TheArtOfService
Back to Frameworks

ICH E6(R3) - Good Clinical Practice

Self-Assess
International (ICH)
vR3 (2023)
9 domains
9 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.

Verified

ICH E6(R3) - Good Clinical Practice is a compliance framework from International (ICH) with 9 domains and 9 controls that map to 114 other frameworks. The largest domains are ICH E6 Annex 1 - Electronic Systems (1 controls), ICH E6 Annex 2 - Decentralised Elements (1 controls), ICH E6 Data Mgmt + External Data + Regulatory (1 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard BlokdykVerified against the published standard Control text last updated

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 (9)

ICH E6 Annex 1 - Electronic Systems

1 controls
Controls in the ICH E6 Annex 1 - Electronic Systems domain of ICH E6(R3) - Good Clinical Practice — 1 controls
CodeTitle
ICH-E6-Annex1-ElectronicSystems-CSV-eSig-Audit-ALCOA-DataIntegrityICH E6(R3) Annex 1 - Computer Systems + Computer System Validation (CSV) + Electronic Signature + Audit Trail + ALCOA+ Data Integrity

ICH E6 Annex 2 - Decentralised Elements

1 controls
Controls in the ICH E6 Annex 2 - Decentralised Elements domain of ICH E6(R3) - Good Clinical Practice — 1 controls
CodeTitle
ICH-E6-Annex2-DecentralisedClinicalTrials-DCT-eConsent-Remote-WearablesICH E6(R3) Annex 2 - Decentralised Clinical Trial (DCT) Elements + eConsent + Remote Monitoring + Wearables + Real-World Evidence

ICH E6 Data Mgmt + External Data + Regulatory

1 controls
Controls in the ICH E6 Data Mgmt + External Data + Regulatory domain of ICH E6(R3) - Good Clinical Practice — 1 controls
CodeTitle
ICH-E6-DataMgmt-ExternalData-EHRs-RealWorldData-Coord-FDA-EMAICH E6 Data Management + External Data + EHR + Real-World Data + Coordination FDA + EMA + PMDA + ICH Family

ICH E6 Essential Documents

1 controls
Controls in the ICH E6 Essential Documents domain of ICH E6(R3) - Good Clinical Practice — 1 controls
CodeTitle
ICH-E6-EssentialDocs-TMF-eTMF-ArchiveRetention-ICH-Section8ICH E6 Section 8 - Essential Documents + Trial Master File (TMF) + eTMF + Archive + Retention

ICH E6 IRB/IEC + Informed Consent

1 controls
Controls in the ICH E6 IRB/IEC + Informed Consent domain of ICH E6(R3) - Good Clinical Practice — 1 controls
CodeTitle
ICH-E6-IRB-IEC-EthicsCommittee-InformedConsent-VulnerableICH E6 Section 3 - Institutional Review Board (IRB) + Independent Ethics Committee (IEC) + Informed Consent + Vulnerable Populations

ICH E6 Investigator

1 controls
Controls in the ICH E6 Investigator domain of ICH E6(R3) - Good Clinical Practice — 1 controls
CodeTitle
ICH-E6-Investigator-Qualifications-Resources-Communication-SafetyReportingICH E6 Section 4 - Investigator + Qualifications + Resources + Communication + Safety Reporting + Source Document Verification

ICH E6 Protocol + IB + CSR

1 controls
Controls in the ICH E6 Protocol + IB + CSR domain of ICH E6(R3) - Good Clinical Practice — 1 controls
CodeTitle
ICH-E6-Protocol-IB-CSR-ClinicalStudyReport-AuthoringICH E6 Section 6 + 7 - Protocol + Investigator Brochure (IB) + Clinical Study Report (CSR) + Reporting

ICH E6 Scope + Principles

1 controls
Controls in the ICH E6 Scope + Principles domain of ICH E6(R3) - Good Clinical Practice — 1 controls
CodeTitle
ICH-E6-Scope-Principles-R3-2025-Risk-Based-DecentralisedClinicalICH E6 Good Clinical Practice - Scope + 13 Principles + R3 January 2025 + Risk-Based + Decentralised + Modernisation

ICH E6 Sponsor + Quality Risk Mgmt

1 controls
Controls in the ICH E6 Sponsor + Quality Risk Mgmt domain of ICH E6(R3) - Good Clinical Practice — 1 controls
CodeTitle
ICH-E6-Sponsor-QualityRiskMgmt-Monitoring-CRO-VendorICH E6 Section 5 - Sponsor + Quality Management System + Risk-Based Monitoring + CRO + Vendor Oversight

Your Compliance Coverage

If you comply with ICH E6(R3) - Good Clinical Practice, you already cover:

Aged Care Quality Standards 2019 (repealed edition)

56%

5 controls mapped

Compare →

FDA Quality Management System Regulation (QMSR)

56%

5 controls mapped

Compare →

Florida Digital Bill of Rights (FDBR)

56%

5 controls mapped

Compare →

+ 111 more: TEFCA - Trusted Exchange Framework and Common Agreement (44%), GAMP 5 - Good Automated Manufacturing Practice (44%)

See all 114 mapped frameworks ↓

Maps to 114 other frameworks

9 total controls
Aged Care Quality Standards 2019 (repealed edition)
5 source controls mapped|4 target controls covered
56%
FDA Quality Management System Regulation (QMSR)
5 source controls mapped|6 target controls covered
56%
Florida Digital Bill of Rights (FDBR)
5 source controls mapped|2 target controls covered
56%
TEFCA - Trusted Exchange Framework and Common Agreement
4 source controls mapped|2 target controls covered
44%
GAMP 5 - Good Automated Manufacturing Practice
4 source controls mapped|2 target controls covered
44%
IEC 60601-1 - Medical Electrical Equipment Safety
4 source controls mapped|5 target controls covered
44%
COSO Internal Control - Integrated Framework (2013)
3 source controls mapped|2 target controls covered
33%
HITECH Act
3 source controls mapped|3 target controls covered
33%
SWIFT CSCF
3 source controls mapped|4 target controls covered
33%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
3 source controls mapped|3 target controls covered
33%
Australia NHMRC National Statement on Ethical Conduct in Human Research
3 source controls mapped|14 target controls covered
33%
EU Clinical Trials Regulation (CTR 536/2014)
3 source controls mapped|8 target controls covered
33%
Barbados Data Protection Act 2019
3 source controls mapped|4 target controls covered
33%
FTC GLBA Safeguards Rule (16 CFR Part 314)
3 source controls mapped|3 target controls covered
33%
German Supply Chain Due Diligence Act (LkSG)
3 source controls mapped|3 target controls covered
33%
AS9100D - Aerospace Quality Management System
3 source controls mapped|3 target controls covered
33%
BRCGS Global Standard for Food Safety Issue 9
3 source controls mapped|7 target controls covered
33%
IATF 16949:2016 - Quality Management System for Automotive Production
3 source controls mapped|3 target controls covered
33%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|4 target controls covered
33%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
3 source controls mapped|7 target controls covered
33%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
3 source controls mapped|3 target controls covered
33%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
3 source controls mapped|3 target controls covered
33%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
2 source controls mapped|2 target controls covered
22%
Privacy Act 1988 (Australia)
2 source controls mapped|3 target controls covered
22%
OWASP DevSecOps Maturity Model (DSOMM)
2 source controls mapped|3 target controls covered
22%
OWASP ASVS
2 source controls mapped|2 target controls covered
22%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
2 source controls mapped|2 target controls covered
22%
MITRE D3FEND
2 source controls mapped|2 target controls covered
22%
Law No. 172-13 on the Protection of Personal Data
2 source controls mapped|1 target controls covered
22%
India DPDP Act
2 source controls mapped|1 target controls covered
22%
API 1164
2 source controls mapped|2 target controls covered
22%
SQF Code Edition 9 - Safe Quality Food
2 source controls mapped|2 target controls covered
22%
ISO/IEC 27014:2020
2 source controls mapped|1 target controls covered
22%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
2 source controls mapped|5 target controls covered
22%
Bahrain PDPL
2 source controls mapped|4 target controls covered
22%
ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
2 source controls mapped|3 target controls covered
22%
Singapore AI Governance Framework
2 source controls mapped|3 target controls covered
22%
PCI DSS 4.0
2 source controls mapped|3 target controls covered
22%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
2 source controls mapped|3 target controls covered
22%
Family Educational Rights and Privacy Act (FERPA)
2 source controls mapped|3 target controls covered
22%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
2 source controls mapped|2 target controls covered
22%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
2 source controls mapped|3 target controls covered
22%
ISO/IEC 27011:2024
2 source controls mapped|4 target controls covered
22%
Annex 11 to EU GMP - Computerised Systems
2 source controls mapped|5 target controls covered
22%
FFIEC Cybersecurity Assessment Tool (CAT)
2 source controls mapped|3 target controls covered
22%
IEC 62351 - Power Systems Communication Security
2 source controls mapped|2 target controls covered
22%
FDA 21 CFR Part 11
2 source controls mapped|3 target controls covered
22%
FedRAMP Rev 5
2 source controls mapped|3 target controls covered
22%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|2 target controls covered
22%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|3 target controls covered
22%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
2 source controls mapped|3 target controls covered
22%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|3 target controls covered
22%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
2 source controls mapped|2 target controls covered
22%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|5 target controls covered
22%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
2 source controls mapped|2 target controls covered
22%
HL7 FHIR Security Framework
1 source controls mapped|2 target controls covered
11%
OWASP Top 10:2025
1 source controls mapped|1 target controls covered
11%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
1 source controls mapped|1 target controls covered
11%
ISO/IEC 27003:2017
1 source controls mapped|1 target controls covered
11%
ISO 27005
1 source controls mapped|1 target controls covered
11%
ISO 13485
1 source controls mapped|1 target controls covered
11%
21 CFR Part 58 - Good Laboratory Practice (GLP)
1 source controls mapped|1 target controls covered
11%
21 CFR Part 211 - Current Good Manufacturing Practice
1 source controls mapped|3 target controls covered
11%
FSSC 22000 - Food Safety System Certification
1 source controls mapped|1 target controls covered
11%
GS1 Global Standards - Supply Chain Traceability and Data Security
1 source controls mapped|3 target controls covered
11%
BSI IT-Grundschutz
1 source controls mapped|3 target controls covered
11%
NIST SP 800-171
1 source controls mapped|1 target controls covered
11%
FISMA
1 source controls mapped|1 target controls covered
11%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
11%
GHG Protocol
1 source controls mapped|1 target controls covered
11%
Law on Personal Data Protection (Official Gazette No. 42/2020)
1 source controls mapped|1 target controls covered
11%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|2 target controls covered
11%
Russia Federal Law on Personal Data (152-FZ)
1 source controls mapped|1 target controls covered
11%
US Consumer Product Safety Commission (CPSC) - Connected Product Safety
1 source controls mapped|1 target controls covered
11%
ISO/IEC 27400:2022
1 source controls mapped|2 target controls covered
11%
ASD Strategies to Mitigate Cyber Security Incidents
1 source controls mapped|1 target controls covered
11%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
1 source controls mapped|1 target controls covered
11%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
1 source controls mapped|1 target controls covered
11%
Protective Security Policy Framework (PSPF) Release 2024
1 source controls mapped|1 target controls covered
11%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
1 source controls mapped|2 target controls covered
11%
India Account Aggregator Framework (RBI)
1 source controls mapped|1 target controls covered
11%
COBIT 2019
1 source controls mapped|1 target controls covered
11%
US Foreign Corrupt Practices Act (FCPA)
1 source controls mapped|1 target controls covered
11%
Illinois Biometric Information Privacy Act (BIPA)
1 source controls mapped|1 target controls covered
11%
ISO/IEC 38500:2024 - Governance of IT
1 source controls mapped|4 target controls covered
11%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
1 source controls mapped|4 target controls covered
11%
ISO 19011
1 source controls mapped|2 target controls covered
11%
ISO 31000:2018
1 source controls mapped|1 target controls covered
11%
Science Based Targets Initiative (SBTi) - Net-Zero Standard
1 source controls mapped|2 target controls covered
11%
ISO/IEC 27004:2016
1 source controls mapped|2 target controls covered
11%
ISO/IEC 29100:2024
1 source controls mapped|1 target controls covered
11%
ISO/IEC 30111:2019
1 source controls mapped|1 target controls covered
11%
ASIS SPC.1-2009 - Organizational Resilience Standard
1 source controls mapped|1 target controls covered
11%
ISO/IEC 29147:2018
1 source controls mapped|1 target controls covered
11%
ISO/IEC 27007:2020
1 source controls mapped|1 target controls covered
11%
FedRAMP High
1 source controls mapped|1 target controls covered
11%
NIST SP 800-53 Revision 5.1 HIGH
1 source controls mapped|1 target controls covered
11%
FedRAMP Moderate
1 source controls mapped|1 target controls covered
11%
NIST SP 800-53 Rev 5 MODERATE
1 source controls mapped|1 target controls covered
11%
NIST SP 800-53 Rev 5 LOW
1 source controls mapped|1 target controls covered
11%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
11%
FATF Recommendation 16 - Virtual Asset Travel Rule
1 source controls mapped|1 target controls covered
11%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|1 target controls covered
11%
GLBA
1 source controls mapped|2 target controls covered
11%
HKMA SPM
1 source controls mapped|2 target controls covered
11%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
1 source controls mapped|3 target controls covered
11%
IATA Operational Safety Audit (IOSA) Standards Manual
1 source controls mapped|1 target controls covered
11%
APRA CPS 234
1 source controls mapped|2 target controls covered
11%
AML/CTF Act 2006 (Australia)
1 source controls mapped|1 target controls covered
11%
APRA CPS 230 Operational Risk Management
1 source controls mapped|3 target controls covered
11%
FBI CJIS Security Policy
1 source controls mapped|1 target controls covered
11%
BS 65000:2014 - Guidance on Organizational Resilience
1 source controls mapped|2 target controls covered
11%
ICAO Annex 17 - Aviation Security (AVSEC)
1 source controls mapped|2 target controls covered
11%
GLI-33 - Gaming Laboratories International Event Wagering Systems
1 source controls mapped|1 target controls covered
11%
Compare ICH E6(R3) - Good Clinical Practice with Aged Care Quality Standards 2019 (repealed edition)

What is ICH E6(R3) - Good Clinical Practice and who does it apply to?

ICH E6(R3) - Good Clinical Practice is a compliance framework from International (ICH) with 9 domains and 9 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.

What does ICH E6(R3) - Good Clinical Practice actually require?

ICH E6(R3) - Good Clinical Practice has 9 controls organised across 9 domains. The largest domains are ICH E6 Annex 1 - Electronic Systems (1 controls), ICH E6 Annex 2 - Decentralised Elements (1 controls), ICH E6 Data Mgmt + External Data + Regulatory (1 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

If I already comply with another framework, how much of ICH E6(R3) - Good Clinical Practice do I already cover?

ICH E6(R3) - Good Clinical Practice maps to 114 other compliance frameworks. The top mapping partners are Aged Care Quality Standards 2019 (repealed edition) (56% coverage), FDA Quality Management System Regulation (QMSR) (56% coverage), Florida Digital Bill of Rights (FDBR) (56% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I implement ICH E6(R3) - Good Clinical Practice?

Start your ICH E6(R3) - Good Clinical Practice 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(R3) - Good Clinical Practice 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 9 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 686 frameworks.

Get Started Free →

Free forever — no credit card required