FDA – ICH E6 R2 Addendum

On March 1, 2018, the Food and Drug Administration (FDA) has announced the availability of the guidance entitled “E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1). “ The guidance amends the guidance entitled “E6 Good Clinical Practice: Consolidated Guidance (E6(R1))” to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The guidance is intended to improve clinical trial quality and efficiency, while maintaining human subject protection and reliability of trial results.