Golden rules for Investigators and Site Staff: <em>Handling of Adverse Events</em>


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

  • Adverse event identification
  • Adverse event diagnosis
  • Assessment of seriousness
  • Assessment of causality
  • Dechallenge and rechallenge
  • Adverse event reporting and timelines
  • Adverse event follow up
  • Handling of pregnancies
  • Medication error, misuse and abuse


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

Albert Einstein:
Success = Work + Play
Successful business = Knowledge + Quality
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