Key Considerations For ICH-GCP Guidance On Quality Risk Management
This Q&A on the ICH-GCP was conducted by Ed Miseta from Clinical Leader in response to Elizabeth’s blog post from December 21.
By now, many of you are probably wondering about the recent adoption of Good Clinical Practices (ICH E6 Guideline, R2). More specifically, you are likely wondering how the ICH-GCP will apply to your own organization.
In this Q&A, Elizabeth Bodi, senior consultant at Halloran Consulting Group, answers some of your questions and sheds some light on the guidance and how it may impact research, resources, and patients.
Ed Miseta: What is the biggest change we might expect to see with the adoption of ICH E6, R2?
Elizabeth Bodi: For many sponsors and CROs, one of the biggest changes is definitely the incorporation of Quality Risk Management (QRM) principles into the design and execution of Clinical Trials. QRM has been around for more than ten years, largely in the manufacturing arena, and outlines the key steps for assessing, controlling, reviewing and communicating risk.
There is a risk assessment stage, which will identify, analyze, and evaluate risk. The risk control stage will accept a certain amount of risk in some areas while attempting to reduce it in others. Finally, a review is performed of the results and output of the entire QRM process. Risk management tools will be used throughout the process, with information communicated at every stage.
Head to Clinical Leader to read the full article.