> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ICH Proposes Revisions to Good Clinical Practice Guidelines
- URL: https://www.fdaweb.com/ich-proposes-revisions-to-good-clinical-practice-guidelines/
- Published: 2017-01-13T12:00:00.000Z
- Updated: 2026-09-14T22:00:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137727

The International Council for Harmonization (ICH) is looking to “renovate” its guidelines on good clinical practice. A new white paper from the group entitled “[ICH Reflection on ‘GCP Renovation’: Modernization of ICH E8 and Subsequent Renovation of ICH E6”](http://www.ich.org/fileadmin/Public%5FWeb%5FSite/ICH%5FProducts/GCP%5FRenovation/ICH%5FReflection%5Fpaper%5FGCP%5FRenovation%5FJan%5F2017%5FFinal.pdf?ref=fdaweb.com) outlines an approach to update guidelines on clinical trial design, planning, management, and conduct. Revisions to *E8 General Considerations for Clinical Trials* and the *E6 Guideline for Good Clinical Practice* are needed to “address the increasing diversity of clinical trial designs and data sources that are being employed to support regulatory and other health policy decisions,” ICH says.

The revisions are intended to address stakeholder concerns that the current ICH E6 guideline “fails to sufficiently recognize variations in the level of risk for participants in different types of trials and allow corresponding flexibility in managing the risks,” the group says. Another major concern to be tackled is that the guideline should “more holistically address the planning and conduct of clinical trials,” it adds.

The white paper proposes to revise ICH E8 to recognize that data quality fundamentally depends on the quality of the study that generates the data, and that many aspects of study design affect the reliability of the study conclusions. “The proposed revision would include a well-organized and fairly comprehensive review of the issues and questions that are most critical to clinical trial quality,” it says. “This may include critical-to-quality factors that should be considered by sponsors when planning a study.”

  
On good clinical practice revisions, the white paper proposes to address flexibility concerns that anticipates and addresses a broader range of study types and data sources. ICH will look to discuss the “range of regulatory and other health research questions that need to be addressed, and data sources in addition to traditional interventional trials that might be used to address them,” it says. The paper also proposes to revise the guideline to “enhance its utility in supporting clinical trial design and planning for data quality” and encourage risk-based approaches to site monitoring.