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


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
Reviews (0)


There are no reviews yet.

Be the first to review “Implementation guide for Sponsors Updated GCP (E6 R2)

Your email address will not be published. Required fields are marked *

Albert Einstein:
Success = Work + Play
Successful business = Knowledge + Quality
Get in touch with us
We work closely with you and carry out research to understand your needs and wishes.