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Implementation Guide for Investigators Updated GCP (E6 R2)

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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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