Association of Clinical Trials Organizations (ACTO) –
non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia.

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Home Page

Regulatory Documents

Russian

Federal Law on Medical Products No.86-FZ

International

Consolidated Guideline for Good Clinical Practice (ICH E6)
Declaration of Helsinki
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001
Commission Directive 2005/28/EC of 8 April 2005
Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)
Structure and Content of Clinical Study Reports (ICH E3)
Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Re

Analytics & Media

Structure of CT market

Projects

© Association of Clinical Trials Organizations (ACTO), 2008-2010