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
Have confidence that you’re ready for successful implementation of the final R3 guidance with Tracking the Revised ICH E6: A Side-by-Side Comparison of Revisions 2 and 3.
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.
Who Will Benefit
- Service providers