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# ICH Guidance Addendum on Good Clinical Practice
- URL: https://www.fdaweb.com/ich-guidance-addendum-on-good-clinical-practice/
- Published: 2018-02-28T12:00:00.000Z
- Updated: 2026-09-14T23:26:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140865

FDA has posted an International Council for Harmonization [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM464506.pdf?ref=fdaweb.com) on “E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1)” that provides a unified standard for regulatory agencies to allow the mutual acceptance of clinical data. The document amends earlier guidance to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial results. Standardsfor electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated.