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International transfers

Healthcare Professionals

  • Adverse event reports- life of product + 15 years
  • Records of meetings with external groups - 10 years
  • Records of non-personal promotional history to consumers and healthcare professionals- active life
  • Investigator site file- completion of study + 15 years
  • Study Master file- life of product + 15 years
  • Non-Interventional study file- after last subject visit + 5 years
  • Call report & non-US sales distribution- 3 years
  • Healthcare Professional payments & items of value disclosure & reporting- 10 years
  • Patient Assistance programs & direct to patient/physician records- 10 years
  • Compliance Investigations- end of investigation + 6 years
  • Litigation & claim files- end of litigation or claim + 10 years
  • Accounting records, data & support documents- 10 years