Shop

Golden rules for Investigators and Site Staff: Handling of Adverse Events

15

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.

Category:
Albert Einstein:
Success = Work + Play
PharmaGCP:
Successful business = Knowledge + Quality
Get in touch with us
info@pharmagcp.com
We work closely with you and carry out research to understand your needs and wishes.