This booklet contains the Integrated Addendum to ICH GCP E6 (R1): Guideline for Good Clinical Practice E6 (R2) published as a step 4 document in November 2016 which is copyright of the International Council for Harmonisation (ICH). It has been reset from the original version published by ICH on its website and published under public license.
"synopsis" may belong to another edition of this title.