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Key Considerations for Compliance to the ICH-GCP Guideline (R2): Quality Risk Management

So you’re wondering about the recent adoption of the Good Clinical Practices (ICH E6 Guideline, R2) and how it applies to your organization.  Perhaps one of the biggest changes is the incorporation of Quality Risk Management (QRM) principles to 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 (see diagram 1 below).

At first glance, this may feel like just another set of required tasks and documentation for an already burdened clinical organization. In fact, when done correctly QRM can save time and critical resources in the full clinical trial life cycle; from trial design, conduct, and oversight, to data recording and regulatory reporting. Below are a few points to consider;

Hopefully, you see the benefits of embracing QRM processes in your Clinical organization, especially now that ICH-GCP requires it. So what are the next steps? In our next blog post, we will outline the steps for defining a roadmap to identify, evaluate, control, communicate, review, and report QRM across the various functions and departments within your organization.