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Golden rules for Investigators and Site staff: Trial Conduct

15

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

  • Scientific knowledge (Investigator’s Brochure)
  • IRB/IEC Communication
  • Compliance
  • Oversight
  • Training and qualification
  • Informed consent
  • Facilities and equipment
  • Handling of adverse events
  • Handling of investigational medicinal products
  • Data and records

 

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

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