Overview
Our work to improve the quality and efficiency of clinical trials goes beyond the U.S. borders. Recently, CTTI conducted several efforts to help inform the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as it revises ICH E6 Good Clinical Practice (GCP):
- Through a global, multi-stakeholder survey with 327 research professionals from 154 countries, in-depth interviews, and a public open comment period, CTTI issued a report outlining the areas requiring the most focus pertaining to sponsors, essential documents, and investigators.
- CTTI co-hosted a public event with the FDA to help the ICH in its efforts to improve various topics within GCP.
- CTTI also convened two public web conferences hosted by the ICH that provided an update on the progress to revise this important and impactful guideline.
Solutions
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Resources
Related Items
- Informing the Renovations to the ICH E6 GCP Guideline for Good Clinical Practice Executive Summary
- Stakeholders’ recommendations for revising Good Clinical Practice
- ICH E6 Guideline for Good Clinical Practice – Update on Progress
- Public Web Conference Report: Stakeholder Engagement on ICH E6 Guideline for GCP
- Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
- Findings & Reflections from CTTI’s ICH E6 Renovation Work
- Survey Findings: Informing the Renovations to the ICH E6 GCP Guideline
- Open Comment Findings: Informing the Renovations to the E6 GCP Guideline
- Interview Findings: Informing the Renovations to the ICH E6 GCP Guideline
News
- Report Now Available: ICH E6 Guideline for Good Clinical Practice (GCP) – Update on ProgressThe report of the public web conference on “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” organized by International Council for Harmonisation (ICH) and convened by ...