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 (R1) Current version dated 6 July 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 E3 Q&As (R1) Correction of minor typographical errors in the Answer to Question 6: Section was replaced by Section in the second and third paragraphs. 6 July 2012 Reference ICH E3 Structure and Content of Clinical Study Reports November 1995 Last Update : 6 July 2012 E3 Q&As (R1) i TABLE OF CONTENTS 1.
sponsors in the development of a report that is complete, free from ambiguity, well organized, and easy to review.” Modifications and adaptations to the structure presented in the Guideline that lead to better display and communication of information are encouraged. The introduction to E3 (page 2) clearly indicates that E3 is to be
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