ICH GCP guidelines


ICH GCP (R2) 2016 Coming Soon…

In November 2016, the International Conference on Harmonization of Good Clinical Practice, also known as ICH GCP, will issue amended guidance.  It will be mandatory for sponsors, investigators and CROs, that participate in interventional clinical trials in EU, US, and Japan, to follow these amended guidelines.

Now is the time to familiarize yourself with the main components of the proposed guidelines, gain an understanding of the new risk management paradigm and a framework that facilitates more easier adoption of innovative technologies.

View a summary of the changes outlined in the video below.  

Patient Centric Monitoring ICON's risk based, patient focused methodology for the design and execution of an adaptive monitoring strategy already has a quality management system, risk management system and innovative proprietary technology to support implementation of the new guidelines.

What are the changes?
The upcoming addendum focuses on three key areas; technology validation and certification, risk based quality management systems and increased oversight as illustrated below.

 

2016 ICH GCP (R2) summary (excluding 5.18RBM)

Technology

  • System validation and continuity
  • System access and data integrity
  • Certified copies

(Risk based) Quality Management

  • Plan for Risk
  • Control or tolerate Risk and Error
  • Address Significant Non-compliance
  • Communicate and Adapt Plan

Oversight

  • Investigator/Institution oversight
  • Sponsor oversight
  • Essential Document Control