• E6 Good Clinical Practice

    Code Document Title Previously coded
    • Finalised Integrated Addendum: November 2016

      Description :

      The first version of the ICH E6 Good Clinical Practice (GCP) Guideline was finalised in 1996 describing the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors and IRBs. GCP covers aspects of monitoring, reporting and archiving of clinical trials and incorporating addenda on the Essential Documents and on the Investigator's Brochure.

      This harmonised guideline has been amended in 2016 with an integrated Addendum 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 trial results. Standards regarding electronic records and essential documents intended to increase clinical trial quality and efficiency have also been updated. 

      Implementation :

      Step 5


      EC, EuropeAdopted by CHMP, 15 December 2016, issued as EMA/CHMP/ICH/135/1995


      MHLW/PMDA, Japan To be notified


      FDA, United States Published in the Federal Register, 1 March 2018, Vol. 83, No. 41, p. 8882-3


      Health Canada, Canada To be notified


      Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website