Released by the International Council on Harmonisation (ICH) in November 2016, Good Clinical Practice’s second revision, R2 has been making waves in the clinical research industry.
In March 2018, the US FDA released E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry. A comprehensive comparison of the FDA Guidance against the ICH release reveals only slight clerical and administrative differences, with no major impact on how the ICH release has been interpreted ahead of the FDA Guidance released this month.
ICH E6 R2 was introduced to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight recording and reporting while continuing to ensure human subject protection and reliability of clinical trial results.
The addendum introduces 26 new items, some related to sponsors, some to sites and some to both.