CTTI Meetings

Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

CTTI Project: Informing the Update of ICH E6

Meeting Location

Virtual Meeting

Meeting Agenda

Meeting Summary

Meeting Materials: 

Day 1

Session I: Introduction/ICH Process & Updating ICH E6 GCP Guidelines 

Session II: CTTI ICH E6 Survey and Stakeholder Input

Session III: Perspectives from EWG Members

Session IV: Perspectives from Clinical Investigators

Session V: Perspectives from Patient Organizations

Day 2

Session I: Stakeholders Perspectives

Session II: Moderated Discussion of Themes from Stakeholders

Session III: Stakeholder Comments

Meeting Overview:

The U.S. Food and Drug Administration, in collaboration with the Clinical Trials Transformation Initiative, is organizing a free two-day Pan-American-focused public web conference on Thursday, June 4, and Friday, June 5, from 10:00 a.m. - 1:00 p.m. EDT, to learn more about stakeholder experiences with the International Council for Harmonisation (ICH) Good Clinical Practice guideline (ICH E6).

This stakeholder engagement web conference will inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Members of the EWG will provide an overview of the ongoing work to update the guideline and will then hear from multiple stakeholders on their experiences with ICH E6(R2). 

The registration process gives registrants an opportunity to submit questions. We will address themes from questions submitted before Tuesday, May 26, during a session on Friday, June 5. Please note the following regarding submissions:

  • Submissions must be in English.
  • Anyone can submit questions or comments. 

Time slots for stakeholders to provide oral comments during the second day of the web conference are now filled. Please consider submitting questions when registering or sending written comments to cttievents@dm.duke.edu (External Link Disclaimer). 

For additional information on the ICH E6 revision efforts, please refer to the following materials: 

Meeting details are available on FDA’s website.