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Golden rules for Sponsor: Monitoring

15

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

  • Approvals
  • Training and information
  • Delegation and oversight
  • Informed consent
  • Data handling and source data verification
  • Compliance
  • Facilities, equipment and lab samples
  • Safety reporting
  • Handling of investigational medicinal products
  • Documentations

 

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

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