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Regulations/ICH E6(R3)/AI Governance
AI Governance · ICH E6(R3)

AI Governance for ICH E6(R3).

This page focuses on AI governance implications inside regulated work. It shows where AI changes evidence needs while keeping quality, regulatory, data, supplier, and human accountability controls in view.

Source basis: ICH E6(R3) Guideline for Good Clinical PracticeUse: evidence-readinessBoundary: not legal advice
ICH E6(R3) TRACE E6(R3) PRINCIPLESANNEX 1 FINALGLOSSARY/DEFINITQUALITY BY DESIG
/ AI governance

AI changes the evidence pattern, not the need for control.

ICH E6(R3)
Control 01

AI trial tools

Site selection, eligibility, RBQM analytics, ePRO/eCOA, and safety triage should be assessed through participant/data reliability risk.

Control 02

Computerized systems

Validation, access, audit trail, and data governance still govern digital trial tools.

Control 03

Human accountability

Sponsor and investigator responsibilities do not disappear when vendors or AI tools are used.

Control 04

Monitoring signals

Analytics need documented interpretation, escalation, and action routes.

/ Adjacent controls

AI governance must connect to existing regulated systems.

not isolated
Evidence 01

Critical-to-quality factor log

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 02

Risk assessment and mitigation plan

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 03

Protocol quality design rationale

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 04

Sponsor oversight plan

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 05

Vendor/service-provider oversight file

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

Evidence 06

Investigator responsibility evidence

Connect this evidence to QMS, clinical, software, supplier, data, or lifecycle governance where applicable.

/ Source anchors

Current public sources for ICH E6(R3).

official first

These links are the public source anchors for this workspace. Interpretation, checklists, and future assets should point back here before being reused outside iFeed.

Official ICH page

ICH Efficacy Guidelines page

Current · Official landing page for ICH efficacy guidelines including E6(R3).

open
Official guideline PDF

ICH E6(R3) Step 4 final guideline

2025-01-06 · Final Step 4 guideline text for principles and Annex 1.

open
Official EMA page

EMA ICH E6 scientific guideline page

2025-07-23 · EU regional implementation context for ICH E6(R3) Principles and Annex 1.

open
Official ICH draft / watch item

ICH E6(R3) Annex 2 draft

2024-11-06 · Draft Annex 2 source. Treat as watch item, not final implemented requirement.

open