Certified Clinical Research Coordinator (CCRC) Practice Exam

What does the new ICH E6 integrated addendum (R2) require sponsors to implement regarding quality management systems?

1. Increased patient monitoring

2. Database management solutions

3. Risk-based approach to study risk identification

4. Regular audit processes

The correct answer is: Risk-based approach to study risk identification

The integrated addendum to ICH E6 (R2) emphasizes a risk-based approach to clinical trials, which is essential for sponsors in managing quality effectively. This approach requires sponsors to identify, assess, and mitigate risks associated with a study proactively. By focusing on the risk factors that could potentially impact the study's quality and integrity, sponsors can prioritize their resources and efforts more effectively, ensuring that critical aspects of patient safety and data reliability are maintained throughout the trial. Implementing a risk-based approach means that sponsors are not only reacting to problems as they arise but are also strategically planning and preparing to handle identified risks before they become significant issues. This proactive management aligns with the overall goal of improving the quality of clinical research while maintaining regulatory compliance and safeguarding participants’ welfare. The other options listed do not align directly with the specific mandates of the ICH E6 (R2) regarding quality management systems. While patient monitoring, database management solutions, and regular audits are important components of clinical research, the core requirement highlighted by the integrated addendum focuses specifically on the application of a risk-based approach to enhance quality assurance in clinical trials.