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Book: Tracking the Revised ICH E6

A Side-by-Side Comparison of Revisions 2 and 3


Changes to the international guideline for good clinical practice, ICH E6, are extensive, significant and scheduled to take effect in less than a year. Are you prepared to understand and implement them?

ICH E6(R3), as currently published, is a completely revised guideline with no reference to the previous version, E6(R2). There is no red-lined version of the guidance available for easy identification of removed, changed, or newly added language.

Tracking the Revised ICH E6: A Side-by-Side Comparison of Revisions 2 and 3 clearly explains the updates by comparing the old language from ICH E6(R2) side-by-side with the new language in ICH E6(R3) and mapping out the completely reorganized guideline. The report is a must-read for investigators, sponsors, IRBs, IECs, service providers — anyone who needs to understand and follow the evolving principles of good clinical practice.


Key changes in ICH E6(R3) include:

  • New and revised principles of GCP
  • Expanded investigator oversight responsibilities
  • Expanded sponsor oversight responsibilities
  • A new section on Data Governance
  • A revised Essential Documents (Records) section


Who will benefit:

  • IRBs/IECs
  • Sponsors
  • Service providers
  • Investigators


Have confidence that you’re ready for successful implementation of the final R3 guidance with this resource!

Learn more

Available now from CenterWatch

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If you are a current member of the Avoca Quality Consortium, this online resource is available to you in the AQC Knowledge Center!
Contact us with access questions or inquiries about joining the AQC.


About the Contributor

Karen Harvey has 25 years of experience in healthcare and in the clinical research industry, including work as a Registered Nurse and in diverse roles within the clinical research industry at the site level and at CROs. She is well-versed in quality assurance and quality management oversight, with a focus on sponsor/CRO oversight and strategic relationships. As the senior director of the Avoca Quality Consortium, part of Avoca, A WCG Company, Harvey has a focus on building strong client relationships, content creation, and expanding client knowledge of WCG solutions.