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  | Australia – Clinical Trial Handbook | |
| | Australia – Clinical Trials | |
| | Australia - Code for the Responsible Conduct of Research | |
| | Australia - Ethical Conduct in Human Research (2007) | |
| | Australia – Human Research Ethics Committees | |
| | Australia - Human Research Ethics Handbook | |
| | Australia - National Statement on Ethical Conduct (1999) | |
| | Australia - Report of the 1999 Workshops on Ethical Conduct | |
| | Australia – Revision of NHMRC/AVCC Statement | |
| | Australia – Therapeutic Goods Act 1989 | |
| | Austria – Guidance on Clinical Trial Authorisation & Amendments | |
| | Austria – Notification of Clinical Investigation with Medical Device or In Vitro Diagnostic | |
| | Brazil – Resolution 251 | |
| | Brazil – Resolution 292 | |
| | Brazil - Resolution No 196/96 | |
| | Bulgaria – Clinical Trials SOP - Checklist | |
| | Bulgaria – Clinical Trials SOP2 - Documentation | |
| | Bulgaria – Clinical Trials SOP 3 - Review and Approval of the Correspondence | |
| | Bulgaria – Clinical Trials SOP4 – Current Review after Approval | |
| | Bulgaria - Ordinance No 14 - Clinical Tests of Medicines on People | |
| | Bulgaria Clinical Trials FAQs | |
| | Canada – Canada Tri-Council Policy Statement | |
| | Canada – Clinical Trial Amendments 1024 | |
| | Canada - Clinical Trials Manual | |
| | Canada – Division 5 – Drugs for Clinical Trials | |
| | Canada - Guidance for Clinical Trial Sponsors | |
| | Canada – Inspection Strategy | |
| | Canada – Tri-Council Policy Statement 2010 | |
| | Canada Guidance – Addendum to ICH E11 - Pediatrics | |
| | Canada Guidance - Bioavailability Studies (draft) | |
| | Canada Guidance - Records Related to Clinical Trials | |
| | Canada Guideline - Inclusion of Women | |
| | CE Council of Europe – Additional Protocol – Biomedical Research | |
| | China - Drug Administration Law | |
| | China - Implementation of the Drug Administration Law | |
| | China - Provisions for Clinical Trials of Medical Devices | |
| | China - Supervision and Administration of Medical Devices | |
| | CIS – Model Law on the Protection of Human Rights and Dignity in Biomedical Research | |
| | Council of Europe – Additional Protocol - Biomedicine | |
| | Council of Europe - Convention on Human Rights and Biomedicine | |
| | Czech Republic – Reporting Adverse Reactions (V4) | |
| | Declaration of Geneva | |
| | Declaration of Helsinki (2004) | |
| | Declaration of Helsinki (2008) | |
| | Declaration of Helsinki Changes (2008) (Draft) | |
| | Denmark – Act on Biomedical Research Ethics Committee System and Processing of Biomedical Research Projects | |
| | Denmark – Authorisation for Clinical Investigations of Medical Devices | |
| | Denmark – Ministerial Order No 806 – Consent of Trial Subjects | |
| | Denmark – Research Ethics Committee System (Amendments) | |
| | EC - ENTR/CT2 – Guidance – Applications to Ethics Committees | |
| | EC Directive – Medicinal Products | |
| | EC Directive – Recommendations for Children (Directive 2001/20/EC) | |
| | EC Directive 2003/63/EC | |
| | EC EudraLex - Recommendations on Inspections | |
| | EC F2/BL D R1 2003 Annex 13 – Manufacture of Investigational Medicinal Products | |
| | EC Guidance – Investigational Medicinal Products | |
| | EC Guideline – Serious Adverse Event Reporting for Medical Devices | |
| | EC Regulation – Deferral of Pediatric Investigation Plan | |
| | EC Regulation - Paediatric Studies | |
| | EC Regulation 540/95 – Reporting Non-Serious Adverse Reactions | |
| | EEC Directive 75/318/EEC - Good Clinical Practice | |
| | EEC Directive 75/318/EEC - Pharmacokinetic Studies in Man | |
| | EMEA - GCP Inspectors Working Group | |
| | EMEA - Guideline on Compassionate Use of Medicinal Products | |
| | EMEA – Multiplicity Issues in Clinical Trials | |
| | EMEA CPMP/EWP/1 776/99 – Missing Data | |
| | EMEA Draft Guideline - First-in-Man High-Risk Medicinal Trials (Draft) | |
| | EMEA Guidance – Drug Interactions | |
| | EMEA Guidance - Investigator Signatures on Clinical Study Reports | |
| | EMEA Guidance 115735 2004 – EDI of Reports | |
| | EMEA Guideline - Clinical Trials in Small Populations | |
| | EMEA Guideline - Data Monitoring Committees | |
| | EMEA Guideline – Mitigating Risks in First-In-Human Trials | |
| | EMEA Paper – Healthrelated Quality of Life (HRQL) Measures | |
| | Estonia - Medical Products Act | |
| | Estonia – National Regulations on Ethics and Research | |
| | Estonia – Regulation 17 - Rules of Procedure of Medical Ethics Committee | |
| | Estonia – Regulation 23 - Conducting Clinical Trials | |
| | Estonia – Regulation 26 - Reporting Serious Adverse Events | |
| | EU – Data Protection and Privacy Ethical Guidelines | |
| | EU – Ethical Considerations with the Paediatric Population | |
| | EU – Ethics Reviews | |
| | EU – Guidance for Informed Consent | |
| | EU – Volume 4 Annex 13 R1 - Manufacture of Investigational Medicinal Products | |
| | EU Council of Europe Recommendation R (97) 5 – Protection of Medical Data | |
| | EU Decision 1982/2006/EC –Seventh Framework Programme | |
| | EU Directive 93/42/EEC – Medical Devices | |
| | EU Directive 95/46/EC – Protection of Personal Data | |
| | EU Directive 2001/20/EC – Good Clinical Practice | |
| | EU Directive 2001/83/EC | |
| | EU Directive 2002/58/EC Privacy and Electronic Communications | |
| | EU Directive 2003/94/EC Good Manufacturing Practice | |
| | EU Directive 2004/27/EC – Medicinal Products | |
| | EU Directive 2005/28/EC – Good Clinical Practice | |
| | EU Directive 2007/47/EC – Active Implantable Medical Devices & Biocidal Products | |
| | EU European Commission – Research Ethics in Developing Countries | |
| | EU Group on Ethics – Ethical Aspects of Clinical Research in Developing Countries | |
| | EU Guidance – Clinical Trials Q&A (version 8.0) | |
| | EU Guidance – Medicinal Product Definitions | |
| | EU Guidance CT1 (R1) – Regulatory Framework | |
| | EU Guidance CT1 (R2) – Request for Authorisation | |
| | EU Guidance CT2 (R1) – Clinical Trial Application Format | |
| | EU Guidance CT3 (R2) – Adverse Reaction Reports | |
| | EU Guidance CT4 (R1) - SUSAR | |
| | EU Guidance CT5 - EUDRACT Database (Superseded) | |
| | EU Guidance CT 5.1 - EUDRACT | |
| | EU Guidance F2/BL D (2006) – Clinical Trial Documents Q&A | |
| | EU Guideline F/2 D (2002) – Qualifications of Inspectors (Draft) | |
| | EU Guideline F/2 D 2002 – Inspection Procedures (Draft) | |
| | EU Guidelines – Medical Devices Clinical Evaluation | |
| | Finland - Clinical Investigations on Medical Devices | |
| | Finland – Clinical Trial of Medicinal Products in Human Subjects | |
| | Finland – Medical Research Act (Amended) | |
| | Finland - Medical Research Act 1999 | |
| | Finland – Medical Research Decree (Amended) | |
| | Greece – Guide for Research Ethics Committees | |
| | Hungary – Clinical Trial and Clinical Practice of Investigational Medical Products | |
| | Hungary - Decree 24/200 | |
| | Hungary – National Regulations on Ethics and Research | |
| | Iceland - Regulation on Clinical Trials | |
| | Iceland – Regulations on Scientific Research in the Biomedical Field | |
| | Iceland - Scientific Research in the Health Sector | |
| | India – Drug & Cosmetics Laws (extracts) | |
| | India – Drugs & Cosmetics Act (Amended 2005, Excerpts) | |
| | India - Ethical Guidelines for Biomedical Research on Human Participants | |
| | India - GCP Guidelines | |
| | International Code of Medical Ethics (Amended 1983) | |
| | Ireland – Clinical Trial Regulations | |
| | Ireland – Control of Clinical Trials Act 1987 | |
| | Ireland – Control of Clinical Trials Act 1990 | |
| | Ireland – Guidance on Operational Procedures for Research Ethics Committees | |
| | Ireland – Guide for Ethics Committees on Clinical Investigation of Medical Devices | |
| | Ireland - S.I. No. 190/2004 - Clinical Trial Regulations | |
| | Israel - Guidelines for Clinical Trials | |
| | Italy – Conduct of Clinical Trials | |
| | Italy – Legislative Decree 211 (2001/20/EC) | |
| | Latvia – National Regulations on Ethics and Research | |
| | Latvia – Regulations on Clinical Trials | |
| | Lithuania – Law on Ethics of Biomedical Research | |
| | Lithuania – Law on Ethics of Biomedical Research | |
| | Malaysia - Guidelines for Good Clinical Practice | |
| | Malaysia – Guidelines to Conduct Clinical Trials | |
| | Malta - Medicines Act 2003 | |
| | Malta – National Regulations on Ethics and Research | |
| | Netherlands – Clinical Research with Medicinal Products | |
| | Netherlands - External Review Directive | |
| | Netherlands - External Review Directive Explanatory Notes | |
| | Netherlands - Medical Research Act | |
| | New Zealand – Ethical Guidelines for Intervention Studies | |
| | Norway – Guidelines for Research Ethics | |
| | Norway - Regulation relating to clinical trials | |
| | Nuremberg Code | |
| | Poland – Regulations on Ethics and Research | |
| | Romania - Good Clinical Practice (anexa_OMSP_904_2006) | |
| | Romania - Order on Good Clinical Practice (OMSP 904 2006) | |
| | Romania – Regulations on Ethics and Research | |
| | Romania – Testing of Medical Products | |
| | Romania 906/2006 – Testing Medicinal Products | |
| | Russia - Clinico-Economic Studies | |
| | Russia - Russian Federation Federal Law on Medicinal Products | |
| | Scotland - Research Governance Framework | |
| | Serbia – Regulation on Clinical Testing of Medicinal Products, Documentation for Authorising | |
| | Singapore - Clinical Evaluation Study Group 5 | |
| | Singapore - Clinical Evidence Key Definitions and Concepts | |
| | Slovak Republic – Regulations on Ethics and Research | |
| | Slovenia – Regulations on Ethics and Research | |
| | Sweden – Background and Regulations | |
| | Sweden - Central Ethical Review Boards | |
| | Sweden - Ethical Review of Research | |
| | Sweden – Ethical Review of Research | |
| | Sweden – Ethical Vetting of Research | |
| | Sweden - Provisions and Guidelines | |
| | Sweden – Regional Ethical Review Boards | |
| | Sweden - trials of medicinal products for human use | |
| | Sweden - What is Subject to Review? | |
| | Switzerland - 812.214.2 Ordinance on clinical trials | |
| | Switzerland – Clinical Trials of Medical Devices | |
| | Switzerland - Guide to the Regulation of Medical Devices | |
| | Turkey – Regulation on Clinical Trials | |
| | UK – Clinical Trials Amendments (2006/1928) | |
| | UK - Clinical Trials Regulations (2004/1031) | |
| | UK - Clinical Trials Regulations (2006/2984) | |
| | UK – Fees and Charges (2004/1157) | |
| | UK – mCTA Clinical Trial Agreement | |
| | UK- mCTA Guidance on Model Clinical Trial Agreement Guidance | |
| | UK – mCTA Tripartite Clinical Trial Agreement (CROs) | |
| | UK – mCTA Tripartite Model Clinical Trial Agreement (CROs) Guidance | |
| | UK - Medicines for Human Use (Clinical Trials) Regulations 2004 | |
| | UK – Mental Capacity Act – Explanatory Memo (2006/3474) | |
| | UK – MOU on Clinical Trials Regulations 2004 | |
| | Ukraine – Procedure for Conducting Clinical Trials and Expert Evaluation of Materials | |
| | UNESCO Universal Declaration on Bioethics and Human Rights | |
| | WHO – Clinical Safety Data Management | |
| | WHO – SOPs for Clinical Investigators | |
| | WHO Guideline TDR/PRD/Ethics/2000.1 – Ethics Committees | |
| | WMA - Medical Ethics Manual | |
| | WMA - Workgroup Report on the Revision of Paragraph 30 of the Declaration of Helsinki | |
