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EU Clinical Trials Regulation (CTR 536/2014)

Self-Assess
European Union
v536/2014
16 domains
37 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 European Union through the Clinical Trials Information System (CTIS). The regulation aims to simplify and streamline the assessment and supervision of clinical trials, ensuring a high level of public health protection and transparency. It became fully applicable on 31 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 (16)

Application Process

4 controls
Controls in the Application Process domain of EU Clinical Trials Regulation (CTR 536/2014) — 4 controls
CodeTitle
CTR-APP-01Reporting Member State Selection
CTR-APP-02Validation Phase Response
CTR-APP-03Part I Scientific Assessment
CTR-APP-04Part II National Assessment

CTIS Portal

2 controls
Controls in the CTIS Portal domain of EU Clinical Trials Regulation (CTR 536/2014) — 2 controls
CodeTitle
CTR-CTIS-01CTIS Account and Sponsor Registration
CTR-CTIS-02Single Application Submission

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

Compliance

1 controls
Controls in the Compliance domain of EU Clinical Trials Regulation (CTR 536/2014) — 1 controls
CodeTitle
CTR-INS-01Inspection Readiness

Data Protection

1 controls
Controls in the Data Protection domain of EU Clinical Trials Regulation (CTR 536/2014) — 1 controls
CodeTitle
CTR-DAT-01Data Protection Compliance

Good Clinical Practice

2 controls
Controls in the Good Clinical Practice domain of EU Clinical Trials Regulation (CTR 536/2014) — 2 controls
CodeTitle
CTR-GCP-01ICH GCP E6(R3) Alignment
CTR-GCP-02Trial Master File

IMP Management

1 controls
Controls in the IMP Management domain of EU Clinical Trials Regulation (CTR 536/2014) — 1 controls
CodeTitle
CTR-INV-01Investigational Medicinal Product Management

Records Retention

1 controls
Controls in the Records Retention domain of EU Clinical Trials Regulation (CTR 536/2014) — 1 controls
CodeTitle
CTR-ARC-01Records Archival

Safety Reporting

2 controls
Controls in the Safety Reporting domain of EU Clinical Trials Regulation (CTR 536/2014) — 2 controls
CodeTitle
CTR-SAF-01Annual Safety Report
CTR-SAF-02SUSAR Reporting via EudraVigilance

Subject Protection

2 controls
Controls in the Subject Protection domain of EU Clinical Trials Regulation (CTR 536/2014) — 2 controls
CodeTitle
CTR-CON-01Informed Consent Process
CTR-CON-02Emergency and Minors Consent

Transparency

2 controls
Controls in the Transparency domain of EU Clinical Trials Regulation (CTR 536/2014) — 2 controls
CodeTitle
CTR-TRA-01Transparency Publication
CTR-TRA-02Lay Summary of Results

Trial Closure

1 controls
Controls in the Trial Closure domain of EU Clinical Trials Regulation (CTR 536/2014) — 1 controls
CodeTitle
CTR-END-01End of Trial Declaration

Trial Conduct

1 controls
Controls in the Trial Conduct domain of EU Clinical Trials Regulation (CTR 536/2014) — 1 controls
CodeTitle
CTR-SUB-01Substantial Modification Submission

Your Compliance Coverage

If you comply with EU Clinical Trials Regulation (CTR 536/2014), you already cover:

Connecticut Data Privacy Act (CTDPA)

14%

5 controls mapped

Compare →

Florida Digital Bill of Rights (FDBR)

14%

5 controls mapped

Compare →

Australia My Health Records Act 2012

14%

5 controls mapped

Compare →

+ 589 more: IEC 60601-1 — Medical Electrical Equipment Safety (11%), Angola Personal Data Protection Law (Law No. 22/11) (11%)

See all 592 mapped frameworks ↓

Maps to 592 other frameworks

37 total controls
Connecticut Data Privacy Act (CTDPA)
5 source controls mapped|16 target controls covered
14%
Florida Digital Bill of Rights (FDBR)
5 source controls mapped|13 target controls covered
14%
Australia My Health Records Act 2012
5 source controls mapped|8 target controls covered
14%
IEC 60601-1 — Medical Electrical Equipment Safety
4 source controls mapped|3 target controls covered
11%
Angola Personal Data Protection Law (Law No. 22/11)
4 source controls mapped|15 target controls covered
11%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
4 source controls mapped|10 target controls covered
11%
TEFCA — Trusted Exchange Framework and Common Agreement
4 source controls mapped|5 target controls covered
11%
ILO Nursing Personnel Convention C149 (1977)
4 source controls mapped|7 target controls covered
11%
6th Anti-Money Laundering Directive (AMLD6, Directive (EU) 2018/1673)
4 source controls mapped|11 target controls covered
11%
ISO 8000 — Data Quality
4 source controls mapped|7 target controls covered
11%
FATF Recommendation 16 — Virtual Asset Travel Rule
4 source controls mapped|6 target controls covered
11%
Privacy by Design (PbD) — Seven Foundational Principles
4 source controls mapped|5 target controls covered
11%
BS 65000:2014 — Guidance on Organizational Resilience
4 source controls mapped|5 target controls covered
11%
Wisconsin Data Privacy Act (SB 670)
4 source controls mapped|11 target controls covered
11%
DFARS 252.204-7012 — Safeguarding Covered Defense Information
4 source controls mapped|5 target controls covered
11%
MiFID II / MiFIR
4 source controls mapped|8 target controls covered
11%
Australia Consumer Data Right — Banking (CDR)
4 source controls mapped|7 target controls covered
11%
Illinois Biometric Information Privacy Act (BIPA)
4 source controls mapped|4 target controls covered
11%
NAIC Insurance Data Security Model Law (MDL-668)
4 source controls mapped|9 target controls covered
11%
Modern Slavery Act 2018 (Australia)
4 source controls mapped|4 target controls covered
11%
Australia NHMRC National Statement on Ethical Conduct in Human Research
4 source controls mapped|4 target controls covered
11%
Proposal for a Regulation on the European Health Data Space (EHDS)
4 source controls mapped|4 target controls covered
11%
ISPE GAMP 5 — A Risk-Based Approach to Compliant GxP Computerised Systems
4 source controls mapped|4 target controls covered
11%
WHO Global Strategy on Digital Health 2020-2025
4 source controls mapped|3 target controls covered
11%
ICH E6(R2) Good Clinical Practice — Data Integrity and Electronic Systems
4 source controls mapped|5 target controls covered
11%
GAMP 5 — Good Automated Manufacturing Practice
4 source controls mapped|3 target controls covered
11%
FAA Cybersecurity Framework for Aviation
4 source controls mapped|5 target controls covered
11%
AASB S2 Climate-related Disclosures
4 source controls mapped|3 target controls covered
11%
ISO 15189:2022 — Medical Laboratories Requirements for Quality and Competence
4 source controls mapped|10 target controls covered
11%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
4 source controls mapped|4 target controls covered
11%
ICH Q10 — Pharmaceutical Quality System
4 source controls mapped|5 target controls covered
11%
Notifiable Data Breaches Scheme (Australia)
4 source controls mapped|4 target controls covered
11%
Florida Digital Bill of Rights (SB 262)
4 source controls mapped|4 target controls covered
11%
FDA Quality Management System Regulation (QMSR)
4 source controls mapped|4 target controls covered
11%
ISO/IEC 17025:2017 — General Requirements for Testing and Calibration Laboratories
4 source controls mapped|6 target controls covered
11%
EU Digital Markets Act
4 source controls mapped|5 target controls covered
11%
US ITAR and EAR — Export Control and Data Security
4 source controls mapped|4 target controls covered
11%
EU AI Act
3 source controls mapped|12 target controls covered
8%
Ethiopia Personal Data Protection Proclamation (No. 1321/2024)
3 source controls mapped|15 target controls covered
8%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
3 source controls mapped|8 target controls covered
8%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|10 target controls covered
8%
UK Telecommunications (Security) Act 2021
3 source controls mapped|5 target controls covered
8%
ISO/IEC 27011:2024
3 source controls mapped|7 target controls covered
8%
COSO Internal Control — Integrated Framework (2013)
3 source controls mapped|3 target controls covered
8%
EU Cyber Solidarity Act (Regulation (EU) 2025/38)
3 source controls mapped|7 target controls covered
8%
EU Digital Services Act (Regulation (EU) 2022/2065)
3 source controls mapped|9 target controls covered
8%
eIDAS 2.0 — EU Digital Identity Regulation
3 source controls mapped|13 target controls covered
8%
African Union Malabo Convention
3 source controls mapped|11 target controls covered
8%
Egypt Personal Data Protection Law (Law No. 151 of 2020)
3 source controls mapped|11 target controls covered
8%
Chile Personal Data Protection Law (Law No. 21.719)
3 source controls mapped|10 target controls covered
8%
Costa Rica Personal Data Protection Law (Law No. 8968) as amended by Executive Decree No. 42089-MGP
3 source controls mapped|9 target controls covered
8%
Turkey Personal Data Protection Law (KVKK — Law No. 6698)
3 source controls mapped|12 target controls covered
8%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
3 source controls mapped|7 target controls covered
8%
Uzbekistan Law on Personal Data (No. ZRU-547)
3 source controls mapped|10 target controls covered
8%
Malta Data Protection Act (Cap. 586, 2018)
3 source controls mapped|15 target controls covered
8%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
3 source controls mapped|8 target controls covered
8%
Aged Care Quality Standards (Australia)
3 source controls mapped|3 target controls covered
8%
Tennessee Information Protection Act (TIPA)
3 source controls mapped|10 target controls covered
8%
EDM Council CDMC — Cloud Data Management Capability Framework
3 source controls mapped|5 target controls covered
8%
North Macedonia Law on Personal Data Protection (2020)
3 source controls mapped|17 target controls covered
8%
Latvia Personal Data Processing Law (Fizisko personu datu apstrades likums, 2018)
3 source controls mapped|16 target controls covered
8%
Finland Data Protection Act (Tietosuojalaki, 1050/2018)
3 source controls mapped|13 target controls covered
8%
Estonia Personal Data Protection Act (Isikuandmete kaitse seadus, 2019)
3 source controls mapped|9 target controls covered
8%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
3 source controls mapped|7 target controls covered
8%
Bosnia and Herzegovina Law on Protection of Personal Data (2006, amended 2011)
3 source controls mapped|11 target controls covered
8%
Washington My Health My Data Act (MHMD)
3 source controls mapped|4 target controls covered
8%
GDPR
3 source controls mapped|18 target controls covered
8%
ISO/IEC 27400:2022
3 source controls mapped|8 target controls covered
8%
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)
3 source controls mapped|8 target controls covered
8%
EU Network Code on Cybersecurity for the Electricity Sector
3 source controls mapped|12 target controls covered
8%
Portugal Law No. 58/2019 — Data Protection Implementation Act
3 source controls mapped|15 target controls covered
8%
CAIQ (CSA)
3 source controls mapped|5 target controls covered
8%
C5 (Germany)
3 source controls mapped|5 target controls covered
8%
Digital Services Act (DSA) - Regulation (EU) 2022/2065
3 source controls mapped|14 target controls covered
8%
AWS Well-Architected Security Pillar
3 source controls mapped|5 target controls covered
8%
Colorado Artificial Intelligence Act (proposed SB 24-205)
3 source controls mapped|2 target controls covered
8%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
3 source controls mapped|11 target controls covered
8%
CSA STAR (Security, Trust, Assurance, and Risk)
3 source controls mapped|5 target controls covered
8%
Pakistan Personal Data Protection Bill 2023
3 source controls mapped|6 target controls covered
8%
Azure Security Benchmark
3 source controls mapped|6 target controls covered
8%
US Gramm-Leach-Bliley Act (GLBA) — Higher Education Safeguards Rule
3 source controls mapped|7 target controls covered
8%
HIPAA Security Rule
3 source controls mapped|7 target controls covered
8%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
3 source controls mapped|5 target controls covered
8%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
3 source controls mapped|4 target controls covered
8%
WELL Building Standard v2 (International WELL Building Institute)
3 source controls mapped|1 target controls covered
8%
UK GDPR (UK General Data Protection Regulation)
3 source controls mapped|7 target controls covered
8%
ISO 13485
3 source controls mapped|5 target controls covered
8%
NIST SP 800-146
3 source controls mapped|5 target controls covered
8%
South Korea ISMS-P
3 source controls mapped|5 target controls covered
8%
EU Medical Devices Regulation (MDR 2017/745)
3 source controls mapped|3 target controls covered
8%
SOC 2
3 source controls mapped|7 target controls covered
8%
Uganda Data Protection and Privacy Act (2019)
3 source controls mapped|13 target controls covered
8%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|4 target controls covered
8%
NIS2 Directive Implementing Acts
3 source controls mapped|6 target controls covered
8%
ICH E6(R3) — Good Clinical Practice
3 source controls mapped|3 target controls covered
8%
Singapore Payment Services Act (PSA) — Digital Payment Token Regulation
3 source controls mapped|13 target controls covered
8%
Tanzania Personal Data Protection Act (Draft)
3 source controls mapped|15 target controls covered
8%
Ghana Data Protection Act 2012 (Act 843)
3 source controls mapped|9 target controls covered
8%
Mauritius Data Protection Act 2017
3 source controls mapped|12 target controls covered
8%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|16 target controls covered
8%
Cayman Islands Data Protection Act 2017 (DPA)
3 source controls mapped|11 target controls covered
8%
Botswana Data Protection Act (2024)
3 source controls mapped|19 target controls covered
8%
CDP (formerly Carbon Disclosure Project)
3 source controls mapped|1 target controls covered
8%
Australian Energy Sector Cyber Security Framework (AESCSF)
3 source controls mapped|2 target controls covered
8%
NIST SP 800-144
3 source controls mapped|5 target controls covered
8%
TISAX — Trusted Information Security Assessment Exchange
3 source controls mapped|5 target controls covered
8%
SSAE 18 — Attestation Standards (SOC Reporting)
3 source controls mapped|6 target controls covered
8%
UNESCO Recommendation on the Ethics of AI
3 source controls mapped|2 target controls covered
8%
ISMAP (Japan)
3 source controls mapped|5 target controls covered
8%
MDS2 (Medical Device)
3 source controls mapped|6 target controls covered
8%
ISO 27018
3 source controls mapped|5 target controls covered
8%
Brunei Personal Data Protection Order 2024 (PDPO)
3 source controls mapped|13 target controls covered
8%
Singapore Protection from Online Falsehoods and Manipulation Act (POFMA, 2019)
3 source controls mapped|4 target controls covered
8%
Australia Online Safety Act 2021
3 source controls mapped|5 target controls covered
8%
Kenya Data Protection Act 2019
3 source controls mapped|9 target controls covered
8%
Jamaica Data Protection Act 2020
3 source controls mapped|8 target controls covered
8%
Fiji Data Protection Bill (2020)
3 source controls mapped|12 target controls covered
8%
Denmark Data Protection Act (Databeskyttelsesloven, 2018)
3 source controls mapped|10 target controls covered
8%
Czech Republic Act on the Protection of Personal Data (Act No. 110/2019 Coll.)
3 source controls mapped|12 target controls covered
8%
ISO 27017
3 source controls mapped|5 target controls covered
8%
NIST SP 800-145
3 source controls mapped|5 target controls covered
8%
Defence Security Principles Framework (DSPF)
3 source controls mapped|8 target controls covered
8%
Protective Security Policy Framework (PSPF) Release 2024
3 source controls mapped|8 target controls covered
8%
Zimbabwe Data Protection Act (2021)
3 source controls mapped|10 target controls covered
8%
Security of Critical Infrastructure Act 2018 (SOCI)
3 source controls mapped|2 target controls covered
8%
MTCS (Singapore)
3 source controls mapped|5 target controls covered
8%
NYDFS Cybersecurity Regulation (23 NYCRR Part 500)
3 source controls mapped|5 target controls covered
8%
FedRAMP Rev 5
3 source controls mapped|14 target controls covered
8%
NATO AQAP 2110 — Quality Assurance Requirements for Design, Development, and Production
3 source controls mapped|1 target controls covered
8%
HITECH Act
3 source controls mapped|4 target controls covered
8%
NIST SP 800-190
3 source controls mapped|5 target controls covered
8%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
3 source controls mapped|5 target controls covered
8%
EU Markets in Crypto-Assets Regulation (MiCA)
3 source controls mapped|8 target controls covered
8%
EAR — Export Administration Regulations
3 source controls mapped|5 target controls covered
8%
FTC Health Breach Notification Rule
3 source controls mapped|5 target controls covered
8%
UK Product Security and Telecommunications Infrastructure Act (PSTI)
3 source controls mapped|3 target controls covered
8%
European Accessibility Act (Directive (EU) 2019/882)
3 source controls mapped|3 target controls covered
8%
Regulation (EU) 2023/1115 on deforestation-free supply chains
3 source controls mapped|3 target controls covered
8%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) — IASR Web Standard
3 source controls mapped|3 target controls covered
8%
NIS2 Directive (Directive (EU) 2022/2555)
3 source controls mapped|4 target controls covered
8%
US SEC Digital Assets and Crypto Regulatory Framework
3 source controls mapped|5 target controls covered
8%
Australia eSafety Commissioner — Online Safety Expectations for Industry
3 source controls mapped|3 target controls covered
8%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
2 source controls mapped|8 target controls covered
5%
China Cybersecurity Law (CSL)
2 source controls mapped|4 target controls covered
5%
China Personal Information Protection Law (PIPL)
2 source controls mapped|11 target controls covered
5%
Senegal Law on Personal Data Protection (Law No. 2008-12)
2 source controls mapped|10 target controls covered
5%
Montenegro Law on Personal Data Protection (2023)
2 source controls mapped|18 target controls covered
5%
Luxembourg Law of 1 August 2018 on Data Protection (GDPR Implementation)
2 source controls mapped|14 target controls covered
5%
Azerbaijan Law on Personal Data (2010)
2 source controls mapped|5 target controls covered
5%
Philippines Cybercrime Prevention Act (RA 10175)
2 source controls mapped|4 target controls covered
5%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
2 source controls mapped|8 target controls covered
5%
Armenia Law on Protection of Personal Data (2015)
2 source controls mapped|7 target controls covered
5%
CSA CCM v4
2 source controls mapped|9 target controls covered
5%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
2 source controls mapped|12 target controls covered
5%
Law 1581 of 2012 - Statutory Framework for the Protection of Personal Data
2 source controls mapped|9 target controls covered
5%
EU Machinery Regulation (Regulation (EU) 2023/1230)
2 source controls mapped|12 target controls covered
5%
EU General Product Safety Regulation (GPSR, Regulation 2023/988)
2 source controls mapped|12 target controls covered
5%
EU Pay Transparency Directive (Directive (EU) 2023/970)
2 source controls mapped|11 target controls covered
5%
Proposal for a Directive on improving working conditions in platform work (COM(2023) 491)
2 source controls mapped|11 target controls covered
5%
EU Product Liability Directive (Directive (EU) 2023/2845)
2 source controls mapped|11 target controls covered
5%
EU Seveso III Directive (Directive 2012/18/EU)
2 source controls mapped|9 target controls covered
5%
EU Taxonomy Regulation (Regulation 2020/852)
2 source controls mapped|7 target controls covered
5%
EU Taxonomy Regulation
2 source controls mapped|4 target controls covered
5%
EU Taxonomy for Sustainable Activities (Regulation 2020/852)
2 source controls mapped|4 target controls covered
5%
Union Customs Code (UCC) - Regulation (EU) No 952/2013
2 source controls mapped|5 target controls covered
5%
EU Web Accessibility Directive (Directive 2016/2102)
2 source controls mapped|4 target controls covered
5%
EU ePrivacy Directive (2002/58/EC)
2 source controls mapped|5 target controls covered
5%
Japan Act on Specified Commercial Transactions (ASCT) — Digital Services
2 source controls mapped|13 target controls covered
5%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
2 source controls mapped|8 target controls covered
5%
Morocco Data Protection Law (09-08)
2 source controls mapped|8 target controls covered
5%
Peru Personal Data Protection Law (Law No. 29733)
2 source controls mapped|10 target controls covered
5%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
2 source controls mapped|9 target controls covered
5%
Côte d'Ivoire Law No. 2013-450 on the Protection of Personal Data
2 source controls mapped|9 target controls covered
5%
Georgia Law on Personal Data Protection (2012)
2 source controls mapped|10 target controls covered
5%
Colombia Data Protection Law (Law 1581 of 2012)
2 source controls mapped|7 target controls covered
5%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
2 source controls mapped|16 target controls covered
5%
Serbia Law on Personal Data Protection (2018)
2 source controls mapped|11 target controls covered
5%
Lithuania Law on Legal Protection of Personal Data (2018)
2 source controls mapped|8 target controls covered
5%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
2 source controls mapped|11 target controls covered
5%
Act on the Implementation of the General Data Protection Regulation (OG 42/2018)
2 source controls mapped|5 target controls covered
5%
Netherlands GDPR Implementation Act (UAVG — Uitvoeringswet AVG, 2018)
2 source controls mapped|15 target controls covered
5%
Oman Personal Data Protection Law (Royal Decree 6/2022)
2 source controls mapped|8 target controls covered
5%
South Korea Personal Information Protection Act (PIPA)
2 source controls mapped|17 target controls covered
5%
Cambodia Sub-Decree on Personal Data Protection (Sub-Decree No. 134)
2 source controls mapped|10 target controls covered
5%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
2 source controls mapped|5 target controls covered
5%
Brazil Open Finance (Resolução Conjunta No. 1/2020)
2 source controls mapped|7 target controls covered
5%
Lebanon Electronic Transactions and Personal Data Protection Law (Law No. 81/2018)
2 source controls mapped|6 target controls covered
5%
Russia Federal Law on Personal Data (152-FZ)
2 source controls mapped|8 target controls covered
5%
Barbados Data Protection Act 2019
2 source controls mapped|6 target controls covered
5%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|11 target controls covered
5%
Laos Law on Prevention and Combating Cybercrime (2015)
2 source controls mapped|10 target controls covered
5%
Saudi PDPL
2 source controls mapped|8 target controls covered
5%
NIS2 Directive
2 source controls mapped|10 target controls covered
5%
DORA
2 source controls mapped|11 target controls covered
5%
South Korea Credit Information Act
2 source controls mapped|5 target controls covered
5%
ISO/IEC 38500:2024 — Governance of IT
2 source controls mapped|4 target controls covered
5%
EU Energy Performance of Buildings Directive (EPBD Recast) – Draft Directive (2023/0317 COD)
2 source controls mapped|7 target controls covered
5%
Equator Principles (EP4, 2020)
2 source controls mapped|2 target controls covered
5%
Myanmar Cybersecurity Law (2023)
2 source controls mapped|5 target controls covered
5%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
2 source controls mapped|13 target controls covered
5%
Greece Law 4624/2019 — Hellenic Data Protection Authority (HDPA) Implementation Act
2 source controls mapped|7 target controls covered
5%
CIRCIA (Cyber Incident Reporting for Critical Infrastructure Act)
2 source controls mapped|6 target controls covered
5%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
2 source controls mapped|5 target controls covered
5%
EU Code of Conduct for Research Data Management (GDPR Article 40)
2 source controls mapped|6 target controls covered
5%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
2 source controls mapped|7 target controls covered
5%
EU Markets in Crypto-Assets Regulation (MiCA, Regulation 2023/1114)
2 source controls mapped|9 target controls covered
5%
ISO/IEC 29100:2024
2 source controls mapped|6 target controls covered
5%
Kuwait Data Privacy Protection Regulation (KDPPR, 2021 — CMA Directive)
2 source controls mapped|8 target controls covered
5%
UAE Federal Data Protection Law
2 source controls mapped|7 target controls covered
5%
LGPD
2 source controls mapped|9 target controls covered
5%
ISO/IEC 29134:2023
2 source controls mapped|5 target controls covered
5%
ISO/IEC 27014:2020
2 source controls mapped|4 target controls covered
5%
Hungary Act CXII of 2011 on Informational Self-Determination and Freedom of Information (Info Act)
2 source controls mapped|13 target controls covered
5%
Jordan Draft Personal Data Protection Law (2022)
2 source controls mapped|11 target controls covered
5%
USMCA Chapter 19 — Digital Trade (United States-Mexico-Canada Agreement)
2 source controls mapped|2 target controls covered
5%
EU Carbon Border Adjustment Mechanism (CBAM)
2 source controls mapped|8 target controls covered
5%
Kazakhstan Law on Personal Data and Their Protection (No. 94-V)
2 source controls mapped|7 target controls covered
5%
EU Audiovisual Media Services Directive (AVMSD, Directive 2010/13/EU as amended by Directive 2018/1808 and Directive (EU) 2023/2586)
2 source controls mapped|3 target controls covered
5%
EU European Media Freedom Act (EMFA)
2 source controls mapped|9 target controls covered
5%
Uruguay Personal Data Protection Act (Law No. 18.331)
2 source controls mapped|11 target controls covered
5%
ISO/IEC 27557:2022 — Organisational Privacy Risk Management
2 source controls mapped|5 target controls covered
5%
India Account Aggregator Framework (RBI)
2 source controls mapped|2 target controls covered
5%
C-TPAT — Customs-Trade Partnership Against Terrorism
2 source controls mapped|4 target controls covered
5%
ISO/IEC 23837 — Security Requirements for Quantum Key Distribution
2 source controls mapped|3 target controls covered
5%
ASD Strategies to Mitigate Cyber Security Incidents
2 source controls mapped|3 target controls covered
5%
EU AI Liability Directive
2 source controls mapped|6 target controls covered
5%
EU Maritime Single Window Environment Regulation (EU) 2019/1239
2 source controls mapped|10 target controls covered
5%
EU NIS2 Directive — Transport Sector Requirements
2 source controls mapped|4 target controls covered
5%
RICS Professional Standards — Data and Technology in Property
2 source controls mapped|1 target controls covered
5%
ASEAN Data Management Framework
2 source controls mapped|7 target controls covered
5%
Singapore Payment Services Act 2019 (PSA) — Digital Payment Token Provisions
2 source controls mapped|3 target controls covered
5%
Regional Comprehensive Economic Partnership (RCEP) — E-Commerce Chapter
2 source controls mapped|3 target controls covered
5%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
2 source controls mapped|7 target controls covered
5%
NIST Privacy Framework 1.0
2 source controls mapped|7 target controls covered
5%
NIST SP 800-66
2 source controls mapped|3 target controls covered
5%
FTC GLBA Safeguards Rule (16 CFR Part 314)
2 source controls mapped|4 target controls covered
5%
South Africa Promotion of Access to Information Act (PAIA)
2 source controls mapped|3 target controls covered
5%
Nigeria Data Protection Act 2023 (NDPA)
2 source controls mapped|8 target controls covered
5%
Virginia Consumer Data Protection Act (VCDPA)
2 source controls mapped|4 target controls covered
5%
Tonga Communications Act (2015) — Privacy & Data Protection
2 source controls mapped|3 target controls covered
5%
EU Data Governance Act (DGA)
2 source controls mapped|4 target controls covered
5%
South Korea PIPA
2 source controls mapped|6 target controls covered
5%
Bermuda Personal Information Protection Act 2016 (PIPA)
2 source controls mapped|7 target controls covered
5%
UK Open Banking Standard
2 source controls mapped|2 target controls covered
5%
Philippines Data Privacy Act (RA 10173)
2 source controls mapped|9 target controls covered
5%
CFTC System Safeguards (17 CFR 37, 38, 39, 49)
2 source controls mapped|4 target controls covered
5%
GLI-33 — Gaming Laboratories International Event Wagering Systems
2 source controls mapped|4 target controls covered
5%
EIOPA Guidelines on ICT Security and Governance (2023)
2 source controls mapped|3 target controls covered
5%
Telecommunications Sector Security Reforms (TSSR)
2 source controls mapped|3 target controls covered
5%
Oman National Cybersecurity Framework
2 source controls mapped|3 target controls covered
5%
PAS 1192-5:2015 — Security-Minded Approach to BIM and Digital Built Environments
2 source controls mapped|2 target controls covered
5%
Canada ITSG-33 — IT Security Risk Management
2 source controls mapped|2 target controls covered
5%
New Zealand Information Security Manual (NZISM)
2 source controls mapped|2 target controls covered
5%
MARS-E — Minimum Acceptable Risk Standards for Exchanges
2 source controls mapped|2 target controls covered
5%
South Korea Cloud Security Assurance Program (CSAP)
2 source controls mapped|2 target controls covered
5%
NRC 10 CFR 73.54 — Nuclear Facility Cybersecurity
2 source controls mapped|4 target controls covered
5%
ISO 27001:2022
2 source controls mapped|4 target controls covered
5%
AICPA Privacy Management Framework (PMF)
2 source controls mapped|5 target controls covered
5%
PropTech Security Standards — Smart Building Cybersecurity
2 source controls mapped|3 target controls covered
5%
ISO 27799
2 source controls mapped|4 target controls covered
5%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
2 source controls mapped|7 target controls covered
5%
US OFAC Sanctions Compliance Framework
2 source controls mapped|2 target controls covered
5%
DISA Security Technical Implementation Guides (STIGs)
2 source controls mapped|4 target controls covered
5%
Digital Economy Partnership Agreement (DEPA)
2 source controls mapped|3 target controls covered
5%
MARS-E
2 source controls mapped|3 target controls covered
5%
Cook Islands Electronic Transactions Act 2003
2 source controls mapped|6 target controls covered
5%
US Americans with Disabilities Act (ADA) — Title III Digital Accessibility
2 source controls mapped|5 target controls covered
5%
NIST SP 800-124 Rev 2 — Mobile Device Security
2 source controls mapped|3 target controls covered
5%
NIST AI Risk Management Framework (AI RMF 1.0)
2 source controls mapped|6 target controls covered
5%
NIST AI 600-1 Generative AI Profile
2 source controls mapped|7 target controls covered
5%
Israel Protection of Privacy Law (5741-1981)
2 source controls mapped|5 target controls covered
5%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
2 source controls mapped|3 target controls covered
5%
EU Data Act
2 source controls mapped|3 target controls covered
5%
FDA 21 CFR Part 11
2 source controls mapped|4 target controls covered
5%
OWASP Top 10 for LLM Applications 2025
2 source controls mapped|4 target controls covered
5%
ISO/IEC 23894:2023
2 source controls mapped|4 target controls covered
5%
OWASP Top 10:2025
2 source controls mapped|3 target controls covered
5%
OWASP ASVS
2 source controls mapped|2 target controls covered
5%
BSIMM
2 source controls mapped|2 target controls covered
5%
IEC 62351 — Power Systems Communication Security
2 source controls mapped|2 target controls covered
5%
HL7 FHIR Security Framework
2 source controls mapped|3 target controls covered
5%
NIST SP 800-171A Rev 3 — Assessing CUI Security Requirements
2 source controls mapped|4 target controls covered
5%
PCI DSS 4.0
2 source controls mapped|2 target controls covered
5%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
2 source controls mapped|3 target controls covered
5%
ICAO Annex 17 — Aviation Security (AVSEC)
2 source controls mapped|4 target controls covered
5%
California IoT Security Law
2 source controls mapped|2 target controls covered
5%
3GPP Security
2 source controls mapped|2 target controls covered
5%
3GPP 5G Security Architecture (TS 33.501)
2 source controls mapped|4 target controls covered
5%
NIST SP 800-160
2 source controls mapped|2 target controls covered
5%
ISO 22739:2024 — Blockchain and Distributed Ledger Technologies Vocabulary
2 source controls mapped|5 target controls covered
5%
CISA ICS-CERT Advisories and Industrial Control Systems Security Guidelines
2 source controls mapped|5 target controls covered
5%
FBI CJIS Security Policy
2 source controls mapped|5 target controls covered
5%
NIST SP 800-88
2 source controls mapped|2 target controls covered
5%
UK PSTI Act
2 source controls mapped|2 target controls covered
5%
ISO 27043
2 source controls mapped|2 target controls covered
5%
NIST SP 800-181
2 source controls mapped|2 target controls covered
5%
ETSI EN 303 645
2 source controls mapped|2 target controls covered
5%
O-RAN Alliance Security Specifications (O-RAN.WG11)
2 source controls mapped|4 target controls covered
5%
DAMA-DMBOK2 — Data Management Body of Knowledge (2nd Edition)
2 source controls mapped|4 target controls covered
5%
SIG (Shared Assessments)
2 source controls mapped|2 target controls covered
5%
ASD Information Security Manual (ISM)
2 source controls mapped|5 target controls covered
5%
OpenSSF Scorecard
2 source controls mapped|2 target controls covered
5%
NIST SP 800-63
2 source controls mapped|2 target controls covered
5%
NIST SP 800-92
2 source controls mapped|2 target controls covered
5%
NIST SP 800-115
2 source controls mapped|2 target controls covered
5%
NIST SP 800-123
2 source controls mapped|2 target controls covered
5%
ITAR — International Traffic in Arms Regulations
2 source controls mapped|4 target controls covered
5%
PTES
2 source controls mapped|2 target controls covered
5%
NIST SP 800-150
2 source controls mapped|2 target controls covered
5%
NIST Cybersecurity Framework 2.0
2 source controls mapped|2 target controls covered
5%
MITRE D3FEND
2 source controls mapped|2 target controls covered
5%
NIST SP 800-137
2 source controls mapped|2 target controls covered
5%
MITRE ATT&CK
2 source controls mapped|2 target controls covered
5%
SWIFT Customer Security Programme (CSP)
2 source controls mapped|3 target controls covered
5%
OWASP DevSecOps Maturity Model (DSOMM)
2 source controls mapped|6 target controls covered
5%
US NRC 10 CFR 73.54 — Cyber Security for Nuclear Power Plants
2 source controls mapped|3 target controls covered
5%
NIST SP 800-218
2 source controls mapped|2 target controls covered
5%
NIST SP 800-187
2 source controls mapped|2 target controls covered
5%
SLSA
2 source controls mapped|2 target controls covered
5%
UK Gambling Commission — Cyber Resilience Requirements
2 source controls mapped|4 target controls covered
5%
Proposal for a Regulation on Cyber Resilience Act (CRA)
2 source controls mapped|2 target controls covered
5%
ISO 27002:2022
2 source controls mapped|3 target controls covered
5%
UNECE WP.29 R156
2 source controls mapped|2 target controls covered
5%
SSAE 18 SOC 1 — Report on Controls at a Service Organisation (ICFR)
2 source controls mapped|3 target controls covered
5%
ISO/SAE 21434
2 source controls mapped|2 target controls covered
5%
NIST SP 800-128
2 source controls mapped|2 target controls covered
5%
NIST SP 800-207
2 source controls mapped|2 target controls covered
5%
UNECE WP.29 R155
2 source controls mapped|2 target controls covered
5%
PCI DSS v4.0
2 source controls mapped|4 target controls covered
5%
ISO 19650 — Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
2 source controls mapped|4 target controls covered
5%
NIST SP 800-183
2 source controls mapped|2 target controls covered
5%
OWASP SAMM
2 source controls mapped|2 target controls covered
5%
NIST SP 800-161
2 source controls mapped|2 target controls covered
5%
OWASP MASVS
2 source controls mapped|2 target controls covered
5%
SSDF (NIST)
2 source controls mapped|2 target controls covered
5%
ISO/IEC 27006:2024
2 source controls mapped|4 target controls covered
5%
NIST SP 800-61
2 source controls mapped|2 target controls covered
5%
NIST SP 800-82 Rev 3 — Guide to OT Security
2 source controls mapped|3 target controls covered
5%
IAEA Nuclear Security Series — Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
2 source controls mapped|4 target controls covered
5%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
2 source controls mapped|2 target controls covered
5%
CTDPA (Connecticut Data Privacy Act)
1 source controls mapped|5 target controls covered
3%
US EPA Safe Drinking Water Act (SDWA) — Cybersecurity Requirements
1 source controls mapped|3 target controls covered
3%
UK Modern Slavery Act 2015
1 source controls mapped|3 target controls covered
3%
Canada's Anti-Spam Legislation (CASL)
1 source controls mapped|3 target controls covered
3%
Zambia Data Protection Act (2021)
1 source controls mapped|6 target controls covered
3%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
1 source controls mapped|3 target controls covered
3%
Bahrain PDPL
1 source controls mapped|5 target controls covered
3%
APPI
1 source controls mapped|5 target controls covered
3%
COPPA
1 source controls mapped|5 target controls covered
3%
Colorado Privacy Act (CPA)
1 source controls mapped|14 target controls covered
3%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|5 target controls covered
3%
Australia AI Ethics Framework
1 source controls mapped|2 target controls covered
3%
China AI Regulations
1 source controls mapped|2 target controls covered
3%
APEC Cross-Border Privacy Rules (CBPR) System
1 source controls mapped|3 target controls covered
3%
Australian Privacy Principles (APPs)
1 source controls mapped|3 target controls covered
3%
SOX 404 / ICFR
1 source controls mapped|1 target controls covered
3%
CCPA/CPRA
1 source controls mapped|5 target controls covered
3%
Japan APPI
1 source controls mapped|2 target controls covered
3%
Korea PIPA
1 source controls mapped|3 target controls covered
3%
Chile DPL
1 source controls mapped|5 target controls covered
3%
Canada Artificial Intelligence and Data Act (AIDA)
1 source controls mapped|2 target controls covered
3%
Global Cross-Border Privacy Rules (Global CBPR) Forum
1 source controls mapped|3 target controls covered
3%
Switzerland FADP
1 source controls mapped|5 target controls covered
3%
Colorado Privacy Act
1 source controls mapped|5 target controls covered
3%
Privacy Act 1988 (Australia)
1 source controls mapped|5 target controls covered
3%
ASEAN Guide on AI Governance and Ethics
1 source controls mapped|1 target controls covered
3%
Argentina PDPA
1 source controls mapped|5 target controls covered
3%
US Consumer Product Safety Commission (CPSC) — Connected Product Safety
1 source controls mapped|1 target controls covered
3%
ESRB Privacy Certified
1 source controls mapped|6 target controls covered
3%
Brazil AI Framework
1 source controls mapped|2 target controls covered
3%
Customs-Trade Partnership Against Terrorism (C-TPAT)
1 source controls mapped|1 target controls covered
3%
UK Defence Standard 05-138 — Cyber Security for Defence Suppliers
1 source controls mapped|2 target controls covered
3%
Nebraska Data Privacy Act
1 source controls mapped|5 target controls covered
3%
Taiwan PDPA
1 source controls mapped|5 target controls covered
3%
Law No. 172-13 on the Protection of Personal Data
1 source controls mapped|5 target controls covered
3%
Iceland DPA
1 source controls mapped|5 target controls covered
3%
Delaware Online Privacy and Protection Act (proposed)
1 source controls mapped|5 target controls covered
3%
PIPEDA
1 source controls mapped|5 target controls covered
3%
Texas Data Privacy Act
1 source controls mapped|4 target controls covered
3%
Uruguay DPL
1 source controls mapped|5 target controls covered
3%
China PIPL
1 source controls mapped|5 target controls covered
3%
Utah Consumer Privacy Act
1 source controls mapped|5 target controls covered
3%
Indonesia PDP Law
1 source controls mapped|5 target controls covered
3%
IEEE 7000
1 source controls mapped|2 target controls covered
3%
Norway PDPA
1 source controls mapped|5 target controls covered
3%
Minnesota Consumer Data Privacy Act
1 source controls mapped|5 target controls covered
3%
India DPDP Act
1 source controls mapped|5 target controls covered
3%
FERPA
1 source controls mapped|5 target controls covered
3%
Vietnam PDPD
1 source controls mapped|5 target controls covered
3%
New Hampshire Privacy Act
1 source controls mapped|5 target controls covered
3%
PDPA Singapore
1 source controls mapped|5 target controls covered
3%
Montana Consumer Data Privacy Act
1 source controls mapped|5 target controls covered
3%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
1 source controls mapped|3 target controls covered
3%
Malaysia PDPA 2010
1 source controls mapped|5 target controls covered
3%
Tennessee IPA
1 source controls mapped|5 target controls covered
3%
Iowa Consumer Data Protection Act
1 source controls mapped|5 target controls covered
3%
NIST Privacy Framework Version 1.0
1 source controls mapped|4 target controls covered
3%
Kentucky Consumer Data Protection Act
1 source controls mapped|6 target controls covered
3%
Liechtenstein DPA
1 source controls mapped|5 target controls covered
3%
POPIA
1 source controls mapped|5 target controls covered
3%
Peru DPL
1 source controls mapped|5 target controls covered
3%
Qatar DPL
1 source controls mapped|5 target controls covered
3%
Nigeria NDPR
1 source controls mapped|5 target controls covered
3%
ISO 27701
1 source controls mapped|5 target controls covered
3%
Kenya DPA
1 source controls mapped|5 target controls covered
3%
Kenya Data Protection Act
1 source controls mapped|2 target controls covered
3%
Ley Orgánica de Protección de Datos Personales (LOPDP)
1 source controls mapped|5 target controls covered
3%
Saudi Arabia PDPL
1 source controls mapped|5 target controls covered
3%
UK Age Appropriate Design Code (Children's Code)
1 source controls mapped|6 target controls covered
3%
Rwanda DPL
1 source controls mapped|5 target controls covered
3%
Turkey KVKK
1 source controls mapped|5 target controls covered
3%
Oregon Consumer Privacy Act
1 source controls mapped|5 target controls covered
3%
Indiana Consumer Data Protection Act
1 source controls mapped|3 target controls covered
3%
UK Data Protection Act 2018
1 source controls mapped|6 target controls covered
3%
Japan AI Guidelines
1 source controls mapped|2 target controls covered
3%
UNICEF Policy Guidance on AI for Children (2021)
1 source controls mapped|2 target controls covered
3%
China Data Security Law (DSL)
1 source controls mapped|1 target controls covered
3%
Maryland Online Data Privacy Act
1 source controls mapped|3 target controls covered
3%
Virginia CDPA
1 source controls mapped|5 target controls covered
3%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
1 source controls mapped|2 target controls covered
3%
SOC for Cybersecurity — Cybersecurity Risk Management Examination
1 source controls mapped|2 target controls covered
3%
ENISA Privacy-Enhancing Technologies Reports and Recommendations
1 source controls mapped|2 target controls covered
3%
Philippines DPA
1 source controls mapped|5 target controls covered
3%
Jamaica DPA
1 source controls mapped|5 target controls covered
3%
ISO 42001
1 source controls mapped|2 target controls covered
3%
PDPA Thailand
1 source controls mapped|5 target controls covered
3%
New Jersey Data Privacy Act
1 source controls mapped|5 target controls covered
3%
New Zealand Privacy Act
1 source controls mapped|5 target controls covered
3%
Mauritius DPA
1 source controls mapped|5 target controls covered
3%
UK AI Regulation Framework
1 source controls mapped|2 target controls covered
3%
Privacy and Other Legislation Amendment Act 2024 (Australia)
1 source controls mapped|3 target controls covered
3%
Mexico LFPDPPP
1 source controls mapped|5 target controls covered
3%
NIST SP 800-122
1 source controls mapped|5 target controls covered
3%
UAE PDPL
1 source controls mapped|5 target controls covered
3%
Kids Online Safety Act (KOSA)
1 source controls mapped|2 target controls covered
3%
Voluntary Principles on Security and Human Rights (VPs)
1 source controls mapped|1 target controls covered
3%
Hong Kong Personal Data (Privacy) Ordinance (PDPO, Cap 486)
1 source controls mapped|2 target controls covered
3%
SASB Standards (ISSB Integrated)
1 source controls mapped|2 target controls covered
3%
SASB Standards
1 source controls mapped|2 target controls covered
3%
Student Privacy Pledge 2020
1 source controls mapped|4 target controls covered
3%
Singapore AI Governance Framework
1 source controls mapped|2 target controls covered
3%
OECD AI Principles
1 source controls mapped|2 target controls covered
3%
ISO 26000:2010
1 source controls mapped|1 target controls covered
3%
ITU-T X.805 — Security Architecture for End-to-End Communications
1 source controls mapped|1 target controls covered
3%
Nevada Gaming Control Board Cybersecurity Requirements
1 source controls mapped|1 target controls covered
3%
Lloyd's Minimum Standards — Cyber Security
1 source controls mapped|1 target controls covered
3%
FTC Safeguards Rule (16 CFR Part 314)
1 source controls mapped|2 target controls covered
3%
CISA Zero Trust Maturity Model
1 source controls mapped|1 target controls covered
3%
NIST SP 800-171A — Assessing CUI Security Requirements
1 source controls mapped|3 target controls covered
3%
FFIEC Cybersecurity Assessment Tool (CAT)
1 source controls mapped|1 target controls covered
3%
Belgium CyberFundamentals
1 source controls mapped|1 target controls covered
3%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
3%
US Automated Commercial Environment (ACE) — CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
3%
ANSSI Cybersecurity Framework
1 source controls mapped|1 target controls covered
3%
OWASP API Security Top 10:2023
1 source controls mapped|3 target controls covered
3%
Cyber Essentials Plus
1 source controls mapped|1 target controls covered
3%
Authorised Economic Operator (AEO) Programmes — Global Standards
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53 Rev 5
1 source controls mapped|3 target controls covered
3%
ILO Tripartite Declaration of Principles concerning Multinational Enterprises (MNE Declaration)
1 source controls mapped|1 target controls covered
3%
ASD Essential Eight Maturity Model
1 source controls mapped|3 target controls covered
3%
Sigstore — Software Artifact Signing and Verification
1 source controls mapped|1 target controls covered
3%
Saudi NCA ECC
1 source controls mapped|1 target controls covered
3%
CWE Top 25 Most Dangerous Software Weaknesses (2024)
1 source controls mapped|3 target controls covered
3%
NIST SP 800-172
1 source controls mapped|1 target controls covered
3%
FISMA
1 source controls mapped|1 target controls covered
3%
WCO Authorised Economic Operator (AEO) Framework
1 source controls mapped|3 target controls covered
3%
TSA Pipeline Security
1 source controls mapped|1 target controls covered
3%
NIST SP 800-171
1 source controls mapped|1 target controls covered
3%
CNCF Cloud Native Security (Cloud Native Computing Foundation)
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53A
1 source controls mapped|1 target controls covered
3%
DoD Zero Trust Reference Architecture
1 source controls mapped|1 target controls covered
3%
Samoa Telecommunications Act (2005) — Privacy & Data Protection
1 source controls mapped|2 target controls covered
3%
CISA Secure by Design Principles
1 source controls mapped|1 target controls covered
3%
ILO Declaration on Fundamental Principles and Rights at Work (Core Conventions)
1 source controls mapped|1 target controls covered
3%
Ghana Cybersecurity Act
1 source controls mapped|1 target controls covered
3%
TSA Pipeline Cybersecurity Directives
1 source controls mapped|1 target controls covered
3%
Spain ENS
1 source controls mapped|1 target controls covered
3%
EMV 3-D Secure (3DS2) — Payment Authentication Protocol
1 source controls mapped|3 target controls covered
3%
ISO/IEC 29147:2018
1 source controls mapped|3 target controls covered
3%
IFRS 17 — Insurance Contracts
1 source controls mapped|2 target controls covered
3%
NIST SP 800-34 Rev 1 — Contingency Planning Guide
1 source controls mapped|3 target controls covered
3%
BRCGS Global Standard for Food Safety Issue 9
1 source controls mapped|3 target controls covered
3%
SWIFT CSCF
1 source controls mapped|3 target controls covered
3%
SWIFT CSCF v2024
1 source controls mapped|3 target controls covered
3%
CIS Controls v8
1 source controls mapped|7 target controls covered
3%
COBIT 2019
1 source controls mapped|1 target controls covered
3%
AS9100D:2016 — Quality Management Systems for Aviation, Space, and Defence
1 source controls mapped|1 target controls covered
3%
ISO 20000-1
1 source controls mapped|2 target controls covered
3%
ISO 14001
1 source controls mapped|1 target controls covered
3%
ISO 45001:2018
1 source controls mapped|1 target controls covered
3%
ISO 9001:2015
1 source controls mapped|2 target controls covered
3%
ISO/IEC 42001:2023
1 source controls mapped|2 target controls covered
3%
ISO 22301:2019
1 source controls mapped|2 target controls covered
3%
3GPP Security Architecture (TS 33.501 — 5G Security)
1 source controls mapped|5 target controls covered
3%
US Foreign Corrupt Practices Act (FCPA)
1 source controls mapped|1 target controls covered
3%
PCAOB AS 2201 — Audit of Internal Control Over Financial Reporting (ICFR)
1 source controls mapped|3 target controls covered
3%
ISO/IEC 27031:2011
1 source controls mapped|1 target controls covered
3%
Science Based Targets initiative (SBTi) Corporate Standard
1 source controls mapped|2 target controls covered
3%
ISO/IEC 27007:2020
1 source controls mapped|1 target controls covered
3%
ISO 19011
1 source controls mapped|3 target controls covered
3%
ISO 31000:2018
1 source controls mapped|1 target controls covered
3%
21 CFR Part 58 — Good Laboratory Practice (GLP)
1 source controls mapped|2 target controls covered
3%
ISO 13485:2016
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27004:2016
1 source controls mapped|3 target controls covered
3%
ISO/IEC 27050 — Electronic Discovery (Parts 1-4)
1 source controls mapped|1 target controls covered
3%
SQF Code Edition 9 — Safe Quality Food
1 source controls mapped|1 target controls covered
3%
ASIS SPC.1-2009 — Organizational Resilience Standard
1 source controls mapped|1 target controls covered
3%
ISO/IEC 30111:2019
1 source controls mapped|3 target controls covered
3%
APRA Prudential Standard CPS 234 — Information Security (Australia)
1 source controls mapped|1 target controls covered
3%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
1 source controls mapped|1 target controls covered
3%
ISO/IEC 29115:2023 — Entity Authentication Assurance Framework
1 source controls mapped|1 target controls covered
3%
21 CFR Part 211 — Current Good Manufacturing Practice
1 source controls mapped|1 target controls covered
3%
BCBS 239
1 source controls mapped|3 target controls covered
3%
HKMA Cyber Resilience Assessment Framework (C-RAF)
1 source controls mapped|2 target controls covered
3%
TNFD Recommendations
1 source controls mapped|4 target controls covered
3%
FedRAMP High
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53 Rev 5 HIGH
1 source controls mapped|1 target controls covered
3%
IRS Publication 1075
1 source controls mapped|1 target controls covered
3%
FedRAMP Moderate
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53 Rev 5 MODERATE
1 source controls mapped|1 target controls covered
3%
NIST SP 800-53 Rev 5 LOW
1 source controls mapped|1 target controls covered
3%
APRA CPS 234
1 source controls mapped|1 target controls covered
3%
BREEAM — Building Research Establishment Environmental Assessment Method
1 source controls mapped|1 target controls covered
3%
IAIS Insurance Core Principles (ICPs)
1 source controls mapped|1 target controls covered
3%
ISO 56002
1 source controls mapped|4 target controls covered
3%
ISO 41001:2018 — Facility Management Systems
1 source controls mapped|3 target controls covered
3%
ISO 39001:2012 — Road Traffic Safety Management
1 source controls mapped|3 target controls covered
3%
ISO 37002:2021 — Whistleblowing Management Systems
1 source controls mapped|3 target controls covered
3%
ISO 50001:2018 — Energy Management Systems
1 source controls mapped|3 target controls covered
3%
ISO 22313:2020 — Guidance on Business Continuity Management Systems
1 source controls mapped|3 target controls covered
3%
C2M2
1 source controls mapped|1 target controls covered
3%
EDM Council DCAM — Data Management Capability Assessment Model
1 source controls mapped|3 target controls covered
3%
Online Safety Act 2021 (Australia)
1 source controls mapped|3 target controls covered
3%
EU GMP Annex 11: Computerised Systems
1 source controls mapped|3 target controls covered
3%
IEC 62304:2015 Medical Device Software Lifecycle Processes
1 source controls mapped|3 target controls covered
3%
HKMA SPM
1 source controls mapped|1 target controls covered
3%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|2 target controls covered
3%
Japan FSA Cybersecurity Guidelines for Financial Institutions
1 source controls mapped|2 target controls covered
3%
RBI Cybersecurity Framework for Banks
1 source controls mapped|2 target controls covered
3%
Kuwait National Cybersecurity Framework
1 source controls mapped|2 target controls covered
3%
DO-178C / ED-12C — Software Considerations in Airborne Systems
1 source controls mapped|3 target controls covered
3%
ISO 26262:2018 — Functional Safety for Road Vehicles
1 source controls mapped|1 target controls covered
3%
RFC 2350 — Expectations for Computer Security Incident Response (BCP 21)
1 source controls mapped|3 target controls covered
3%
ISO/IEC 25012:2008 — Data Quality Model
1 source controls mapped|2 target controls covered
3%
ISO 22320:2018
1 source controls mapped|3 target controls covered
3%
SANS Incident Handler's Handbook and PICERL Methodology
1 source controls mapped|2 target controls covered
3%
EBA Guidelines on ICT and Security Risk Management (EBA/GL/2024/07)
1 source controls mapped|2 target controls covered
3%
ECSS-E-ST-40C: Space Engineering — Software
1 source controls mapped|3 target controls covered
3%
ITU Radio Regulations and Space Security Standards
1 source controls mapped|1 target controls covered
3%
UK Bribery Act 2010
1 source controls mapped|3 target controls covered
3%
COSO Enterprise Risk Management (ERM) Framework (2017)
1 source controls mapped|2 target controls covered
3%
SWIFT CSP
1 source controls mapped|1 target controls covered
3%
Automotive SPICE (ASPICE) v4.0 — Process Assessment Model
1 source controls mapped|2 target controls covered
3%
ECSS Software Engineering Standards
1 source controls mapped|3 target controls covered
3%
ASIC Cyber Resilience Good Practices
1 source controls mapped|2 target controls covered
3%
EN 50126, EN 50128, and EN 50129 — Railway Applications - Reliability, Availability, Maintainability and Safety (RAMS)
1 source controls mapped|3 target controls covered
3%
WCAG 2.2
1 source controls mapped|1 target controls covered
3%
EU Payment Services Directive (PSD2) – Under Review
1 source controls mapped|3 target controls covered
3%
ISO 20400:2017 — Sustainable Procurement
1 source controls mapped|2 target controls covered
3%
PSD2 SCA
1 source controls mapped|1 target controls covered
3%
FFIEC IT Examination Handbook
1 source controls mapped|1 target controls covered
3%
OSFI B-13
1 source controls mapped|1 target controls covered
3%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
1 source controls mapped|1 target controls covered
3%
PCI SSF
1 source controls mapped|1 target controls covered
3%
AICPA SOC 1
1 source controls mapped|1 target controls covered
3%
Open Banking Security
1 source controls mapped|1 target controls covered
3%
ISO 37000:2021 — Governance of Organizations
1 source controls mapped|3 target controls covered
3%
ISO 14064 — Greenhouse Gas Accounting and Verification (Parts 1-3)
1 source controls mapped|1 target controls covered
3%
MTCS — Multi-Tier Cloud Security (Singapore)
1 source controls mapped|2 target controls covered
3%
IATA Operational Safety Audit (IOSA) Standards Manual
1 source controls mapped|1 target controls covered
3%
UK Building Safety Act 2022
1 source controls mapped|2 target controls covered
3%
W3C Verifiable Credentials (VC) Data Model 2.0
1 source controls mapped|2 target controls covered
3%
French Sapin II Law (Law No. 2016-1691)
1 source controls mapped|1 target controls covered
3%
GLBA
1 source controls mapped|1 target controls covered
3%
ETSI ISG QKD - Quantum Key Distribution
1 source controls mapped|3 target controls covered
3%
NATO STANAG 4774/4778 — Confidentiality Metadata Labels
1 source controls mapped|3 target controls covered
3%
ISO 28001:2007 Supply Chain Security Management
1 source controls mapped|1 target controls covered
3%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
1 source controls mapped|1 target controls covered
3%
IATF 16949:2016 — Quality Management System for Automotive Production
1 source controls mapped|2 target controls covered
3%
PCI P2PE
1 source controls mapped|1 target controls covered
3%
Singapore Cybersecurity Act 2018
1 source controls mapped|1 target controls covered
3%
Cyber Security Act 2024 (Australia)
1 source controls mapped|1 target controls covered
3%
ECB TIBER-EU Framework
1 source controls mapped|1 target controls covered
3%
TIBER-EU (Threat Intelligence-Based Ethical Red Teaming - European Union)
1 source controls mapped|1 target controls covered
3%
IRS Publication 1075 — Tax Information Security Guidelines
1 source controls mapped|1 target controls covered
3%
MAS TRM
1 source controls mapped|1 target controls covered
3%
PCI PIN Security
1 source controls mapped|1 target controls covered
3%
AS9100D — Aerospace Quality Management System
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27003:2017
1 source controls mapped|1 target controls covered
3%
AICPA SOC 3
1 source controls mapped|1 target controls covered
3%
CCSDS 350.0-G-3 — Space Communications Security (Consultative Committee for Space Data Systems)
1 source controls mapped|1 target controls covered
3%
EASA Part-IS — Information Security in Aviation
1 source controls mapped|1 target controls covered
3%
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 16 domains and 37 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 European Union through the Clinical Trials Information System (CTIS). The regulation aims to simplify and streamline the assessment and supervision of clinical trials, ensuring a high level of public health protection and transparency. It became fully applicable on 31 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 37 controls organised across 16 domains. The largest domains are Chapter II — Application and Authorisation (5 controls), Application Process (4 controls), Chapter III — Subject Protection (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 592 other compliance frameworks. The top mapping partners are Connecticut Data Privacy Act (CTDPA) (14% coverage), Florida Digital Bill of Rights (FDBR) (14% coverage), Australia My Health Records Act 2012 (14% 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 37 controls and track your progress.

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