ICH GCP E6 (R2) Addendum is due to come into effect on the 14 June 2017

ICH GCP E6 (R2) Addendugcp-ich-picm is due to come into effect on the 14 June 2017.  This is the first revision since (R1) which was published in 1996 and the key changes are outlined below.  The objective of this addendum is to harmonise existing guidance from the FDA, EMA and other agencies as (R1) left much room for interpretation. New definitions have been added to the document and the section on Quality management systems has been added/updated. The main updates are in regards to sponsor and investigator responsibilities and risk based monitoring. See our recent blog.

The revisions address many of  the findings of GCP regulatory inspections over the years.  The revised addendum can be viewed here.