Golden rules for sponsor: <em>Handling of adverse events</em>


Golden rules contain GCP requirements, best practice and practical examples within:

  • Adverse event form design and receipt
  • Data entry in safety database
  • Serious adverse events
  • Expectedness assessment
  • Causality assessment
  • MedDRA coding
  • Right First Time Narrative
  • Reporting
  • Adverse event follow up
  • Handling of pregnancies


Include examples of inspection findings when the rules were not followed.

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