For researches
- Law of Ukraine «About Medicines», 1996 (Law)
- Guidelines «Drugs. Good Clinical Practice. ST-H MoH 42-7.0: 2008», approved by the MoH of Ukraine from 16.02.2009 № 95, with amendmentsGuidelines «Drugs. Good Clinical Practice. ST-H MoH 42-7.0: 2008», approved by the MoH of Ukraine from 16.02.2009 № 95, with amendments.
- Guidelines «Drugs. Investigation of Bioequivalence”, approved by the MoH of Ukraine from 12.01.2017 № 22
- Declaration of Helsinki (2013)
- Directive 2001/20 / EC of the European Parliament and of the Council of the EU of April 04, 2001 (as amended) “On approximation of laws, regulations and administrative provisions of the Member States concerning the introduction of appropriate clinical practice in conducting clinical trials of medicinal products for human consumption”)
- Guideline for Good Clinical Practice. ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
- CIOMS International Ethical Guidelines for Health-related Research Involving Humans
- Code of Federal Regulations45 CFR 46. Protection of Human Subjects
- Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research
For Ethics Committee members
Documents and guidelines
- «Model Regulations of the Ethics Committees at health care settings which conduct clinical trials», approved by order of the MoH of Ukraine №690 from 23.09.2009, with amendments
- Manual «General principles of organization of Ethics Committees activity at health care setting running clinical trials”
- Declaration of Helsinki (2013)
- Directive 2001/20 / EC of the European Parliament and of the Council of the EU of April 04, 2001 (as amended) “On approximation of laws, regulations and administrative provisions of the Member States concerning the introduction of appropriate clinical practice in conducting clinical trials of medicinal products for human consumption”)
- Guideline for Good Clinical Practice. ICH Harmonised Guideline Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
- CIOMS International Ethical Guidelines for Health-related Research Involving Humans
- Code of Federal Regulations45 CFR 46. Protection of Human Subjects
- Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research
- Council of Europe. Guide for Research Ethics Committee Members Steering Committee on Bioethics
- WHO. Guidance document. Standards and operational guidance for ethics review of health-related research with human participants
Organizations
Training materials
Useful links: