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EU Clinical Trials Regulation (CTR 536/2014)

Self-Assess
European Union
v536/2014
4 domains
17 controls

Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Replaces the Clinical Trials Directive 2001/20/EC. Establishes a harmonised framework for authorising and supervising clinical trials across the EU through the Clinical Trials Information System (CTIS). Fully applicable since January 2023.

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 (4)

Chapter II — Application and Authorisation

5 controls

Clinical trial application, assessment, and authorisation procedures

Controls in the Chapter II — Application and Authorisation domain of EU Clinical Trials Regulation (CTR 536/2014) — 5 controls
CodeTitle
CTR-II-01Single Application via CTIS
CTR-II-02Part I Assessment (Scientific)
CTR-II-03Part II Assessment (National)
CTR-II-04Tacit Authorisation
CTR-II-05Substantial Modification Procedure

Chapter III — Subject Protection

4 controls

Informed consent, protection of vulnerable subjects, and insurance/indemnification

Controls in the Chapter III — Subject Protection domain of EU Clinical Trials Regulation (CTR 536/2014) — 4 controls
CodeTitle
CTR-III-01Informed Consent Requirements
CTR-III-02Protection of Minors
CTR-III-03Protection of Incapacitated Subjects
CTR-III-04Damage Compensation and Insurance

Chapter V-VII — Safety Reporting and GMP

4 controls

Safety reporting, manufacturing, and labelling of investigational medicinal products

Controls in the Chapter V-VII — Safety Reporting and GMP domain of EU Clinical Trials Regulation (CTR 536/2014) — 4 controls
CodeTitle
CTR-V-01Suspected Unexpected Serious Adverse Reaction (SUSAR) Reporting
CTR-V-02Annual Safety Report
CTR-VI-01GMP for Investigational Medicinal Products
CTR-VII-01Labelling of Investigational Medicinal Products

Chapter VIII-XI — Supervision and Transparency

4 controls

Inspections, transparency, data protection, and enforcement

Controls in the Chapter VIII-XI — Supervision and Transparency domain of EU Clinical Trials Regulation (CTR 536/2014) — 4 controls
CodeTitle
CTR-IX-01EU Database and Transparency
CTR-VIII-01Inspections by Member States
CTR-X-01Data Protection Compliance
CTR-XI-01Penalties for Non-Compliance

Maps to 566 other frameworks

17 total controls
Connecticut Data Privacy Act (CTDPA)
5 source controls mapped|16 target controls covered
29%
Florida Digital Bill of Rights (FDBR)
5 source controls mapped|13 target controls covered
29%
Australia My Health Records Act 2012
5 source controls mapped|8 target controls covered
29%
IEC 60601-1 — Medical Electrical Equipment Safety
4 source controls mapped|3 target controls covered
24%
Angola Personal Data Protection Law (Law No. 22/11)
4 source controls mapped|15 target controls covered
24%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
4 source controls mapped|10 target controls covered
24%
TEFCA — Trusted Exchange Framework and Common Agreement
4 source controls mapped|5 target controls covered
24%
ILO Nursing Personnel Convention C149 (1977)
4 source controls mapped|7 target controls covered
24%
EU Anti-Money Laundering Directive (AMLD6 / Directive 2018/1673)
4 source controls mapped|11 target controls covered
24%
ISO 8000 — Data Quality
4 source controls mapped|7 target controls covered
24%
FATF Recommendation 16 — Virtual Asset Travel Rule
4 source controls mapped|6 target controls covered
24%
Privacy by Design (PbD) — Seven Foundational Principles
4 source controls mapped|5 target controls covered
24%
BS 65000:2014 — Guidance on Organizational Resilience
4 source controls mapped|5 target controls covered
24%
Wisconsin Data Privacy Act (SB 670)
4 source controls mapped|11 target controls covered
24%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
4 source controls mapped|5 target controls covered
24%
MiFID II / MiFIR
4 source controls mapped|8 target controls covered
24%
Australia Consumer Data Right — Banking (CDR)
4 source controls mapped|7 target controls covered
24%
Illinois Biometric Information Privacy Act (BIPA)
4 source controls mapped|4 target controls covered
24%
NAIC Insurance Data Security Model Law (MDL-668)
4 source controls mapped|9 target controls covered
24%
Modern Slavery Act 2018 (Australia)
4 source controls mapped|4 target controls covered
24%
Australia NHMRC National Statement on Ethical Conduct in Human Research
4 source controls mapped|4 target controls covered
24%
EU European Health Data Space (EHDS)
4 source controls mapped|4 target controls covered
24%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
4 source controls mapped|4 target controls covered
24%
WHO Global Strategy on Digital Health 2020-2025
4 source controls mapped|3 target controls covered
24%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
4 source controls mapped|5 target controls covered
24%
GAMP 5 — Good Automated Manufacturing Practice
4 source controls mapped|3 target controls covered
24%
FAA Cybersecurity Framework for Aviation
4 source controls mapped|5 target controls covered
24%
AASB S2 Climate-related Disclosures
4 source controls mapped|3 target controls covered
24%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
4 source controls mapped|7 target controls covered
24%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
4 source controls mapped|4 target controls covered
24%
ICH Q10 — Pharmaceutical Quality System
4 source controls mapped|5 target controls covered
24%
Notifiable Data Breaches Scheme (Australia)
4 source controls mapped|4 target controls covered
24%
Florida Digital Bill of Rights (SB 262)
4 source controls mapped|4 target controls covered
24%
FDA Quality Management System Regulation (QMSR)
4 source controls mapped|4 target controls covered
24%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
4 source controls mapped|6 target controls covered
24%
EU Digital Markets Act
4 source controls mapped|5 target controls covered
24%
US ITAR and EAR — Export Control and Data Security
4 source controls mapped|4 target controls covered
24%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
3 source controls mapped|15 target controls covered
18%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
3 source controls mapped|8 target controls covered
18%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|10 target controls covered
18%
UK Telecommunications (Security) Act 2021
3 source controls mapped|5 target controls covered
18%
ISO/IEC 27011:2024
3 source controls mapped|7 target controls covered
18%
EU Digital Services Act — Online Gaming Platform Requirements
3 source controls mapped|9 target controls covered
18%
eIDAS 2.0 — EU Digital Identity Regulation
3 source controls mapped|13 target controls covered
18%
African Union Malabo Convention
3 source controls mapped|11 target controls covered
18%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
3 source controls mapped|11 target controls covered
18%
Chile Personal Data Protection Law (Law No. 21.719)
3 source controls mapped|10 target controls covered
18%
Costa Rica Personal Data Protection Law (Law No. 8968)
3 source controls mapped|9 target controls covered
18%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
3 source controls mapped|8 target controls covered
18%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
3 source controls mapped|7 target controls covered
18%
Uzbekistan Law on Personal Data (No. ZRU-547)
3 source controls mapped|10 target controls covered
18%
Malta Data Protection Act (Cap. 586, 2018)
3 source controls mapped|15 target controls covered
18%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
3 source controls mapped|8 target controls covered
18%
Aged Care Quality Standards (Australia)
3 source controls mapped|3 target controls covered
18%
Tennessee Information Protection Act (TIPA)
3 source controls mapped|10 target controls covered
18%
EDM Council CDMC — Cloud Data Management Capabilities Framework
3 source controls mapped|5 target controls covered
18%
North Macedonia Law on Personal Data Protection (2020)
3 source controls mapped|17 target controls covered
18%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
3 source controls mapped|16 target controls covered
18%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
3 source controls mapped|13 target controls covered
18%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
3 source controls mapped|9 target controls covered
18%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
3 source controls mapped|7 target controls covered
18%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
3 source controls mapped|11 target controls covered
18%
Washington My Health My Data Act (MHMD)
3 source controls mapped|4 target controls covered
18%
ISO/IEC 27400:2022
3 source controls mapped|8 target controls covered
18%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
3 source controls mapped|8 target controls covered
18%
EU Network Code on Cybersecurity for the Electricity Sector
3 source controls mapped|12 target controls covered
18%
Portugal Law No. 58/2019 — Data Protection Implementation Act
3 source controls mapped|15 target controls covered
18%
CAIQ (CSA)
3 source controls mapped|5 target controls covered
18%
C5 (Germany)
3 source controls mapped|5 target controls covered
18%
EU Digital Services Act — Minors Protection Provisions (Regulation 2022/2065)
3 source controls mapped|14 target controls covered
18%
AWS Well-Architected Security Pillar
3 source controls mapped|5 target controls covered
18%
Colorado AI Act (SB 24-205)
3 source controls mapped|2 target controls covered
18%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|11 target controls covered
18%
CSA STAR (Security, Trust, Assurance, and Risk)
3 source controls mapped|5 target controls covered
18%
Pakistan Personal Data Protection Bill 2023
3 source controls mapped|6 target controls covered
18%
Azure Security Benchmark
3 source controls mapped|5 target controls covered
18%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
3 source controls mapped|7 target controls covered
18%
HIPAA Security Rule
3 source controls mapped|7 target controls covered
18%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
3 source controls mapped|5 target controls covered
18%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
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%
UK GDPR (UK General Data Protection Regulation)
3 source controls mapped|7 target controls covered
18%
NIST SP 800-146
3 source controls mapped|5 target controls covered
18%
South Korea ISMS-P
3 source controls mapped|5 target controls covered
18%
EU Medical Devices Regulation (MDR 2017/745)
3 source controls mapped|3 target controls covered
18%
SOC 2
3 source controls mapped|7 target controls covered
18%
Uganda Data Protection and Privacy Act (2019)
3 source controls mapped|13 target controls covered
18%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|4 target controls covered
18%
NIS2 Directive Implementing Acts
3 source controls mapped|6 target controls covered
18%
ICH E6(R3) — Good Clinical Practice
3 source controls mapped|3 target controls covered
18%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
3 source controls mapped|13 target controls covered
18%
Tanzania Personal Data Protection Act (Draft)
3 source controls mapped|15 target controls covered
18%
Ghana Data Protection Act 2012 (Act 843)
3 source controls mapped|9 target controls covered
18%
Mauritius Data Protection Act 2017
3 source controls mapped|12 target controls covered
18%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|16 target controls covered
18%
Cayman Islands Data Protection Act 2017 (DPA)
3 source controls mapped|11 target controls covered
18%
Botswana Data Protection Act (2024)
3 source controls mapped|19 target controls covered
18%
CDP (formerly Carbon Disclosure Project)
3 source controls mapped|1 target controls covered
18%
Australian Energy Sector Cyber Security Framework (AESCSF)
3 source controls mapped|2 target controls covered
18%
NIST SP 800-144
3 source controls mapped|5 target controls covered
18%
TISAX — Trusted Information Security Assessment Exchange
3 source controls mapped|5 target controls covered
18%
SSAE 18 — Attestation Standards (SOC Reporting)
3 source controls mapped|6 target controls covered
18%
UNESCO Recommendation on the Ethics of AI
3 source controls mapped|2 target controls covered
18%
ISMAP (Japan)
3 source controls mapped|5 target controls covered
18%
MDS2 (Medical Device)
3 source controls mapped|6 target controls covered
18%
ISO 27018
3 source controls mapped|5 target controls covered
18%
Brunei Personal Data Protection Order 2024 (PDPO)
3 source controls mapped|13 target controls covered
18%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
3 source controls mapped|4 target controls covered
18%
Australia Online Safety Act 2021
3 source controls mapped|5 target controls covered
18%
Kenya Data Protection Act 2019
3 source controls mapped|9 target controls covered
18%
Jamaica Data Protection Act 2020
3 source controls mapped|8 target controls covered
18%
Fiji Data Protection Bill (2020)
3 source controls mapped|12 target controls covered
18%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
3 source controls mapped|10 target controls covered
18%
Czech Republic Act on Personal Data Processing (Act No. 110/2019 Sb.)
3 source controls mapped|12 target controls covered
18%
ISO 27017
3 source controls mapped|5 target controls covered
18%
NIST SP 800-145
3 source controls mapped|5 target controls covered
18%
Defence Security Principles Framework (DSPF)
3 source controls mapped|8 target controls covered
18%
Protective Security Policy Framework (PSPF) Release 2024
3 source controls mapped|8 target controls covered
18%
Zimbabwe Data Protection Act (2021)
3 source controls mapped|10 target controls covered
18%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|2 target controls covered
18%
MTCS (Singapore)
3 source controls mapped|5 target controls covered
18%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
3 source controls mapped|5 target controls covered
18%
FedRAMP Rev 5
3 source controls mapped|14 target controls covered
18%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
3 source controls mapped|1 target controls covered
18%
HITECH Act
3 source controls mapped|4 target controls covered
18%
NIST SP 800-190
3 source controls mapped|5 target controls covered
18%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
3 source controls mapped|5 target controls covered
18%
EU Markets in Crypto-Assets Regulation (MiCA)
3 source controls mapped|8 target controls covered
18%
EAR — Export Administration Regulations
3 source controls mapped|5 target controls covered
18%
FTC Health Breach Notification Rule
3 source controls mapped|5 target controls covered
18%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
3 source controls mapped|3 target controls covered
18%
European Accessibility Act (Directive (EU) 2019/882)
3 source controls mapped|3 target controls covered
18%
EU Deforestation-Free Products Regulation (EUDR)
3 source controls mapped|3 target controls covered
18%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
3 source controls mapped|3 target controls covered
18%
EU NIS2 Directive — Energy Sector Cybersecurity Requirements (Directive 2022/2555)
3 source controls mapped|4 target controls covered
18%
US SEC Digital Assets and Crypto Regulatory Framework
3 source controls mapped|5 target controls covered
18%
Australia eSafety Commissioner — Online Safety Expectations for Industry
3 source controls mapped|3 target controls covered
18%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|8 target controls covered
12%
China Cybersecurity Law (CSL)
2 source controls mapped|4 target controls covered
12%
China Personal Information Protection Law (PIPL)
2 source controls mapped|11 target controls covered
12%
Senegal Law on Personal Data Protection (Law No. 2008-12)
2 source controls mapped|10 target controls covered
12%
Montenegro Law on Personal Data Protection (2023)
2 source controls mapped|18 target controls covered
12%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
2 source controls mapped|14 target controls covered
12%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|5 target controls covered
12%
Philippines Cybercrime Prevention Act (RA 10175)
2 source controls mapped|4 target controls covered
12%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
2 source controls mapped|8 target controls covered
12%
Armenia Law on Protection of Personal Data (2015)
2 source controls mapped|7 target controls covered
12%
CSA CCM v4
2 source controls mapped|9 target controls covered
12%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
2 source controls mapped|12 target controls covered
12%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
2 source controls mapped|6 target controls covered
12%
EU Machinery Regulation (Regulation (EU) 2023/1230)
2 source controls mapped|12 target controls covered
12%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
2 source controls mapped|12 target controls covered
12%
EU Pay Transparency Directive (Directive 2023/970)
2 source controls mapped|11 target controls covered
12%
EU Platform Work Directive (Directive 2024/2831)
2 source controls mapped|11 target controls covered
12%
EU Product Liability Directive (Directive (EU) 2024/2853)
2 source controls mapped|11 target controls covered
12%
EU Seveso III Directive (Directive 2012/18/EU)
2 source controls mapped|9 target controls covered
12%
EU Taxonomy Regulation (Regulation 2020/852)
2 source controls mapped|7 target controls covered
12%
EU Taxonomy Regulation
2 source controls mapped|4 target controls covered
12%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
2 source controls mapped|4 target controls covered
12%
EU Union Customs Code (UCC) — Data Protection and Security Provisions (Regulation 952/2013)
2 source controls mapped|5 target controls covered
12%
EU Web Accessibility Directive (Directive 2016/2102)
2 source controls mapped|4 target controls covered
12%
EU ePrivacy Directive (2002/58/EC)
2 source controls mapped|5 target controls covered
12%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
2 source controls mapped|13 target controls covered
12%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
2 source controls mapped|8 target controls covered
12%
Morocco Data Protection Law (09-08)
2 source controls mapped|8 target controls covered
12%
Peru Personal Data Protection Law (Law No. 29733)
2 source controls mapped|10 target controls covered
12%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
2 source controls mapped|9 target controls covered
12%
Côte d'Ivoire Law on Personal Data Protection (Law No. 2013-450)
2 source controls mapped|9 target controls covered
12%
Georgia Law on Personal Data Protection (2012)
2 source controls mapped|10 target controls covered
12%
Colombia Data Protection Law (Law 1581 of 2012 — SIC Oversight)
2 source controls mapped|7 target controls covered
12%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
2 source controls mapped|16 target controls covered
12%
Serbia Law on Personal Data Protection (2018)
2 source controls mapped|11 target controls covered
12%
Lithuania Law on Legal Protection of Personal Data (2018)
2 source controls mapped|8 target controls covered
12%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
2 source controls mapped|11 target controls covered
12%
Croatia Act on Implementation of the GDPR (Official Gazette 42/2018)
2 source controls mapped|5 target controls covered
12%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
2 source controls mapped|15 target controls covered
12%
Oman Personal Data Protection Law (Royal Decree 6/2022)
2 source controls mapped|8 target controls covered
12%
South Korea Personal Information Protection Act (PIPA)
2 source controls mapped|17 target controls covered
12%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
2 source controls mapped|10 target controls covered
12%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
2 source controls mapped|5 target controls covered
12%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
2 source controls mapped|7 target controls covered
12%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
2 source controls mapped|6 target controls covered
12%
Russia Federal Law on Personal Data (152-FZ)
2 source controls mapped|8 target controls covered
12%
Barbados Data Protection Act 2019
2 source controls mapped|6 target controls covered
12%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|11 target controls covered
12%
South Korea Credit Information Act
2 source controls mapped|5 target controls covered
12%
ISO/IEC 38500:2024 — Governance of IT
2 source controls mapped|4 target controls covered
12%
EU Energy Performance of Buildings Directive (EPBD Recast, Directive 2024/1275)
2 source controls mapped|7 target controls covered
12%
Equator Principles (EP4, 2020)
2 source controls mapped|2 target controls covered
12%
Myanmar Cybersecurity Law (2023)
2 source controls mapped|5 target controls covered
12%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
2 source controls mapped|13 target controls covered
12%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
2 source controls mapped|7 target controls covered
12%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
2 source controls mapped|6 target controls covered
12%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
2 source controls mapped|5 target controls covered
12%
EU Code of Conduct for Research Data Management (GDPR Article 40)
2 source controls mapped|6 target controls covered
12%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
2 source controls mapped|7 target controls covered
12%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
2 source controls mapped|9 target controls covered
12%
ISO/IEC 29100:2024
2 source controls mapped|6 target controls covered
12%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
2 source controls mapped|8 target controls covered
12%
ISO/IEC 29134:2023
2 source controls mapped|5 target controls covered
12%
ISO/IEC 27014:2020
2 source controls mapped|4 target controls covered
12%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
2 source controls mapped|13 target controls covered
12%
Jordan Draft Personal Data Protection Law (2022)
2 source controls mapped|11 target controls covered
12%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
2 source controls mapped|2 target controls covered
12%
EU Carbon Border Adjustment Mechanism (CBAM)
2 source controls mapped|8 target controls covered
12%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
2 source controls mapped|7 target controls covered
12%
EU Audiovisual Media Services Directive (AVMSD, Directive 2018/1808)
2 source controls mapped|3 target controls covered
12%
EU European Media Freedom Act (EMFA)
2 source controls mapped|9 target controls covered
12%
Uruguay Personal Data Protection Act (Law No. 18.331)
2 source controls mapped|11 target controls covered
12%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
2 source controls mapped|5 target controls covered
12%
India Account Aggregator Framework (RBI)
2 source controls mapped|2 target controls covered
12%
C-TPAT — Customs-Trade Partnership Against Terrorism
2 source controls mapped|4 target controls covered
12%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
2 source controls mapped|3 target controls covered
12%
ASD Strategies to Mitigate Cyber Security Incidents
2 source controls mapped|3 target controls covered
12%
EU AI Liability Directive
2 source controls mapped|6 target controls covered
12%
EU Maritime Single Window Environment Regulation (EU 2019/1239) and EMSA Cybersecurity
2 source controls mapped|10 target controls covered
12%
EU NIS2 Directive — Transport Sector Requirements
2 source controls mapped|4 target controls covered
12%
RICS Professional Standards — Data and Technology in Property
2 source controls mapped|1 target controls covered
12%
GDPR
2 source controls mapped|10 target controls covered
12%
ASEAN Data Management Framework
2 source controls mapped|7 target controls covered
12%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
2 source controls mapped|3 target controls covered
12%
ISO 13485
2 source controls mapped|4 target controls covered
12%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
2 source controls mapped|3 target controls covered
12%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
2 source controls mapped|7 target controls covered
12%
NIST Privacy Framework 1.0
2 source controls mapped|7 target controls covered
12%
NIST SP 800-66
2 source controls mapped|3 target controls covered
12%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|4 target controls covered
12%
South Africa Promotion of Access to Information Act (PAIA)
2 source controls mapped|3 target controls covered
12%
Nigeria Data Protection Act 2023 (NDPA)
2 source controls mapped|8 target controls covered
12%
Virginia Consumer Data Protection Act (VCDPA)
2 source controls mapped|4 target controls covered
12%
Tonga Communications Act (2015) — Privacy & Data Protection
2 source controls mapped|3 target controls covered
12%
EU Data Governance Act (DGA)
2 source controls mapped|4 target controls covered
12%
South Korea PIPA
2 source controls mapped|6 target controls covered
12%
UK Open Banking Standard
2 source controls mapped|2 target controls covered
12%
Philippines Data Privacy Act (RA 10173)
2 source controls mapped|6 target controls covered
12%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
2 source controls mapped|4 target controls covered
12%
GLI-33 — Gaming Laboratories International Event Wagering Systems
2 source controls mapped|4 target controls covered
12%
EIOPA Guidelines on ICT Security and Governance (2020)
2 source controls mapped|3 target controls covered
12%
Telecommunications Sector Security Reforms (TSSR)
2 source controls mapped|3 target controls covered
12%
Oman National Cybersecurity Framework
2 source controls mapped|3 target controls covered
12%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
2 source controls mapped|2 target controls covered
12%
Canada ITSG-33 — IT Security Risk Management
2 source controls mapped|2 target controls covered
12%
New Zealand Information Security Manual (NZISM)
2 source controls mapped|2 target controls covered
12%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
2 source controls mapped|2 target controls covered
12%
South Korea Cloud Security Assurance Program (CSAP)
2 source controls mapped|2 target controls covered
12%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
2 source controls mapped|4 target controls covered
12%
ISO 27001:2022
2 source controls mapped|4 target controls covered
12%
AICPA Privacy Management Framework (PMF)
2 source controls mapped|5 target controls covered
12%
PropTech Security Standards — Smart Building Cybersecurity
2 source controls mapped|3 target controls covered
12%
ISO 27799
2 source controls mapped|4 target controls covered
12%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
2 source controls mapped|7 target controls covered
12%
US OFAC Sanctions Compliance Framework
2 source controls mapped|2 target controls covered
12%
DISA Security Technical Implementation Guides (STIGs)
2 source controls mapped|4 target controls covered
12%
Digital Economy Partnership Agreement (DEPA)
2 source controls mapped|3 target controls covered
12%
MARS-E
2 source controls mapped|3 target controls covered
12%
Bermuda Personal Information Protection Act 2016 (PIPA)
2 source controls mapped|5 target controls covered
12%
Cook Islands Electronic Transactions Act & Privacy Provisions (2003)
2 source controls mapped|6 target controls covered
12%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
2 source controls mapped|5 target controls covered
12%
Laos Law on Prevention and Combating Cybercrime (2015)
2 source controls mapped|6 target controls covered
12%
NIST SP 800-124 Rev 2 — Mobile Device Security
2 source controls mapped|3 target controls covered
12%
NIST AI Risk Management Framework (AI RMF 1.0)
2 source controls mapped|6 target controls covered
12%
NIST AI 600-1 Generative AI Profile
2 source controls mapped|7 target controls covered
12%
Israel Protection of Privacy Law (5741-1981)
2 source controls mapped|5 target controls covered
12%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
2 source controls mapped|3 target controls covered
12%
EU Data Act
2 source controls mapped|3 target controls covered
12%
FDA 21 CFR Part 11
2 source controls mapped|4 target controls covered
12%
OWASP Top 10 for LLM Applications 2025
2 source controls mapped|4 target controls covered
12%
ISO/IEC 23894:2023
2 source controls mapped|4 target controls covered
12%
OWASP Top 10:2025
2 source controls mapped|3 target controls covered
12%
OWASP ASVS
2 source controls mapped|2 target controls covered
12%
BSIMM
2 source controls mapped|2 target controls covered
12%
IEC 62351 — Power Systems Communication Security
2 source controls mapped|2 target controls covered
12%
HL7 FHIR Security Framework
2 source controls mapped|3 target controls covered
12%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
2 source controls mapped|4 target controls covered
12%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
2 source controls mapped|3 target controls covered
12%
ICAO Annex 17 — Aviation Security (AVSEC)
2 source controls mapped|4 target controls covered
12%
California IoT Security Law
2 source controls mapped|2 target controls covered
12%
3GPP Security
2 source controls mapped|2 target controls covered
12%
3GPP 5G Security Architecture (TS 33.501)
2 source controls mapped|4 target controls covered
12%
NIST SP 800-160
2 source controls mapped|2 target controls covered
12%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
2 source controls mapped|5 target controls covered
12%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
2 source controls mapped|5 target controls covered
12%
FBI CJIS Security Policy
2 source controls mapped|5 target controls covered
12%
NIST SP 800-88
2 source controls mapped|2 target controls covered
12%
UK PSTI Act
2 source controls mapped|2 target controls covered
12%
ISO 27043
2 source controls mapped|2 target controls covered
12%
NIST SP 800-181
2 source controls mapped|2 target controls covered
12%
ETSI EN 303 645
2 source controls mapped|2 target controls covered
12%
O-RAN Alliance Security Specifications (O-RAN.WG11)
2 source controls mapped|4 target controls covered
12%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
2 source controls mapped|4 target controls covered
12%
SIG (Shared Assessments)
2 source controls mapped|2 target controls covered
12%
ASD Information Security Manual (ISM)
2 source controls mapped|5 target controls covered
12%
OpenSSF Scorecard
2 source controls mapped|2 target controls covered
12%
NIST SP 800-63
2 source controls mapped|2 target controls covered
12%
NIST SP 800-92
2 source controls mapped|2 target controls covered
12%
NIST SP 800-115
2 source controls mapped|2 target controls covered
12%
NIST SP 800-123
2 source controls mapped|2 target controls covered
12%
ITAR — International Traffic in Arms Regulations
2 source controls mapped|4 target controls covered
12%
PTES
2 source controls mapped|2 target controls covered
12%
NIST SP 800-150
2 source controls mapped|2 target controls covered
12%
NIST Cybersecurity Framework 2.0
2 source controls mapped|2 target controls covered
12%
MITRE D3FEND
2 source controls mapped|2 target controls covered
12%
NIST SP 800-137
2 source controls mapped|2 target controls covered
12%
MITRE ATT&CK
2 source controls mapped|2 target controls covered
12%
SWIFT Customer Security Programme (CSP)
2 source controls mapped|3 target controls covered
12%
OWASP DevSecOps Maturity Model (DSOMM)
2 source controls mapped|6 target controls covered
12%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
2 source controls mapped|3 target controls covered
12%
NIST SP 800-218
2 source controls mapped|2 target controls covered
12%
NIST SP 800-187
2 source controls mapped|2 target controls covered
12%
SLSA
2 source controls mapped|2 target controls covered
12%
UK Gambling Commission — Cyber Resilience Requirements
2 source controls mapped|4 target controls covered
12%
EU Cyber Resilience Act
2 source controls mapped|2 target controls covered
12%
ISO 27002:2022
2 source controls mapped|2 target controls covered
12%
UNECE WP.29 R156
2 source controls mapped|2 target controls covered
12%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
2 source controls mapped|2 target controls covered
12%
ISO/SAE 21434
2 source controls mapped|2 target controls covered
12%
NIST SP 800-128
2 source controls mapped|2 target controls covered
12%
NIST SP 800-207
2 source controls mapped|2 target controls covered
12%
UNECE WP.29 R155
2 source controls mapped|2 target controls covered
12%
PCI DSS v4.0
2 source controls mapped|4 target controls covered
12%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
2 source controls mapped|4 target controls covered
12%
NIST SP 800-183
2 source controls mapped|2 target controls covered
12%
OWASP SAMM
2 source controls mapped|2 target controls covered
12%
NIST SP 800-161
2 source controls mapped|2 target controls covered
12%
OWASP MASVS
2 source controls mapped|2 target controls covered
12%
SSDF (NIST)
2 source controls mapped|2 target controls covered
12%
ISO/IEC 27006:2024
2 source controls mapped|4 target controls covered
12%
NIST SP 800-61
2 source controls mapped|2 target controls covered
12%
NIST SP 800-82 Rev 3 — Guide to OT Security
2 source controls mapped|3 target controls covered
12%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
2 source controls mapped|4 target controls covered
12%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
2 source controls mapped|2 target controls covered
12%
Connecticut DPA
1 source controls mapped|5 target controls covered
6%
US EPA Safe Drinking Water Act (SDWA) — Cybersecurity Requirements
1 source controls mapped|3 target controls covered
6%
UK Modern Slavery Act 2015
1 source controls mapped|3 target controls covered
6%
Canada's Anti-Spam Legislation (CASL)
1 source controls mapped|3 target controls covered
6%
Zambia Data Protection Act (2021)
1 source controls mapped|6 target controls covered
6%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|3 target controls covered
6%
Bahrain PDPL
1 source controls mapped|5 target controls covered
6%
APPI
1 source controls mapped|5 target controls covered
6%
COPPA
1 source controls mapped|5 target controls covered
6%
Colombia Habeas Data Law
1 source controls mapped|5 target controls covered
6%
Colorado Privacy Act (CPA)
1 source controls mapped|14 target controls covered
6%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|5 target controls covered
6%
Australia AI Ethics Framework
1 source controls mapped|2 target controls covered
6%
China AI Regulations
1 source controls mapped|2 target controls covered
6%
APEC Cross-Border Privacy Rules (CBPR) System
1 source controls mapped|3 target controls covered
6%
Australian Privacy Principles (APPs)
1 source controls mapped|3 target controls covered
6%
CCPA/CPRA
1 source controls mapped|5 target controls covered
6%
Chile DPL
1 source controls mapped|5 target controls covered
6%
Canada Artificial Intelligence and Data Act (AIDA)
1 source controls mapped|2 target controls covered
6%
Global Cross-Border Privacy Rules (Global CBPR) Forum
1 source controls mapped|3 target controls covered
6%
Switzerland FADP
1 source controls mapped|5 target controls covered
6%
Colorado Privacy Act
1 source controls mapped|5 target controls covered
6%
Privacy Act 1988 (Australia)
1 source controls mapped|5 target controls covered
6%
ASEAN Guide on AI Governance and Ethics
1 source controls mapped|1 target controls covered
6%
Argentina PDPA
1 source controls mapped|5 target controls covered
6%
US Consumer Product Safety Commission (CPSC) — Connected Product Safety
1 source controls mapped|1 target controls covered
6%
ESRB Privacy Certified Programme
1 source controls mapped|6 target controls covered
6%
Brazil AI Framework
1 source controls mapped|2 target controls covered
6%
Customs-Trade Partnership Against Terrorism (C-TPAT)
1 source controls mapped|1 target controls covered
6%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
1 source controls mapped|2 target controls covered
6%
EU AI Act
1 source controls mapped|2 target controls covered
6%
Nebraska Data Privacy Act
1 source controls mapped|5 target controls covered
6%
Taiwan PDPA
1 source controls mapped|5 target controls covered
6%
Dominican Republic DPL
1 source controls mapped|5 target controls covered
6%
Iceland DPA
1 source controls mapped|5 target controls covered
6%
Delaware Personal Data Privacy Act
1 source controls mapped|5 target controls covered
6%
PIPEDA
1 source controls mapped|5 target controls covered
6%
Texas Data Privacy Act
1 source controls mapped|4 target controls covered
6%
Uruguay DPL
1 source controls mapped|5 target controls covered
6%
China PIPL
1 source controls mapped|5 target controls covered
6%
Utah Consumer Privacy Act
1 source controls mapped|5 target controls covered
6%
Indonesia PDP Law
1 source controls mapped|5 target controls covered
6%
IEEE 7000
1 source controls mapped|2 target controls covered
6%
Norway PDPA
1 source controls mapped|5 target controls covered
6%
Minnesota Consumer Data Privacy Act
1 source controls mapped|5 target controls covered
6%
India DPDP Act
1 source controls mapped|5 target controls covered
6%
FERPA
1 source controls mapped|5 target controls covered
6%
Vietnam PDPD
1 source controls mapped|5 target controls covered
6%
New Hampshire Privacy Act
1 source controls mapped|5 target controls covered
6%
PDPA Singapore
1 source controls mapped|5 target controls covered
6%
Montana Consumer Data Privacy Act
1 source controls mapped|5 target controls covered
6%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
1 source controls mapped|3 target controls covered
6%
Malaysia PDPA 2010
1 source controls mapped|5 target controls covered
6%
Tennessee IPA
1 source controls mapped|5 target controls covered
6%
Iowa Consumer Data Protection Act
1 source controls mapped|5 target controls covered
6%
NIST Privacy Framework Version 1.0
1 source controls mapped|4 target controls covered
6%
Kentucky Consumer Data Protection Act
1 source controls mapped|6 target controls covered
6%
Liechtenstein DPA
1 source controls mapped|5 target controls covered
6%
POPIA
1 source controls mapped|5 target controls covered
6%
Peru DPL
1 source controls mapped|5 target controls covered
6%
Qatar DPL
1 source controls mapped|5 target controls covered
6%
Nigeria NDPR
1 source controls mapped|5 target controls covered
6%
ISO 27701
1 source controls mapped|5 target controls covered
6%
Kenya DPA
1 source controls mapped|5 target controls covered
6%
Ecuador LOPDP
1 source controls mapped|5 target controls covered
6%
Saudi Arabia PDPL
1 source controls mapped|5 target controls covered
6%
UK Age Appropriate Design Code (Children's Code)
1 source controls mapped|6 target controls covered
6%
Rwanda DPL
1 source controls mapped|5 target controls covered
6%
Turkey KVKK
1 source controls mapped|5 target controls covered
6%
Oregon Consumer Privacy Act
1 source controls mapped|5 target controls covered
6%
Indiana Consumer Data Protection Act
1 source controls mapped|3 target controls covered
6%
UK Data Protection Act 2018
1 source controls mapped|6 target controls covered
6%
Japan AI Guidelines
1 source controls mapped|2 target controls covered
6%
LGPD
1 source controls mapped|5 target controls covered
6%
UNICEF Policy Guidance on AI for Children (2021)
1 source controls mapped|2 target controls covered
6%
China Data Security Law (DSL)
1 source controls mapped|1 target controls covered
6%
Maryland Online Data Privacy Act
1 source controls mapped|3 target controls covered
6%
Virginia CDPA
1 source controls mapped|5 target controls covered
6%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
1 source controls mapped|2 target controls covered
6%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
1 source controls mapped|2 target controls covered
6%
ENISA Privacy Enhancing Technologies (PETs) Guidance
1 source controls mapped|2 target controls covered
6%
Philippines DPA
1 source controls mapped|5 target controls covered
6%
Jamaica DPA
1 source controls mapped|5 target controls covered
6%
ISO 42001
1 source controls mapped|2 target controls covered
6%
PDPA Thailand
1 source controls mapped|5 target controls covered
6%
New Jersey Data Privacy Act
1 source controls mapped|5 target controls covered
6%
New Zealand Privacy Act
1 source controls mapped|5 target controls covered
6%
Mauritius DPA
1 source controls mapped|5 target controls covered
6%
UK AI Regulation Framework
1 source controls mapped|2 target controls covered
6%
Privacy and Other Legislation Amendment Act 2024 (Australia)
1 source controls mapped|3 target controls covered
6%
Mexico LFPDPPP
1 source controls mapped|5 target controls covered
6%
NIST SP 800-122
1 source controls mapped|5 target controls covered
6%
UAE PDPL
1 source controls mapped|5 target controls covered
6%
Kids Online Safety Act (KOSA)
1 source controls mapped|2 target controls covered
6%
COSO Internal Control — Integrated Framework (2013)
1 source controls mapped|1 target controls covered
6%
Voluntary Principles on Security and Human Rights (VPs)
1 source controls mapped|1 target controls covered
6%
Hong Kong Personal Data (Privacy) Ordinance (PDPO, Cap 486)
1 source controls mapped|2 target controls covered
6%
SASB Standards (ISSB Integrated)
1 source controls mapped|2 target controls covered
6%
SASB Standards
1 source controls mapped|2 target controls covered
6%
Student Privacy Pledge 2020
1 source controls mapped|4 target controls covered
6%
Singapore AI Governance Framework
1 source controls mapped|2 target controls covered
6%
OECD AI Principles
1 source controls mapped|2 target controls covered
6%
ISO 26000:2010
1 source controls mapped|1 target controls covered
6%
ITU-T X.805 — Security Architecture for End-to-End Communications
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%
FTC Safeguards Rule (16 CFR Part 314)
1 source controls mapped|2 target controls covered
6%
CISA Zero Trust Maturity Model
1 source controls mapped|1 target controls covered
6%
NIST SP 800-171A — Assessing CUI Security Requirements
1 source controls mapped|3 target controls covered
6%
FFIEC Cybersecurity Assessment Tool (CAT)
1 source controls mapped|1 target controls covered
6%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
6%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
6%
US Automated Commercial Environment (ACE) — CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
6%
ANSSI Cybersecurity Framework
1 source controls mapped|1 target controls covered
6%
OWASP API Security Top 10:2023
1 source controls mapped|3 target controls covered
6%
Cyber Essentials Plus
1 source controls mapped|1 target controls covered
6%
CMMC 2.0
1 source controls mapped|1 target controls covered
6%
Authorised Economic Operator (AEO) Programmes — Global Standards
1 source controls mapped|1 target controls covered
6%
NIST SP 800-53 Rev 5
1 source controls mapped|3 target controls covered
6%
ILO Tripartite Declaration of Principles concerning Multinational Enterprises (MNE Declaration)
1 source controls mapped|1 target controls covered
6%
ASD Essential Eight Maturity Model
1 source controls mapped|3 target controls covered
6%
Saudi NCA ECC
1 source controls mapped|1 target controls covered
6%
CWE Top 25 Most Dangerous Software Weaknesses (2024)
1 source controls mapped|3 target controls covered
6%
NIST SP 800-172
1 source controls mapped|1 target controls covered
6%
FISMA
1 source controls mapped|1 target controls covered
6%
WCO Authorised Economic Operator (AEO) Framework
1 source controls mapped|3 target controls covered
6%
TSA Pipeline Security
1 source controls mapped|1 target controls covered
6%
NIST SP 800-171
1 source controls mapped|1 target controls covered
6%
CNCF Cloud Native Security (Cloud Native Computing Foundation)
1 source controls mapped|1 target controls covered
6%
NIST SP 800-53A
1 source controls mapped|1 target controls covered
6%
DoD Zero Trust Reference Architecture
1 source controls mapped|1 target controls covered
6%
Samoa Telecommunications Act (2005) — Privacy & Data Protection
1 source controls mapped|2 target controls covered
6%
CISA Secure by Design Principles
1 source controls mapped|1 target controls covered
6%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
1 source controls mapped|1 target controls covered
6%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
6%
TSA Pipeline Cybersecurity Directives
1 source controls mapped|1 target controls covered
6%
Spain ENS
1 source controls mapped|1 target controls covered
6%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
1 source controls mapped|3 target controls covered
6%
ISO/IEC 29147:2018
1 source controls mapped|3 target controls covered
6%
IFRS 17 — Insurance Contracts
1 source controls mapped|2 target controls covered
6%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
1 source controls mapped|3 target controls covered
6%
BRCGS Global Standard for Food Safety Issue 9
1 source controls mapped|3 target controls covered
6%
COBIT 2019
1 source controls mapped|1 target controls covered
6%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
1 source controls mapped|1 target controls covered
6%
3GPP Security Architecture (TS 33.501 — 5G Security)
1 source controls mapped|5 target controls covered
6%
US Foreign Corrupt Practices Act (FCPA)
1 source controls mapped|1 target controls covered
6%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
1 source controls mapped|3 target controls covered
6%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
6%
Science Based Targets initiative (SBTi) Corporate Standard
1 source controls mapped|2 target controls covered
6%
ISO/IEC 27007:2020
1 source controls mapped|1 target controls covered
6%
21 CFR Part 58 — Good Laboratory Practice (GLP)
1 source controls mapped|2 target controls covered
6%
ISO/IEC 27004:2016
1 source controls mapped|3 target controls covered
6%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
1 source controls mapped|1 target controls covered
6%
SQF Code Edition 9 — Safe Quality Food
1 source controls mapped|1 target controls covered
6%
ASIS SPC.1-2009 — Organizational Resilience Standard
1 source controls mapped|1 target controls covered
6%
ISO/IEC 30111:2019
1 source controls mapped|3 target controls covered
6%
APRA Prudential Standard CPS 234 — Information Security (Australia)
1 source controls mapped|1 target controls covered
6%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
1 source controls mapped|1 target controls covered
6%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
1 source controls mapped|1 target controls covered
6%
21 CFR Part 211 — Current Good Manufacturing Practice
1 source controls mapped|1 target controls covered
6%
BCBS 239
1 source controls mapped|1 target controls covered
6%
HKMA Cyber Resilience Assessment Framework (C-RAF)
1 source controls mapped|2 target controls covered
6%
TNFD Recommendations
1 source controls mapped|4 target controls covered
6%
APRA CPS 234
1 source controls mapped|1 target controls covered
6%
BREEAM — Building Research Establishment Environmental Assessment Method
1 source controls mapped|1 target controls covered
6%
IAIS Insurance Core Principles (ICPs)
1 source controls mapped|1 target controls covered
6%
ISO 56002
1 source controls mapped|4 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%
EDM Council DCAM — Data Management Capability Assessment Model
1 source controls mapped|3 target controls covered
6%
Online Safety Act 2021 (Australia)
1 source controls mapped|3 target controls covered
6%
EU GMP Annex 11 — Computerised Systems
1 source controls mapped|3 target controls covered
6%
IEC 62304:2015 Medical Device Software Lifecycle Processes
1 source controls mapped|3 target controls covered
6%
HKMA SPM
1 source controls mapped|1 target controls covered
6%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|2 target controls covered
6%
Japan FSA Cybersecurity Guidelines for Financial Institutions
1 source controls mapped|2 target controls covered
6%
RBI Cybersecurity Framework for Banks
1 source controls mapped|2 target controls covered
6%
Kuwait National Cybersecurity Framework
1 source controls mapped|2 target controls covered
6%
DO-178C / ED-12C — Software Considerations in Airborne Systems
1 source controls mapped|3 target controls covered
6%
ISO 26262:2018 — Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
6%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
1 source controls mapped|3 target controls covered
6%
ISO/IEC 25012:2008 — Data Quality Model
1 source controls mapped|2 target controls covered
6%
ISO 22320:2018
1 source controls mapped|3 target controls covered
6%
SANS Incident Handler's Handbook and PICERL Methodology
1 source controls mapped|2 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%
ESA ECSS-E-ST-40C — Space Software Engineering Standard
1 source controls mapped|3 target controls covered
6%
ITU Radio Regulations and Space Security Standards
1 source controls mapped|1 target controls covered
6%
UK Bribery Act 2010
1 source controls mapped|3 target controls covered
6%
COSO Enterprise Risk Management (ERM) Framework (2017)
1 source controls mapped|2 target controls covered
6%
SWIFT CSP
1 source controls mapped|1 target controls covered
6%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
1 source controls mapped|2 target controls covered
6%
ECSS Software Engineering Standards (ESA)
1 source controls mapped|3 target controls covered
6%
ASIC Cyber Resilience Good Practices
1 source controls mapped|2 target controls covered
6%
EN 50126/50128/50129 — Railway RAMS and Safety
1 source controls mapped|3 target controls covered
6%
WCAG 2.2
1 source controls mapped|1 target controls covered
6%
EU PSD3 and Payment Services Regulation (Proposed)
1 source controls mapped|3 target controls covered
6%
ISO 20400:2017 — Sustainable Procurement
1 source controls mapped|2 target controls covered
6%
PSD2 SCA
1 source controls mapped|1 target controls covered
6%
FFIEC IT Examination Handbook
1 source controls mapped|1 target controls covered
6%
OSFI B-13
1 source controls mapped|1 target controls covered
6%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
1 source controls mapped|1 target controls covered
6%
PCI SSF
1 source controls mapped|1 target controls covered
6%
AICPA SOC 1
1 source controls mapped|1 target controls covered
6%
Open Banking Security
1 source controls mapped|1 target controls covered
6%
ISO 37000:2021 — Governance of Organizations
1 source controls mapped|3 target controls covered
6%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
1 source controls mapped|1 target controls covered
6%
MTCS — Multi-Tier Cloud Security (Singapore)
1 source controls mapped|2 target controls covered
6%
IATA Operational Safety Audit (IOSA) Standards Manual
1 source controls mapped|1 target controls covered
6%
UK Building Safety Act 2022
1 source controls mapped|2 target controls covered
6%
W3C Verifiable Credentials (VC) Data Model 2.0
1 source controls mapped|2 target controls covered
6%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|1 target controls covered
6%
GLBA
1 source controls mapped|1 target controls covered
6%
ETSI QKD Standards — Quantum Key Distribution (ETSI ISG QKD)
1 source controls mapped|3 target controls covered
6%
SWIFT CSCF
1 source controls mapped|1 target controls covered
6%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
1 source controls mapped|3 target controls covered
6%
DORA
1 source controls mapped|1 target controls covered
6%
ISO 28001:2007 Supply Chain Security Management
1 source controls mapped|1 target controls covered
6%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
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%
PCI P2PE
1 source controls mapped|1 target controls covered
6%
Singapore Cybersecurity Act 2018
1 source controls mapped|1 target controls covered
6%
Cyber Security Act 2024 (Australia)
1 source controls mapped|1 target controls covered
6%
ECB TIBER-EU Framework
1 source controls mapped|1 target controls covered
6%
ECB TIBER-EU
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%
MAS TRM
1 source controls mapped|1 target controls covered
6%
PCI PIN Security
1 source controls mapped|1 target controls covered
6%
AS9100D — Aerospace Quality Management System
1 source controls mapped|1 target controls covered
6%
ISO/IEC 27003:2017
1 source controls mapped|1 target controls covered
6%
AICPA SOC 3
1 source controls mapped|1 target controls covered
6%
CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)
1 source controls mapped|1 target controls covered
6%
EASA Part-IS — Information Security in Aviation
1 source controls mapped|1 target controls covered
6%
Compare EU Clinical Trials Regulation (CTR 536/2014) with Connecticut Data Privacy Act (CTDPA)

Frequently Asked Questions

What is EU Clinical Trials Regulation (CTR 536/2014)?

EU Clinical Trials Regulation (CTR 536/2014) is a compliance framework from European Union with 4 domains and 17 controls. Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. Replaces the Clinical Trials Directive 2001/20/EC. Establishes a harmonised framework for authorising and supervising clinical trials across the EU through the Clinical Trials Information System (CTIS). Fully applicable since January 2023. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

How many controls does EU Clinical Trials Regulation (CTR 536/2014) have?

EU Clinical Trials Regulation (CTR 536/2014) has 17 controls organised across 4 domains. The largest domains are Chapter II — Application and Authorisation (5 controls), Chapter III — Subject Protection (4 controls), Chapter V-VII — Safety Reporting and GMP (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does EU Clinical Trials Regulation (CTR 536/2014) map to?

EU Clinical Trials Regulation (CTR 536/2014) maps to 566 other compliance frameworks. The top mapping partners are Connecticut Data Privacy Act (CTDPA) (29% coverage), Florida Digital Bill of Rights (FDBR) (29% coverage), Australia My Health Records Act 2012 (29% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with EU Clinical Trials Regulation (CTR 536/2014) compliance?

Start your EU Clinical Trials Regulation (CTR 536/2014) compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about EU Clinical Trials Regulation (CTR 536/2014) 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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