GCP Module Updates for ICH E6(R2) Guideline

CITI Program's Interactive Plagiarism Module

On 15 December 2016, the International Council for Harmonisation (ICH) adopted the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), which reflects the evolving modernization of research (such as increases in globalization, study complexity, and technological capabilities of clinical trials). Researchers, sponsors, and IRB members who comply with ICH E6 should be aware of the new guideline.

CITI Program GCP courses reflect the changes from ICH E6(R2)

After the ICH E6(R2) guideline was adopted, CITI Program's GCP modules that reference ICH E6 were revised to reflect the updated guideline. These GCP modules now specifically refer to the current guideline.

Learn more about the ICH E6 guideline in the Final Concept Paper on the Addendum for ICH E6 and the ICH webinar on the ICH E6 addendum.

Overview of ICH GCP E6(R2) Revisions Module

This module reviews the additions that led to the publication of the ICH E6(R2) guideline and discusses the new approaches for the management of clinical trials – including quality management, risk-based monitoring, and data integrity. Subscribing organizations may add this module to GCP courses.

CITI Program has updated all affected GCP Modules in the following courses: 
  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
  • GCP - Social and Behavioral Research Best Practices for Clinical Research
  • GCP FDA Refresher
  • GCP ICH Refresher
  • GCP SBR Advanced Refresher
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Last Updated: 30-Jan-2019 1:16 p.m. EST
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