print_label | resize_label
Who is covered

Patients

  • 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
  • Non-clinical patient information- last date of activity + 3 years
  • Bioanalytical study file (from clinical studies)- life of product + 15 years
  • Retention samples for customer complaint samples- completion of complaint investigations
  • Patient Assistance programs & direct to patient/physician records- 10 years
  • 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