Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 116

1 1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Integrated Addendum to ICH E6(R2):Guideline for Good Clinical Practice, E6(R2) (2016). Current Step 4 version dated 9 November 2016. https://www.ich.org/page/efficacy‐guidelines

2 2 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A (1994) Current Step 4 version dated 27 October 1994. https://www.ich.org/page/efficacy‐guidelines

3 3 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Guideline for Structure and Content of Clinical Study Reports E3 (1995). Current Step 4 version dated 30 November 1995. https://www.ich.org/page/efficacy‐guidelines

4 4 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Implementation Working Group ICH E3 Guideline: Structure and Content of Clinical Study Reports Questions & Answers (R1) Current version dated 6 July 2012. https://www.ich.org/page/efficacy‐guidelines