M.Pharm Semester 2 · Pharmacology: Clinical Research and Pharmacovigilance notes. Clinical Research and Pharmacovigilance connects study conduct with the collection and review of safety information. Follow the information from its source to a documented assessment.

What to revise

  • Studies: organise trial design, ethics and documentation.
  • Safety reports: distinguish an event, suspected reaction and signal.
  • Systems: connect data review, reporting and communication responsibilities.

A quick self-check

Trace a fictional safety observation through recording, clarification and review. Identify what remains uncertain rather than declaring causality from one report.

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