3 May 2012

In April 2012, the ICH E14 Implementation Working Group (IWG) finalised under Step 4 of the ICH Process four additional Questions and Answers addressing Sex Differences, Incorporating New Technologies, Late Stage Monitoring and Heart Rate Correction. This new Q&As were added to the existing topics finalised by the E14 IWG in June 2008 and the Q&A document was renamed R1.

The updated E14 Q&A document is available for download from the E14 Section on the Efficacy Guideline page.