ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

E6(R3) Document History

Code

History

Date

Approval by the Steering Committee under Step 2 and release for public consultation. Approval by the Steering Committee under Step 4 and recommended for adoption to the three ICH regulatory bodies. Approval by the Steering Committee of Post Step 4 editorial corrections. Adoption by the Regulatory Members of the ICH Assembly under Step 4 . Integrated Addendum to ICH E6(R1) document. Changes are integrated directly into the following sections of the parental Guideline: Introduction, 1.63, 1.64, 1.65, 2.10, 2.13, 4.2.5, 4.2.6, 4.9.0, 5.0, 5.0.1, 5.0.2, 5.0.3, 5.0.4, 5.0.5, 5.0.6, 5.0.7, 5.2.2, 5.5.3 (a), 5.5.3 (b), 5.5.3 (h), 5.18.3, 5.18.6 (e), 5.18.7, 5.20.1, 8.1 Endorsement by the Members of the ICH Assembly under Step 2 and release for public consultation. Endorsement by the Regulatory Members of the ICH Assembly under Step 4.

E6

27 April 1995

E6

1 May 1996

E6(R1)

10 June 1996

E6(R2)

9 November 2016

E6(R3)

19 May 2023

E6(R3)

06 January 2025

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