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Table 1 Content of training programme for healthcare workers at health facilities

From: Experience of safety monitoring in the context of a prospective observational study of artemether-lumefantrine in rural Tanzania: lessons learned for pharmacovigilance reporting

Topic Content
Study drug (AL) Indications and dosage
  Drug interactions
  Use in pregnancy/lactation
  Common ADRs (frequency > 10%)
  Special precautions
Study objectives Primary and secondary objectives of the observational study (ALIVE)
ADRs, AEs & SAEs Minimum reporting requirements
  Definitions of ADRs, AEs & SAEs (including congenital abnormalities & birth defects)
  Detection and recognition of ADRs, AEs & SAEs
Reporting of AEs & SAEs Data collection requirements
  TFDA reporting form
  Novartis SAE reporting form
  1. ADR = adverse drug reaction; AE = adverse event; AL = artemether-lumefantrine; ALIVE = A rtemether-L umefantrine I n V ulnerable patients: E xploring health impact; SAE = serious adverse event; TFDA = Tanzanian Food and Drugs Authority. ADRs were defined as 'all noxious and unintended responses to a medicinal product related to any dose. The responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility i.e. the relationship cannot be ruled out'