ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
ICH E6(R2) (International Council for Harmonisation, 2016, with R3 under development) establishes international ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials. The guideline includes specific provisions for electronic systems, data integrity, and computerised systems used in clinical trials. ICH E6 is implemented in law by regulatory authorities worldwide (FDA, EMA, PMDA, NMPA). Key areas include investigator responsibilities, sponsor obligations, essential documents, quality management systems, and data quality.
Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.
Framework Domains (7)
Section 1 - Glossary
| Code | Title |
|---|---|
| E6R2-1.1 | Glossary and Definitions |
Section 2 - Principles of ICH GCP
| Code | Title |
|---|---|
| E6R2-2.1 | Ethical Conduct |
| E6R2-2.13 | Quality Management Systems |
| E6R2-2.6 | Scientific Soundness |
Section 3 - Institutional Review Board / Independent Ethics Committee (IRB/IEC)
| Code | Title |
|---|---|
| E6R2-3.1 | IRB/IEC Responsibilities |
| E6R2-3.2 | IRB/IEC Composition and Procedures |
| E6R2-3.3 | IRB/IEC Review and Approval |
Section 4 - Investigator
| Code | Title |
|---|---|
| E6R2-4.1 | Investigator Qualifications |
| E6R2-4.3 | Medical Care of Trial Subjects |
| E6R2-4.5 | Compliance with Protocol |
| E6R2-4.8 | Informed Consent of Trial Subjects |
| E6R2-4.9 | Records and Reports |
Section 5 - Sponsor
| Code | Title |
|---|---|
| E6R2-5.0 | Quality Management |
| E6R2-5.18 | Monitoring |
| E6R2-5.2 | Contract Research Organization (CRO) |
| E6R2-5.20 | Audit |
| E6R2-5.5 | Trial Management, Data Handling, and Recordkeeping |
Section 6 - Clinical Trial Protocol and Amendments
| Code | Title |
|---|---|
| E6R2-6.1 | Protocol Content |
| E6R2-6.2 | Protocol Amendments |
Section 8 - Essential Documents
| Code | Title |
|---|---|
| E6R2-8.1 | Before Clinical Phase Commences |
| E6R2-8.2 | During Clinical Conduct |
| E6R2-8.3 | After Completion or Termination |
Maps to 542 other frameworks
Frequently Asked Questions
What is ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems?
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems is a compliance framework from International (ICH) with 7 domains and 22 controls. ICH E6(R2) (International Council for Harmonisation, 2016, with R3 under development) establishes international ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials. The guideline includes specific provisions for electronic systems, data integrity, and computerised systems used in clinical trials. ICH E6 is implemented in law by regulatory authorities worldwide (FDA, EMA, PMDA, NMPA). Key areas include investigator responsibilities, sponsor obligations, essential documents, quality management systems, and data quality. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
How many controls does ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems have?
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems has 22 controls organised across 7 domains. The largest domains are Section 4 - Investigator (5 controls), Section 5 - Sponsor (5 controls), Section 2 - Principles of ICH GCP (3 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
What frameworks does ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems map to?
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems maps to 542 other compliance frameworks. The top mapping partners are ILO Nursing Personnel Convention C149 (1977) (32% coverage), EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673) (32% coverage), ISO 8000 — Data Quality (32% coverage). Use our comparison tool to explore control-level mappings between frameworks.
How do I get started with ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems compliance?
Start your ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 22 controls and track your progress.
Start Your Compliance Journey
Create a free account to run self-assessments, get AI advisory, and track your compliance progress across 692 frameworks.
Get Started Free →Free forever — no credit card required