Transcription of E3 Implementation Working Group ICH E3 Guideline ...
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E3 Implementation Working Group ICH E3 Guideline ...
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Secretariat, Chemin Louis-Dunant 15, Box 195, 1211 Geneva 20, Switzerland Telephone: +41 (22) 338 32 06, Telefax: +41 (22) 338 32 30 E3 Implementation Working Group ICH E3 Guideline : structure and Content of Clinical Study Reports Questions & Answers Current version dated 7 June 2012 In order to facilitate the Implementation of the E3 Guideline , the ICH Experts have developed a series of Q&As: E3 Q&As Document History Code History Date E3 Q&As Approval by the ICH Steering Committee under Step 4 7 June 2012 Reference ICH E3 structure and Content of Clinical Study Reports November 1995 Last Update : 7 June 2012 E3 Q&As TABLE OF CONTENTS 1. CONTENT AND structure .. 1 2. APPENDICES .. 3 3. TERMINOLOGY .. 4 i Last Update : 7 June 2012 E3 Q&As E3 Questions and Answers 1.
Some in the pharmaceutical industry have expressed concern that the ICH E3 Guidance, Structure and Content of Clinical Study Reports (hereafter, E3), is intended as a
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