On 30 November 2016, the International Conference on Harmonization of Good Clinical Practice, issued amended guidelines
ICH GCP Guidelines
Now is the time to familiarise yourself with the main components of the guidelines, gain an understanding of the new risk management paradigm and the framework that facilitates easier adoption of innovative technologies.
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 these new guidelines.
What are the changes? The addendum focuses on three key areas; technology validation and certification, risk based quality management systems and increased oversight as illustrated below.
- 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
- Investigator/Institution oversight
- Sponsor oversight
- Essential Document Control