21 June 2012

In June 2012, the ICH E3 Implementation Working Group finalised under Step 4 of the ICH Process a set of Questions and Answers addressing Content and Structure, Appendices and Terminology questions. This supplementary Questions and Answers document intends to clarify key issues which were identified since the ICH E3 Guideline was published in the three ICH Regions.

The ICH E3 Q&As document is available for download from the E3 Section on the Efficacy Guideline page.