2 July 2017 Off By simone

Good Clinical Practice (GCP)

The tripartite harmonised ICH Guideline was finalised under Step 4 in May 1996. This Good Clinical Practices document describes the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCPs cover aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator’s Brochure which had been agreed earlier through the ICH process.

The document titled Good Clinical Practice is archived by the ICH with the code E6(R1): Good Clinical Practice – E6(R1), where E6 stands for “Efficacy Guidelines 6” and R1 stands for “Revision 1”. In November 2016 ICH published a finalized integrated addendum of GCP-E6(R1), the so called Step 5, Good Clinical Practice – E6(R2).

ICH Guidelines

The ICH topics are divided into four categories (Quality, Safety, Efficacy, and Multidisciplinary) and ICH topic codes are assigned according to these categories. Furthermore with the new codification revisions to an ICH Guideline are shown as (R1), (R2), (R3) depending on the number of revisions.