COO Tammy Finnegan takes a first read-out of the proposed changes to the guidance
At the end of 2019, the ICH Management Committee endorsed the business plan and scope for ICH E6 R3. A complete re-write of E6 is being proposed, focusing on two areas: Appendix 1 - Interventional Trials; and Appendix 2 – Non-Interventional Trials.
The draft technical document for Appendix 1 is expected to take 18 months to write and they are forecasting Q2 2021 for completion. The revisions will include the focus on critical to quality factors (building on the anticipated E8 R1), the use of technology and more varied data sources in clinical trial design and conduct.
To read the full R3 concept paper, please follow this link https://bit.ly/3abw519