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;

• We are not starting from scratch. The ICH Q9 Guidance Document provides step by step guidance for setting up and executing QRM and provides useful tools for assessing and documenting risk.
• We are not the first to utilize QRM. As noted above, manufacturing has been following QRM principles for more than ten years. We have colleagues, consultants, articles, and best practices to get us quickly up the learning curve.
• The foundation of QRM is to ensure patient/subject safety – and that’s what we do every day in Clinical. QRM just provides a logical step-wise process for doing what we have always done in Clinical.
• QRM forces up front discussion and evaluation of risk, ensuring a proactive rather than reactive approach to risk management. The sooner risk can be identified, the easier it is to address and resolve, saving time and resources at the back-end.
• QRM allows Clinical leadership to focus resources on the highest risk areas and therefore utilize staff more efficiently and effectively.
• Enterprise-wide use of QRM means Senior Management can roll up risk across the entire development lifecycle, leading to better budget and timeline projections as well as making informed go/no-go decisions.
• Demonstrated adherence to QRM provides assurance to regulatory agencies that risks are being minimized. The may lead to fewer/shorter inspections.

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.