Implementation Guide for Investigators Updated GCP (E6 R2)


The guide contains all changes in ICH GCP Addendum E6 (R2) with greatest impact on the investigator and recommendations on how to implement these changes:

  • Addendum to chapter 2: The principles of ICH GCP
  • Addendum to chapter 4: Investigator – What is adequate supervision of the conduct of an ongoing clinical trial?
  • Addendum to chapter 4.9: Records and reports
  • Addendum to chapter 1: Glossary_Certified copy
  • Addendum to chapter 5: Monitoring
  • Addendum to chapter 5: Noncompliance
  • Addendum chapter 8: Essential documents
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