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GUIDELINE Draft Step 2 (under finalisation)

E6(R3) Annex 2 — Non-Traditional Interventional Clinical Trials

E6(R3) Annex 2 International Council for Harmonisation
ABSTRACT — EDITORS' SUMMARY

GCP considerations for pragmatic trials, decentralised trials, and trials incorporating real-world data sources. Public consultation closed late 2025; finalisation expected 2026.

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METADATA
TypeGUIDELINE
Year2025
VersionStep 2 (under finalisation)
StatusDraft
FormatPDF
Pages—
Size—
Last reviewedNOV 2025
SOURCE
PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-e6r3-guideline-good-clinical-practice-annex-2-step-2b_en.pdf ↗
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