Analysis of Medical Data to Determine Adverse Fetal or Neonatal Effects Associated with Drug Use during Pregnancy (English)

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The report summarizes research which includes the establishment of an intensive pediatric drug surveillance program on selected wards at the Children's Hospital Medical Center (and an affiliated hospital), the development of appropriate computer files for the storage, retrieval and analysis of the collected data, and the initial analyses of patterns of drug use and adverse reactions among hospitalized children. From the initiation of funding in June 1974 until the initiation of patient monitoring in September 1974, considerable attention was devoted to the development of data abstraction forms and a training manual that would be appropriate for monitoring pediatric populations. Based on the data forms and manual developed by the Boston Collaborative Drug Surveillance Program for monitoring adult populations, the pediatric counterparts were reviewed in detail for pediatric application, and reflected input from detailed interviews with senior clinical faculty members of the Children's Hospital Medical Center.