An addendum to ICH GCP has been released for public consultation. WC500191488 (ADDENDUM highlighted)[1] copy ICH_logo
To complement the harmonised ICH E6 Guideline, which was finalised in May 1996, this Addendum is proposed to modernise ICH E6 to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality.
In this “Integrated” Addendum, changes were integrated directly into several sections of the parental Guideline.
Refer to:

Deadline for comments:

  • EU = 31 January 2016
  • MHLW = 30 September 2015
  • FDA = 31 January 2016

[Read more…]