The Front Room — a clinical regulatory commons
RSS
GUIDELINE Step 4 Final

E6(R3) Good Clinical Practice — Step 4 Final Guideline

E6(R3) International Council for Harmonisation
ABSTRACT — EDITORS' SUMMARY

The ICH GCP standard. Overarching principles, Annex 1 (interventional trials), Annex 2 (decentralised and pragmatic elements). The doctrinal source the other authorities adopt and annotate.

EMBEDDED PDF
Page of —
DownloadView on ICH ↗
Loading PDF…
METADATA
TypeGUIDELINE
Year2025
VersionStep 4 Final
StatusCurrent
FormatPDF
Pages104
Size3.1 MB
Last reviewedJAN 2025
SOURCE
PDF · CANONICAL LINK https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106_ErrorCorrections_2025_1024.pdf ↗
RELATED · SAME AUTHORITY
ICH E6(R3) Annex 2
E6(R3) Annex 2 — Non-Traditional Interventional Clinical Trials
GUIDELINE 2025
ICH E20
E20 Adaptive Designs for Clinical Trials
GUIDELINE 2025
ICH E19
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials
GUIDELINE 2022
ICH E14/S7B Q&As
ICH E14/S7B Q&As — Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation
Q&A 2022
ICH E9(R1)
ICH E9(R1) Training Material — Estimands and Sensitivity Analysis in Clinical Trials
Q&A 2021