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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 Guidance – Investigational Medicinal Products (IMPs) and Non Investigational Medicinal Products (NIMPS) (Rev 1) 
 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 
 Macedonia – Law on Medicinal Products and Medical Devices III.2 
 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 
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