ICH E6(R3) - Good Clinical Practice
ICH E6(R3) Good Clinical Practice (GCP) is the international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The R3 revision (adopted 2023) modernizes GCP for technology-enabled clinical trials, introduces a quality-by-design approach, and addresses decentralized trials, electronic data, and risk-proportionate monitoring.
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Framework Domains (23)
Access Control
| Code | Title |
|---|---|
| E6R3-ANNEX1-ACCESS | Access Control and Segregation of Duties |
Annex 1 - Data Governance
| Code | Title |
|---|---|
| E6R3-A1.10 | Electronic Systems and Records |
| E6R3-A1.9 | Data Governance Framework |
Annex 1 - IRB/IEC Responsibilities
| Code | Title |
|---|---|
| E6R3-A1.1 | IRB/IEC Composition and Functions |
| E6R3-A1.2 | Review Process |
Annex 1 - Investigator Responsibilities
| Code | Title |
|---|---|
| E6R3-A1.3 | Investigator Qualifications and Resources |
| E6R3-A1.4 | Informed Consent |
| E6R3-A1.5 | Investigator Recordkeeping |
Annex 1 - Sponsor Responsibilities
| Code | Title |
|---|---|
| E6R3-A1.6 | Quality Management System |
| E6R3-A1.7 | Risk-Based Monitoring |
| E6R3-A1.8 | Safety Reporting |
Annex 2 - Non-Traditional Interventional Clinical Trials
| Code | Title |
|---|---|
| E6R3-A2.1 | Decentralized Trials |
| E6R3-A2.2 | Adaptive and Platform Trials |
Audit Trail
| Code | Title |
|---|---|
| E6R3-ANNEX1-AUDIT | Audit Trail Risk Based Review |
Computerised Systems
| Code | Title |
|---|---|
| E6R3-ANNEX1-CSV | Validation Proportionate to Use |
Data Governance
| Code | Title |
|---|---|
| E6R3-3.16 | Computerised Systems and Data Governance |
Data Integrity
| Code | Title |
|---|---|
| E6R3-3.17 | Data Integrity ALCOA+ Maintained |
Data Management
| Code | Title |
|---|---|
| E6R3-3.20 | Data Capture and Source Data |
Investigator
| Code | Title |
|---|---|
| E6R3-2.4 | Investigator Oversight Broadened |
| E6R3-2.6 | Informed Consent and Participant Communication |
Lifecycle
| Code | Title |
|---|---|
| E6R3-ANNEX1-MIGRATION | Data Migration and System Retirement |
Monitoring
| Code | Title |
|---|---|
| E6R3-3.25 | Monitoring Approach Flexibility |
Overarching Principles
| Code | Title |
|---|---|
| E6R3-P1 | Participant Protection |
| E6R3-P2 | Risk Proportionality |
| E6R3-P3 | Roles and Responsibilities |
| E6R3-P4 | Quality by Design |
| E6R3-P5 | Data Integrity and Reliability |
Principles
| Code | Title |
|---|---|
| E6R3-PRIN-1 | Subject Rights Safety and Wellbeing |
| E6R3-PRIN-2 | Scientific Soundness and Quality by Design |
| E6R3-PRIN-3 | Proportionate Risk-Based Approach |
| E6R3-PRIN-7 | Roles and Responsibilities Documented |
Quality Management
AS&D quality system requirements
Records
| Code | Title |
|---|---|
| E6R3-4.7 | Essential Records Concept |
Reporting
| Code | Title |
|---|---|
| E6R3-CSR | Clinical Study Report Integrity |
Safety
| Code | Title |
|---|---|
| E6R3-3.30 | Safety Reporting Responsibility |
Signatures
| Code | Title |
|---|---|
| E6R3-ANNEX1-ESIG | Electronic Signatures |
Sponsor
| Code | Title |
|---|---|
| E6R3-3.10 | Sponsor Quality Management |
| E6R3-3.11 | Risk Based Quality Management |
| E6R3-3.12 | Service Provider Management |
Trial Design
| Code | Title |
|---|---|
| E6R3-3.18 | Decentralised and Hybrid Trial Elements |
Your Compliance Coverage
If you comply with ICH E6(R3) - Good Clinical Practice, you already cover:
Aged Care Quality Standards (Australia)
13%
5 controls mapped
Compare →ICH Q10 - Pharmaceutical Quality System
13%
5 controls mapped
Compare →EU Medical Devices Regulation (MDR 2017/745)
13%
5 controls mapped
Compare →+ 495 more: ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence (13%), NYDFS Cybersecurity Regulation (23 NYCRR Part 500) (13%)
See all 498 mapped frameworks ↓Maps to 498 other frameworks
Frequently Asked Questions
What is ICH E6(R3) - Good Clinical Practice?
ICH E6(R3) - Good Clinical Practice is a compliance framework from International (ICH) with 23 domains and 39 controls. ICH E6(R3) Good Clinical Practice (GCP) is the international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. The R3 revision (adopted 2023) modernizes GCP for technology-enabled clinical trials, introduces a quality-by-design approach, and addresses decentralized trials, electronic data, and risk-proportionate monitoring. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does ICH E6(R3) - Good Clinical Practice have?
ICH E6(R3) - Good Clinical Practice has 39 controls organised across 23 domains. The largest domains are Overarching Principles (5 controls), Principles (4 controls), Annex 1 - Investigator Responsibilities (3 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does ICH E6(R3) - Good Clinical Practice map to?
ICH E6(R3) - Good Clinical Practice maps to 498 other compliance frameworks. The top mapping partners are Aged Care Quality Standards (Australia) (13% coverage), ICH Q10 - Pharmaceutical Quality System (13% coverage), EU Medical Devices Regulation (MDR 2017/745) (13% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with ICH E6(R3) - Good Clinical Practice compliance?
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