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ICH E6(R3) — Good Clinical Practice
International (ICH)
vR3 (2023)
7 domains
17 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
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)
Annex 1 - Data Governance
2 controls
| Code | Title |
|---|---|
| E6R3-A1.10 | Electronic Systems and Records |
| E6R3-A1.9 | Data Governance Framework |
Annex 1 - IRB/IEC Responsibilities
2 controls
| Code | Title |
|---|---|
| E6R3-A1.1 | IRB/IEC Composition and Functions |
| E6R3-A1.2 | Review Process |
Annex 1 - Investigator Responsibilities
3 controls
| Code | Title |
|---|---|
| E6R3-A1.3 | Investigator Qualifications and Resources |
| E6R3-A1.4 | Informed Consent |
| E6R3-A1.5 | Investigator Recordkeeping |
Annex 1 - Sponsor Responsibilities
3 controls
| 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
2 controls
| Code | Title |
|---|---|
| E6R3-A2.1 | Decentralized Trials |
| E6R3-A2.2 | Adaptive and Platform Trials |
Overarching Principles
5 controls
| 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 |
Quality Management
0 controls
AS&D quality system requirements
Maps to 481 other frameworks
17 total controls
Aged Care Quality Standards (Australia)
5 source controls mapped|4 target controls covered
29%
ICH Q10 — Pharmaceutical Quality System
5 source controls mapped|5 target controls covered
29%
EU Medical Devices Regulation (MDR 2017/745)
5 source controls mapped|8 target controls covered
29%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
5 source controls mapped|9 target controls covered
29%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
5 source controls mapped|10 target controls covered
29%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
5 source controls mapped|6 target controls covered
29%
BS 65000:2014 — Guidance on Organizational Resilience
5 source controls mapped|7 target controls covered
29%
IEC 60601-1 — Medical Electrical Equipment Safety
4 source controls mapped|4 target controls covered
24%
Colorado AI Act (SB 24-205)
4 source controls mapped|2 target controls covered
24%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
4 source controls mapped|5 target controls covered
24%
Security of Critical Infrastructure Act 2018 (SOCI)
4 source controls mapped|4 target controls covered
24%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
4 source controls mapped|8 target controls covered
24%
FDA Quality Management System Regulation (QMSR)
4 source controls mapped|7 target controls covered
24%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
4 source controls mapped|4 target controls covered
24%
Australia My Health Records Act 2012
4 source controls mapped|6 target controls covered
24%
CDP (formerly Carbon Disclosure Project)
4 source controls mapped|5 target controls covered
24%
GAMP 5 — Good Automated Manufacturing Practice
4 source controls mapped|4 target controls covered
24%
FAA Cybersecurity Framework for Aviation
4 source controls mapped|7 target controls covered
24%
Australian Energy Sector Cyber Security Framework (AESCSF)
4 source controls mapped|7 target controls covered
24%
AASB S2 Climate-related Disclosures
4 source controls mapped|6 target controls covered
24%
Modern Slavery Act 2018 (Australia)
4 source controls mapped|2 target controls covered
24%
ILO Nursing Personnel Convention C149 (1977)
4 source controls mapped|5 target controls covered
24%
EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)
4 source controls mapped|5 target controls covered
24%
ISO 8000 — Data Quality
4 source controls mapped|5 target controls covered
24%
FATF Recommendation 16 — Virtual Asset Travel Rule
4 source controls mapped|5 target controls covered
24%
Privacy by Design (PbD) — Seven Foundational Principles
4 source controls mapped|5 target controls covered
24%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
4 source controls mapped|6 target controls covered
24%
EU Clinical Trials Regulation (CTR 536/2014)
3 source controls mapped|3 target controls covered
18%
TEFCA — Trusted Exchange Framework and Common Agreement
3 source controls mapped|4 target controls covered
18%
WELL Building Standard v2 (International WELL Building Institute)
3 source controls mapped|1 target controls covered
18%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
3 source controls mapped|9 target controls covered
18%
HIPAA Security Rule
3 source controls mapped|9 target controls covered
18%
MDS2 (Medical Device)
3 source controls mapped|4 target controls covered
18%
WHO Global Strategy on Digital Health 2020-2025
3 source controls mapped|2 target controls covered
18%
HITECH Act
3 source controls mapped|3 target controls covered
18%
UNESCO Recommendation on the Ethics of AI
3 source controls mapped|3 target controls covered
18%
EU European Health Data Space (EHDS)
3 source controls mapped|4 target controls covered
18%
Australia NHMRC National Statement on Ethical Conduct in Human Research
3 source controls mapped|2 target controls covered
18%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
3 source controls mapped|1 target controls covered
18%
Wisconsin Data Privacy Act (SB 670)
3 source controls mapped|1 target controls covered
18%
Florida Digital Bill of Rights (FDBR)
3 source controls mapped|1 target controls covered
18%
Washington My Health My Data Act (MHMD)
3 source controls mapped|1 target controls covered
18%
Florida Digital Bill of Rights (SB 262)
3 source controls mapped|1 target controls covered
18%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
3 source controls mapped|1 target controls covered
18%
Connecticut Data Privacy Act (CTDPA)
3 source controls mapped|1 target controls covered
18%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|1 target controls covered
18%
NAIC Insurance Data Security Model Law (MDL-668)
3 source controls mapped|3 target controls covered
18%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
3 source controls mapped|1 target controls covered
18%
CSA CCM v4
3 source controls mapped|6 target controls covered
18%
TISAX — Trusted Information Security Assessment Exchange
3 source controls mapped|6 target controls covered
18%
South Korea ISMS-P
3 source controls mapped|3 target controls covered
18%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
3 source controls mapped|3 target controls covered
18%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
3 source controls mapped|9 target controls covered
18%
AS9100D — Aerospace Quality Management System
3 source controls mapped|9 target controls covered
18%
ISO/IEC 27003:2017
3 source controls mapped|9 target controls covered
18%
African Union Malabo Convention
3 source controls mapped|3 target controls covered
18%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
3 source controls mapped|3 target controls covered
18%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
3 source controls mapped|3 target controls covered
18%
Uzbekistan Law on Personal Data (No. ZRU-547)
3 source controls mapped|3 target controls covered
18%
Lithuania Law on Legal Protection of Personal Data (2018)
3 source controls mapped|3 target controls covered
18%
Montenegro Law on Personal Data Protection (2023)
3 source controls mapped|3 target controls covered
18%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
3 source controls mapped|3 target controls covered
18%
Malta Data Protection Act (Cap. 586, 2018)
3 source controls mapped|3 target controls covered
18%
IEC 62304:2015 Medical Device Software Lifecycle Processes
3 source controls mapped|4 target controls covered
18%
German Supply Chain Due Diligence Act (LkSG)
3 source controls mapped|4 target controls covered
18%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
2 source controls mapped|2 target controls covered
12%
OWASP Top 10:2025
2 source controls mapped|2 target controls covered
12%
CSA STAR (Security, Trust, Assurance, and Risk)
2 source controls mapped|2 target controls covered
12%
Canada Artificial Intelligence and Data Act (AIDA)
2 source controls mapped|2 target controls covered
12%
FFIEC Cybersecurity Assessment Tool (CAT)
2 source controls mapped|3 target controls covered
12%
EU GMP Annex 11 — Computerised Systems
2 source controls mapped|2 target controls covered
12%
FedRAMP Rev 5
2 source controls mapped|4 target controls covered
12%
NIST SP 800-53 Rev 5
2 source controls mapped|6 target controls covered
12%
ASIC Cyber Resilience Good Practices
2 source controls mapped|3 target controls covered
12%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|2 target controls covered
12%
O-RAN Alliance Security Specifications (O-RAN.WG11)
2 source controls mapped|2 target controls covered
12%
NIST SP 800-82 Rev 3 — Guide to OT Security
2 source controls mapped|2 target controls covered
12%
ASD Information Security Manual (ISM)
2 source controls mapped|4 target controls covered
12%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
2 source controls mapped|3 target controls covered
12%
Canada ITSG-33 — IT Security Risk Management
2 source controls mapped|3 target controls covered
12%
New Zealand Information Security Manual (NZISM)
2 source controls mapped|3 target controls covered
12%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
2 source controls mapped|3 target controls covered
12%
South Korea Cloud Security Assurance Program (CSAP)
2 source controls mapped|3 target controls covered
12%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
2 source controls mapped|3 target controls covered
12%
ISO/IEC 25012:2008 — Data Quality Model
2 source controls mapped|4 target controls covered
12%
FTC Safeguards Rule (16 CFR Part 314)
2 source controls mapped|2 target controls covered
12%
NIST Privacy Framework 1.0
2 source controls mapped|4 target controls covered
12%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
2 source controls mapped|2 target controls covered
12%
GLI-33 — Gaming Laboratories International Event Wagering Systems
2 source controls mapped|3 target controls covered
12%
EIOPA Guidelines on ICT Security and Governance (2020)
2 source controls mapped|4 target controls covered
12%
Telecommunications Sector Security Reforms (TSSR)
2 source controls mapped|3 target controls covered
12%
Defence Security Principles Framework (DSPF)
2 source controls mapped|4 target controls covered
12%
Protective Security Policy Framework (PSPF) Release 2024
2 source controls mapped|5 target controls covered
12%
SQF Code Edition 9 — Safe Quality Food
2 source controls mapped|4 target controls covered
12%
ASEAN Data Management Framework
2 source controls mapped|4 target controls covered
12%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
2 source controls mapped|3 target controls covered
12%
China AI Regulations
2 source controls mapped|6 target controls covered
12%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
2 source controls mapped|3 target controls covered
12%
EDM Council DCAM — Data Management Capability Assessment Model
2 source controls mapped|4 target controls covered
12%
Global Cross-Border Privacy Rules (Global CBPR) Forum
2 source controls mapped|2 target controls covered
12%
Brazil AI Framework
2 source controls mapped|6 target controls covered
12%
Australia AI Ethics Framework
2 source controls mapped|6 target controls covered
12%
Singapore Model AI Governance Framework (2nd Edition)
2 source controls mapped|3 target controls covered
12%
BRCGS Global Standard for Food Safety Issue 9
2 source controls mapped|8 target controls covered
12%
3GPP Security Architecture (TS 33.501 — 5G Security)
2 source controls mapped|3 target controls covered
12%
EU Digital Services Act
2 source controls mapped|3 target controls covered
12%
EU Audiovisual Media Services Directive (AVMSD, Directive 2018/1808)
2 source controls mapped|2 target controls covered
12%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
2 source controls mapped|2 target controls covered
12%
EU Digital Services Act — Minors Protection Provisions (Regulation 2022/2065)
2 source controls mapped|2 target controls covered
12%
EU Digital Services Act — Online Gaming Platform Requirements
2 source controls mapped|2 target controls covered
12%
EU Energy Performance of Buildings Directive (EPBD Recast, Directive 2024/1275)
2 source controls mapped|2 target controls covered
12%
EU European Media Freedom Act (EMFA)
2 source controls mapped|2 target controls covered
12%
EU Machinery Regulation (Regulation (EU) 2023/1230)
2 source controls mapped|2 target controls covered
12%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
2 source controls mapped|2 target controls covered
12%
EU Maritime Single Window Environment Regulation (EU 2019/1239) and EMSA Cybersecurity
2 source controls mapped|2 target controls covered
12%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
2 source controls mapped|2 target controls covered
12%
EU Pay Transparency Directive (Directive 2023/970)
2 source controls mapped|2 target controls covered
12%
EU Platform Work Directive (Directive 2024/2831)
2 source controls mapped|2 target controls covered
12%
EU Product Liability Directive (Directive (EU) 2024/2853)
2 source controls mapped|2 target controls covered
12%
EU Seveso III Directive (Directive 2012/18/EU)
2 source controls mapped|2 target controls covered
12%
EU Taxonomy Regulation (Regulation 2020/852)
2 source controls mapped|2 target controls covered
12%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
2 source controls mapped|2 target controls covered
12%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
2 source controls mapped|2 target controls covered
12%
MiFID II / MiFIR
2 source controls mapped|2 target controls covered
12%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
2 source controls mapped|2 target controls covered
12%
Chile Personal Data Protection Law (Law No. 21.719)
2 source controls mapped|2 target controls covered
12%
Costa Rica Personal Data Protection Law (Law No. 8968)
2 source controls mapped|2 target controls covered
12%
Côte d'Ivoire Law on Personal Data Protection (Law No. 2013-450)
2 source controls mapped|2 target controls covered
12%
Georgia Law on Personal Data Protection (2012)
2 source controls mapped|2 target controls covered
12%
Colombia Data Protection Law (Law 1581 of 2012 — SIC Oversight)
2 source controls mapped|2 target controls covered
12%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
2 source controls mapped|2 target controls covered
12%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
2 source controls mapped|2 target controls covered
12%
North Macedonia Law on Personal Data Protection (2020)
2 source controls mapped|2 target controls covered
12%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
2 source controls mapped|2 target controls covered
12%
Oman Personal Data Protection Law (Royal Decree 6/2022)
2 source controls mapped|2 target controls covered
12%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
2 source controls mapped|2 target controls covered
12%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
2 source controls mapped|2 target controls covered
12%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
2 source controls mapped|2 target controls covered
12%
WCO Authorised Economic Operator (AEO) Framework
2 source controls mapped|3 target controls covered
12%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
2 source controls mapped|6 target controls covered
12%
NIS2 Directive Implementing Acts
2 source controls mapped|4 target controls covered
12%
WCO SAFE Framework of Standards to Secure and Facilitate Global Trade (2021)
2 source controls mapped|3 target controls covered
12%
Customs-Trade Partnership Against Terrorism (C-TPAT)
2 source controls mapped|3 target controls covered
12%
EU Critical Raw Materials Act (Regulation (EU) 2024/1252)
2 source controls mapped|3 target controls covered
12%
EU Chips Act (Regulation (EU) 2023/1781)
2 source controls mapped|3 target controls covered
12%
UK Telecommunications (Security) Act 2021
2 source controls mapped|3 target controls covered
12%
OECD AI Principles
2 source controls mapped|6 target controls covered
12%
EU AI Act
2 source controls mapped|6 target controls covered
12%
IEEE 7000
2 source controls mapped|6 target controls covered
12%
Singapore AI Governance Framework
2 source controls mapped|6 target controls covered
12%
ISO 42001
2 source controls mapped|6 target controls covered
12%
DO-178C / ED-12C — Software Considerations in Airborne Systems
2 source controls mapped|4 target controls covered
12%
UK AI Regulation Framework
2 source controls mapped|6 target controls covered
12%
ISO/IEC 23894:2023
2 source controls mapped|5 target controls covered
12%
AICPA Privacy Management Framework (PMF)
2 source controls mapped|2 target controls covered
12%
Japan AI Guidelines
2 source controls mapped|6 target controls covered
12%
COSO ERM
2 source controls mapped|4 target controls covered
12%
ISO 28001:2007 Supply Chain Security Management
2 source controls mapped|4 target controls covered
12%
ISO 20400:2017 — Sustainable Procurement
2 source controls mapped|2 target controls covered
12%
Voluntary Principles on Security and Human Rights (VPs)
2 source controls mapped|2 target controls covered
12%
EU Better Internet for Kids (BIK+) Strategy
2 source controls mapped|2 target controls covered
12%
ISO 31000
2 source controls mapped|4 target controls covered
12%
NIST SP 800-30
2 source controls mapped|4 target controls covered
12%
ISO 27005
2 source controls mapped|4 target controls covered
12%
NIST SP 800-37
2 source controls mapped|4 target controls covered
12%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
2 source controls mapped|2 target controls covered
12%
NIST SP 800-39
2 source controls mapped|4 target controls covered
12%
EASA Part-IS — Information Security in Aviation
2 source controls mapped|4 target controls covered
12%
IEC 62443
2 source controls mapped|2 target controls covered
12%
IEEE 1686
2 source controls mapped|2 target controls covered
12%
Australia eSafety Commissioner — Online Safety Expectations for Industry
2 source controls mapped|4 target controls covered
12%
Notifiable Data Breaches Scheme (Australia)
2 source controls mapped|3 target controls covered
12%
EU Digital Markets Act
2 source controls mapped|3 target controls covered
12%
FTC Health Breach Notification Rule
2 source controls mapped|3 target controls covered
12%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
2 source controls mapped|3 target controls covered
12%
EAR — Export Administration Regulations
2 source controls mapped|4 target controls covered
12%
European Accessibility Act (Directive (EU) 2019/882)
2 source controls mapped|3 target controls covered
12%
EU Deforestation-Free Products Regulation (EUDR)
2 source controls mapped|3 target controls covered
12%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
2 source controls mapped|3 target controls covered
12%
EU NIS2 Directive — Energy Sector Cybersecurity Requirements (Directive 2022/2555)
2 source controls mapped|5 target controls covered
12%
US ITAR and EAR — Export Control and Data Security
2 source controls mapped|3 target controls covered
12%
US SEC Digital Assets and Crypto Regulatory Framework
2 source controls mapped|3 target controls covered
12%
Australia Consumer Data Right — Banking (CDR)
2 source controls mapped|3 target controls covered
12%
DO-326A
2 source controls mapped|2 target controls covered
12%
Critical Infrastructure Risk Management Program (CIRMP) Rules 2023
2 source controls mapped|2 target controls covered
12%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
2 source controls mapped|3 target controls covered
12%
EU Carbon Border Adjustment Mechanism (CBAM)
2 source controls mapped|2 target controls covered
12%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
2 source controls mapped|2 target controls covered
12%
Peru Personal Data Protection Law (Law No. 29733)
2 source controls mapped|2 target controls covered
12%
South Korea Personal Information Protection Act (PIPA)
2 source controls mapped|2 target controls covered
12%
ISO 27019
2 source controls mapped|2 target controls covered
12%
SEC Cybersecurity Disclosure Rules
2 source controls mapped|2 target controls covered
12%
C2M2
2 source controls mapped|2 target controls covered
12%
SASB Standards (ISSB Integrated)
2 source controls mapped|4 target controls covered
12%
SASB Standards
2 source controls mapped|4 target controls covered
12%
API 1164
2 source controls mapped|2 target controls covered
12%
TSA Pipeline Security
2 source controls mapped|2 target controls covered
12%
NIS2 Directive
2 source controls mapped|2 target controls covered
12%
IAIS Insurance Core Principles (ICPs)
2 source controls mapped|3 target controls covered
12%
BIMCO Cyber Security
2 source controls mapped|2 target controls covered
12%
AML/CTF Act 2006 (Australia)
2 source controls mapped|2 target controls covered
12%
NIST SP 1800-32
2 source controls mapped|2 target controls covered
12%
NERC CIP
2 source controls mapped|2 target controls covered
12%
CISA Zero Trust Maturity Model
1 source controls mapped|3 target controls covered
6%
NIST SP 800-171A — Assessing CUI Security Requirements
1 source controls mapped|3 target controls covered
6%
CMMC 2.0
1 source controls mapped|3 target controls covered
6%
MITRE D3FEND
1 source controls mapped|1 target controls covered
6%
Cyber Essentials Plus
1 source controls mapped|3 target controls covered
6%
AWS Well-Architected Security Pillar
1 source controls mapped|1 target controls covered
6%
ANSSI Cybersecurity Framework
1 source controls mapped|3 target controls covered
6%
DoD Zero Trust Reference Architecture
1 source controls mapped|3 target controls covered
6%
OWASP DevSecOps Maturity Model (DSOMM)
1 source controls mapped|1 target controls covered
6%
Azure Security Benchmark
1 source controls mapped|1 target controls covered
6%
California IoT Security Law
1 source controls mapped|1 target controls covered
6%
CAIQ (CSA)
1 source controls mapped|1 target controls covered
6%
Belgium CyberFundamentals
1 source controls mapped|3 target controls covered
6%
IACS Unified Requirements E26/E27 — Cyber Resilience of Ships and On-Board Systems
1 source controls mapped|2 target controls covered
6%
3GPP Security
1 source controls mapped|1 target controls covered
6%
BSI IT-Grundschutz
1 source controls mapped|3 target controls covered
6%
IEC 62351 — Power Systems Communication Security
1 source controls mapped|1 target controls covered
6%
OWASP ASVS
1 source controls mapped|1 target controls covered
6%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
1 source controls mapped|1 target controls covered
6%
BSIMM
1 source controls mapped|1 target controls covered
6%
C5 (Germany)
1 source controls mapped|1 target controls covered
6%
ISO/IEC 27011:2024
1 source controls mapped|1 target controls covered
6%
HL7 FHIR Security Framework
1 source controls mapped|3 target controls covered
6%
EU Cyber Resilience Act
1 source controls mapped|1 target controls covered
6%
MTCS (Singapore)
1 source controls mapped|1 target controls covered
6%
MARS-E
1 source controls mapped|1 target controls covered
6%
GHG Protocol
1 source controls mapped|1 target controls covered
6%
Sigstore — Software Artifact Signing and Verification
1 source controls mapped|1 target controls covered
6%
NIST SP 800-123
1 source controls mapped|1 target controls covered
6%
NIST SP 800-187
1 source controls mapped|1 target controls covered
6%
Spain ENS
1 source controls mapped|3 target controls covered
6%
SLSA
1 source controls mapped|1 target controls covered
6%
ISO 27018
1 source controls mapped|1 target controls covered
6%
SWIFT Customer Security Programme (CSP)
1 source controls mapped|1 target controls covered
6%
TSA Pipeline Cybersecurity Directives
1 source controls mapped|1 target controls covered
6%
NIST SP 800-218
1 source controls mapped|1 target controls covered
6%
MITRE ATT&CK
1 source controls mapped|1 target controls covered
6%
DISA Security Technical Implementation Guides (STIGs)
1 source controls mapped|3 target controls covered
6%
FISMA
1 source controls mapped|3 target controls covered
6%
ISO 27799
1 source controls mapped|1 target controls covered
6%
FDA 21 CFR Part 11
1 source controls mapped|1 target controls covered
6%
PCI DSS v4.0
1 source controls mapped|3 target controls covered
6%
ISO 27043
1 source controls mapped|1 target controls covered
6%
SSDF (NIST)
1 source controls mapped|1 target controls covered
6%
ETSI EN 303 645
1 source controls mapped|1 target controls covered
6%
NIST SP 800-53A
1 source controls mapped|3 target controls covered
6%
ISO 13485
1 source controls mapped|1 target controls covered
6%
NIST SP 800-63
1 source controls mapped|1 target controls covered
6%
OpenSSF Scorecard
1 source controls mapped|1 target controls covered
6%
SIG (Shared Assessments)
1 source controls mapped|1 target controls covered
6%
NIST SP 800-146
1 source controls mapped|1 target controls covered
6%
NIST SP 800-160
1 source controls mapped|1 target controls covered
6%
US Executive Order 14028 — Improving the Nation's Cybersecurity
1 source controls mapped|1 target controls covered
6%
NIST SP 800-207
1 source controls mapped|1 target controls covered
6%
Saudi NCA ECC
1 source controls mapped|3 target controls covered
6%
PTES
1 source controls mapped|1 target controls covered
6%
NIST SP 800-172
1 source controls mapped|3 target controls covered
6%
FATF 40 Recommendations
1 source controls mapped|1 target controls covered
6%
NIST SP 800-128
1 source controls mapped|1 target controls covered
6%
NIST SP 800-137
1 source controls mapped|1 target controls covered
6%
ISO 27017
1 source controls mapped|1 target controls covered
6%
NIST SP 800-183
1 source controls mapped|1 target controls covered
6%
ISO/SAE 21434
1 source controls mapped|1 target controls covered
6%
Ghana Cybersecurity Act
1 source controls mapped|3 target controls covered
6%
ISO 27001:2022
1 source controls mapped|1 target controls covered
6%
NIST SP 800-150
1 source controls mapped|1 target controls covered
6%
UK PSTI Act
1 source controls mapped|1 target controls covered
6%
NIST SP 800-190
1 source controls mapped|1 target controls covered
6%
NIST SP 800-66
1 source controls mapped|1 target controls covered
6%
OWASP MASVS
1 source controls mapped|1 target controls covered
6%
NIST SP 800-181
1 source controls mapped|1 target controls covered
6%
OWASP SAMM
1 source controls mapped|1 target controls covered
6%
NIST SP 800-115
1 source controls mapped|1 target controls covered
6%
NIST SP 800-161
1 source controls mapped|1 target controls covered
6%
NIST SP 800-145
1 source controls mapped|1 target controls covered
6%
ISO 27002:2022
1 source controls mapped|1 target controls covered
6%
NIST SP 800-144
1 source controls mapped|1 target controls covered
6%
NIST SP 800-171
1 source controls mapped|3 target controls covered
6%
UK Gambling Commission — Cyber Resilience Requirements
1 source controls mapped|1 target controls covered
6%
UNECE WP.29 R155
1 source controls mapped|1 target controls covered
6%
CISA Secure by Design Principles
1 source controls mapped|1 target controls covered
6%
NIST SP 800-88
1 source controls mapped|1 target controls covered
6%
NIST SP 800-61
1 source controls mapped|1 target controls covered
6%
NIST SP 800-92
1 source controls mapped|1 target controls covered
6%
UNECE WP.29 R156
1 source controls mapped|1 target controls covered
6%
ISMAP (Japan)
1 source controls mapped|1 target controls covered
6%
COPPA
1 source controls mapped|3 target controls covered
6%
EU Data Governance Act (DGA)
1 source controls mapped|2 target controls covered
6%
US OFAC Sanctions Compliance Framework
1 source controls mapped|3 target controls covered
6%
Bahrain PDPL
1 source controls mapped|3 target controls covered
6%
Colombia Habeas Data Law
1 source controls mapped|3 target controls covered
6%
Colorado Privacy Act
1 source controls mapped|3 target controls covered
6%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
1 source controls mapped|1 target controls covered
6%
Privacy Act 1988 (Australia)
1 source controls mapped|3 target controls covered
6%
Switzerland FADP
1 source controls mapped|3 target controls covered
6%
APPI
1 source controls mapped|3 target controls covered
6%
ASEAN Guide on AI Governance and Ethics
1 source controls mapped|2 target controls covered
6%
Dominican Republic DPL
1 source controls mapped|3 target controls covered
6%
C-TPAT — Customs-Trade Partnership Against Terrorism
1 source controls mapped|1 target controls covered
6%
Delaware Personal Data Privacy Act
1 source controls mapped|3 target controls covered
6%
Chile DPL
1 source controls mapped|3 target controls covered
6%
CCPA/CPRA
1 source controls mapped|3 target controls covered
6%
India DPDP Act
1 source controls mapped|3 target controls covered
6%
21 CFR Part 211 — Current Good Manufacturing Practice
1 source controls mapped|3 target controls covered
6%
EDM Council CDMC — Cloud Data Management Capabilities Framework
1 source controls mapped|1 target controls covered
6%
Connecticut DPA
1 source controls mapped|3 target controls covered
6%
Argentina PDPA
1 source controls mapped|3 target controls covered
6%
21 CFR Part 58 — Good Laboratory Practice (GLP)
1 source controls mapped|1 target controls covered
6%
ASIS SPC.1-2009 — Organizational Resilience Standard
1 source controls mapped|2 target controls covered
6%
APEC Cross-Border Privacy Rules (CBPR) System
1 source controls mapped|1 target controls covered
6%
China Personal Information Protection Law (PIPL)
1 source controls mapped|1 target controls covered
6%
EU Union Customs Code (UCC) — Data Protection and Security Provisions (Regulation 952/2013)
1 source controls mapped|1 target controls covered
6%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
1 source controls mapped|1 target controls covered
6%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
1 source controls mapped|1 target controls covered
6%
Croatia Act on Implementation of the GDPR (Official Gazette 42/2018)
1 source controls mapped|1 target controls covered
6%
Portugal Law No. 58/2019 — Data Protection Implementation Act
1 source controls mapped|1 target controls covered
6%
Uruguay Personal Data Protection Act (Law No. 18.331)
1 source controls mapped|1 target controls covered
6%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
1 source controls mapped|1 target controls covered
6%
China Data Security Law (DSL)
1 source controls mapped|1 target controls covered
6%
NIST SP 800-122
1 source controls mapped|3 target controls covered
6%
Uruguay DPL
1 source controls mapped|3 target controls covered
6%
Virginia CDPA
1 source controls mapped|3 target controls covered
6%
Liechtenstein DPA
1 source controls mapped|3 target controls covered
6%
New Jersey Data Privacy Act
1 source controls mapped|3 target controls covered
6%
Iowa Consumer Data Protection Act
1 source controls mapped|3 target controls covered
6%
Jamaica DPA
1 source controls mapped|3 target controls covered
6%
Rwanda DPL
1 source controls mapped|3 target controls covered
6%
New Zealand Privacy Act
1 source controls mapped|3 target controls covered
6%
UK Data Protection Act 2018
1 source controls mapped|3 target controls covered
6%
FERPA
1 source controls mapped|3 target controls covered
6%
Saudi Arabia PDPL
1 source controls mapped|3 target controls covered
6%
Indiana Consumer Data Protection Act
1 source controls mapped|3 target controls covered
6%
China PIPL
1 source controls mapped|3 target controls covered
6%
Mexico LFPDPPP
1 source controls mapped|3 target controls covered
6%
Philippines DPA
1 source controls mapped|3 target controls covered
6%
Montana Consumer Data Privacy Act
1 source controls mapped|3 target controls covered
6%
Kentucky Consumer Data Protection Act
1 source controls mapped|3 target controls covered
6%
Nigeria NDPR
1 source controls mapped|3 target controls covered
6%
Qatar DPL
1 source controls mapped|3 target controls covered
6%
Maryland Online Data Privacy Act
1 source controls mapped|3 target controls covered
6%
FSSC 22000 — Food Safety System Certification
1 source controls mapped|3 target controls covered
6%
Vietnam PDPD
1 source controls mapped|3 target controls covered
6%
Peru DPL
1 source controls mapped|3 target controls covered
6%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
1 source controls mapped|1 target controls covered
6%
Jordan Draft Personal Data Protection Law (2022)
1 source controls mapped|1 target controls covered
6%
Norway PDPA
1 source controls mapped|3 target controls covered
6%
Taiwan PDPA
1 source controls mapped|3 target controls covered
6%
Texas Data Privacy Act
1 source controls mapped|3 target controls covered
6%
Iceland DPA
1 source controls mapped|3 target controls covered
6%
Minnesota Consumer Data Privacy Act
1 source controls mapped|3 target controls covered
6%
Tennessee IPA
1 source controls mapped|3 target controls covered
6%
PIPEDA
1 source controls mapped|3 target controls covered
6%
LGPD
1 source controls mapped|3 target controls covered
6%
PDPA Singapore
1 source controls mapped|3 target controls covered
6%
Kenya DPA
1 source controls mapped|3 target controls covered
6%
UAE PDPL
1 source controls mapped|3 target controls covered
6%
Malaysia PDPA 2010
1 source controls mapped|3 target controls covered
6%
Oregon Consumer Privacy Act
1 source controls mapped|3 target controls covered
6%
Ecuador LOPDP
1 source controls mapped|3 target controls covered
6%
Nebraska Data Privacy Act
1 source controls mapped|3 target controls covered
6%
Utah Consumer Privacy Act
1 source controls mapped|3 target controls covered
6%
Zimbabwe Data Protection Act (2021)
1 source controls mapped|1 target controls covered
6%
ISO/IEC 27006:2024
1 source controls mapped|3 target controls covered
6%
Indonesia PDP Law
1 source controls mapped|3 target controls covered
6%
South Korea PIPA
1 source controls mapped|3 target controls covered
6%
POPIA
1 source controls mapped|3 target controls covered
6%
ISO 27701
1 source controls mapped|3 target controls covered
6%
New Hampshire Privacy Act
1 source controls mapped|3 target controls covered
6%
Turkey KVKK
1 source controls mapped|3 target controls covered
6%
Mauritius DPA
1 source controls mapped|3 target controls covered
6%
PDPA Thailand
1 source controls mapped|3 target controls covered
6%
GS1 Global Standards — Supply Chain Traceability and Data Security
1 source controls mapped|3 target controls covered
6%
RICS Professional Standards — Data and Technology in Property
1 source controls mapped|1 target controls covered
6%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
1 source controls mapped|1 target controls covered
6%
ISO/IEC 27014:2020
1 source controls mapped|1 target controls covered
6%
ICAO Annex 17 — Aviation Security (AVSEC)
1 source controls mapped|1 target controls covered
6%
ISO 55001
1 source controls mapped|1 target controls covered
6%
ISO 56002
1 source controls mapped|3 target controls covered
6%
ISO 41001:2018 — Facility Management Systems
1 source controls mapped|3 target controls covered
6%
ISO 39001:2012 — Road Traffic Safety Management
1 source controls mapped|3 target controls covered
6%
ISO 37002:2021 — Whistleblowing Management Systems
1 source controls mapped|3 target controls covered
6%
ISO 50001:2018 — Energy Management Systems
1 source controls mapped|3 target controls covered
6%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
1 source controls mapped|3 target controls covered
6%
ISO 37301
1 source controls mapped|1 target controls covered
6%
NFPA 1600 — Standard on Continuity, Emergency, and Crisis Management
1 source controls mapped|2 target controls covered
6%
ISO 9001
1 source controls mapped|3 target controls covered
6%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
1 source controls mapped|1 target controls covered
6%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
1 source controls mapped|1 target controls covered
6%
IATF 16949:2016 — Quality Management System for Automotive Production
1 source controls mapped|2 target controls covered
6%
ISO 37001
1 source controls mapped|1 target controls covered
6%
ISO 45001
1 source controls mapped|1 target controls covered
6%
IRS Publication 1075 — Tax Information Security Guidelines
1 source controls mapped|1 target controls covered
6%
UK FCA/PRA Operational Resilience Framework
1 source controls mapped|1 target controls covered
6%
ITAR — International Traffic in Arms Regulations
1 source controls mapped|1 target controls covered
6%
ISO 22000
1 source controls mapped|1 target controls covered
6%
ISO 19011
1 source controls mapped|1 target controls covered
6%
SA8000:2014 — Social Accountability Standard
1 source controls mapped|1 target controls covered
6%
ISO 30401
1 source controls mapped|1 target controls covered
6%
Nevada Gaming Control Board Cybersecurity Requirements
1 source controls mapped|1 target controls covered
6%
Lloyd's Minimum Standards — Cyber Security
1 source controls mapped|1 target controls covered
6%
UK Online Safety Act 2023
1 source controls mapped|3 target controls covered
6%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
1 source controls mapped|1 target controls covered
6%
EU Network Code on Cybersecurity for the Electricity Sector
1 source controls mapped|1 target controls covered
6%
Myanmar Cybersecurity Law (2023)
1 source controls mapped|1 target controls covered
6%
Morocco Data Protection Law (09-08)
1 source controls mapped|1 target controls covered
6%
Serbia Law on Personal Data Protection (2018)
1 source controls mapped|1 target controls covered
6%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
1 source controls mapped|1 target controls covered
6%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
1 source controls mapped|1 target controls covered
6%
EU Whistleblower Protection Directive (2019/1937)
1 source controls mapped|2 target controls covered
6%
UK Modern Slavery Act 2015
1 source controls mapped|1 target controls covered
6%
Tonga Communications Act (2015) — Privacy & Data Protection
1 source controls mapped|1 target controls covered
6%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|1 target controls covered
6%
Online Safety Act 2021 (Australia)
1 source controls mapped|1 target controls covered
6%
Barbados Data Protection Act 2019
1 source controls mapped|1 target controls covered
6%
Kids Online Safety Act (KOSA)
1 source controls mapped|1 target controls covered
6%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
1 source controls mapped|3 target controls covered
6%
TNFD Recommendations
1 source controls mapped|4 target controls covered
6%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
1 source controls mapped|5 target controls covered
6%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
1 source controls mapped|3 target controls covered
6%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
1 source controls mapped|1 target controls covered
6%
APRA CPS 234
1 source controls mapped|3 target controls covered
6%
DORA
1 source controls mapped|3 target controls covered
6%
HKMA Cyber Resilience Assessment Framework (C-RAF)
1 source controls mapped|3 target controls covered
6%
BSI C5 — Cloud Computing Compliance Criteria Catalogue
1 source controls mapped|1 target controls covered
6%
APRA CPS 220 Risk Management
1 source controls mapped|3 target controls covered
6%
BCBS 239
1 source controls mapped|3 target controls covered
6%
APRA CPS 230 Operational Risk Management
1 source controls mapped|3 target controls covered
6%
FBI CJIS Security Policy
1 source controls mapped|1 target controls covered
6%
NIST AI Risk Management Framework (AI RMF 1.0)
1 source controls mapped|2 target controls covered
6%
NIST AI 600-1 Generative AI Profile
1 source controls mapped|2 target controls covered
6%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
1 source controls mapped|2 target controls covered
6%
ISO/IEC 38500:2024 — Governance of IT
1 source controls mapped|1 target controls covered
6%
EU Taxonomy Regulation
1 source controls mapped|1 target controls covered
6%
EU ePrivacy Directive (2002/58/EC)
1 source controls mapped|1 target controls covered
6%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
1 source controls mapped|1 target controls covered
6%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
1 source controls mapped|3 target controls covered
6%
Oman National Cybersecurity Framework
1 source controls mapped|3 target controls covered
6%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
1 source controls mapped|2 target controls covered
6%
ECB TIBER-EU
1 source controls mapped|3 target controls covered
6%
PCI PIN Security
1 source controls mapped|3 target controls covered
6%
PCI P2PE
1 source controls mapped|3 target controls covered
6%
COSO Enterprise Risk Management (ERM) Framework (2017)
1 source controls mapped|3 target controls covered
6%
AICPA SOC 3
1 source controls mapped|3 target controls covered
6%
PCI SSF
1 source controls mapped|3 target controls covered
6%
SWIFT CSCF
1 source controls mapped|3 target controls covered
6%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2019/04)
1 source controls mapped|2 target controls covered
6%
MAS TRM
1 source controls mapped|3 target controls covered
6%
FFIEC IT Examination Handbook
1 source controls mapped|3 target controls covered
6%
Open Banking Security
1 source controls mapped|3 target controls covered
6%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
1 source controls mapped|1 target controls covered
6%
NIST Privacy Framework Version 1.0
1 source controls mapped|2 target controls covered
6%
OECD AI Principles (2024 Update)
1 source controls mapped|1 target controls covered
6%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|3 target controls covered
6%
Japan FSA Cybersecurity Guidelines for Financial Institutions
1 source controls mapped|3 target controls covered
6%
RBI Cybersecurity Framework for Banks
1 source controls mapped|3 target controls covered
6%
Kuwait National Cybersecurity Framework
1 source controls mapped|3 target controls covered
6%
AICPA SOC 1
1 source controls mapped|3 target controls covered
6%
Solvency II
1 source controls mapped|3 target controls covered
6%
EU PSD3 and Payment Services Regulation (Proposed)
1 source controls mapped|1 target controls covered
6%
SWIFT CSP
1 source controls mapped|3 target controls covered
6%
GLBA
1 source controls mapped|3 target controls covered
6%
SEC Climate Disclosure Rule
1 source controls mapped|3 target controls covered
6%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|3 target controls covered
6%
Own Risk and Solvency Assessment (ORSA) — NAIC Model Act
1 source controls mapped|2 target controls covered
6%
HKMA SPM
1 source controls mapped|3 target controls covered
6%
EU Markets in Crypto-Assets Regulation (MiCA)
1 source controls mapped|2 target controls covered
6%
ISO 22320:2018
1 source controls mapped|1 target controls covered
6%
ECB TIBER-EU Framework
1 source controls mapped|1 target controls covered
6%
ISO 37000:2021 — Governance of Organizations
1 source controls mapped|2 target controls covered
6%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
1 source controls mapped|3 target controls covered
6%
OSFI B-13
1 source controls mapped|3 target controls covered
6%
NIST Cybersecurity Framework 2.0
1 source controls mapped|3 target controls covered
6%
Authorised Economic Operator (AEO) Programmes — Global Standards
1 source controls mapped|1 target controls covered
6%
PSD2 SCA
1 source controls mapped|3 target controls covered
6%
SSAE 18 — Attestation Standards (SOC Reporting)
1 source controls mapped|1 target controls covered
6%
ICMM Mining Principles (2024 Update)
1 source controls mapped|1 target controls covered
6%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|1 target controls covered
6%
MTCS — Multi-Tier Cloud Security (Singapore)
1 source controls mapped|1 target controls covered
6%
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 7 domains and 17 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 17 controls organised across 7 domains. The largest domains are Overarching Principles (5 controls), Annex 1 - Investigator Responsibilities (3 controls), Annex 1 - Sponsor 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 481 other compliance frameworks. The top mapping partners are Aged Care Quality Standards (Australia) (29% coverage), ICH Q10 — Pharmaceutical Quality System (29% coverage), EU Medical Devices Regulation (MDR 2017/745) (29% 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?
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 17 controls and track your progress.
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