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Implementation guide for Sponsors <em>Updated GCP (E6 R2) </em>

35€

The guide contains all changes from ICH GCP Addendum with greatest impact on the sponsor and recommendations on how to implement these changes:

  • Addendum to chapter 2: THE PRINCIPLES OF ICH GCP
  • Addendum to chapter 4: INVESTIGATOR
  • Addendum to chapter 5: SPONSOR – Quality Management
  • Addendum to chapter 5: SPONSOR – Risk-based monitoring (5.18)
  • Addendum to chapter 5: SPONSOR – Noncompliance (5.20)
  • Addendum to chapter 4.9: Records and reports
  • Addendum to chapter 5.5.3: Electronic data handling and use of computerised systems
  • Addendum to chapter 5.2.2: Contract Research Organization (CRO)
  • Addendum chapter 8: Essential documents
  • Addendum to chapter 1: Glossary
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