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Healthcare Professionals
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Healthcare Professionals
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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
Scientific Communication & Interactions – 3 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 + 6 years
Accounting records, data & support documents- 10 years