؤلفون: Wechsler, Jill
  • المصدر:
    Pharmaceutical Executive. Mar2011, Vol. 31 Issue 3, p12-14. 2p.
  • معلومة اضافية
    • الموضوع:
      MEDICAL records; UNITED States. Food & Drug Administration; HEALTH policy; PATIENTS; HISTORY
    • الموضوع:
      UNITED States
    • نبذة مختصرة :
      The article discusses the Sentinel Initiative of the U.S. Food & Drug Administration (FDA). It states that the initiative leaves the health information of a patient with data holders. It notes that the initiative has established basic principles and policies such as common data model, core safety surveillance methods, and health outcomes of interest (HOIs). It also mentions that Sentinel signals are based from observational data that has limitations in making judgments. INSET: Looking at Liability.