E6 Good Clinical Practice
E6(R2) Good Clinical Practice (GCP)
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 incorporates 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.
Date of Step 4: 10 November 2016
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
E6(R3) EWG Good Clinical Practice (GCP)
This topic was endorsed by the ICH Assembly in June 2019.
The E6(R3) EWG is working on the revision of the E6(R2) Guideline “Good Clinical Practice” (GCP) with a view to addressing the application of GCP principles to the increasingly diverse trial types and data sources being employed to support regulatory and healthcare related decision-making on drugs, and provide flexibility whenever appropriate to facilitate the use of technological innovations in clinical trials. Additional information may also be found in ICH Reflection Paper on “GCP Renovation”.
Status: Step 1
GCP Draft Principles (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
Stakeholder Engagement (Click the link below for complete guidelines)
Web Conference (Click the link below for complete guidelines)
ICH E5(R3) EWG - Public Web Conference Report - May 2021
*These Guidelines Belongs to ICH website.
ICH E6 Good Clinical Practice Guidelines:
