Regulatory Science Symposium “Quality by Design in Clinical Trials” Session 7: Wrap-Up (2020)

In this series, we will discuss the principles of quality by design.


  1. Monitoring Module & Clinical Research Professional Training
  2. Quality by Design Takeaway: Plan, Do, Act, Check
  3. Audience Polling:
  • I would be interested in pursuing an MS degree in Clinical Research Design and Management.
    • Ans: 22% answered Yes. 47% answered Maybe. 31% answered No.
  • After today’s symposium, I feel that I have a good basic understanding of QbD principles.
    • Ans: 86% answered Yes. 14% answered Neutral.
  • “Quality” in clinical trials is defined as:
    • Ans: The absence of errors that matter to decision making.
    • Explanation: Although ensuring that the trial is conducted according to GCP, protocol, SOP, and other regulatory requirements are important in clinical trials, QbD is mainly focused on the absence of errors that matter to decision making.
  • Why is quality by design important?
    • Ans: It prospectively examines the objectives of a trial and define factors critical to meeting these objectives.
  • Three key principles of quality science include quality of end product, culture of productivity, and focus on consumer feedback.
    • Ans: False
    • Explanation: Culture productivity is not what we want to emphasize as a key principle of quality science. We want to focus on a culture of quality by identifying critical to quality factors, instead of productivity. Quality of the end product is not a cultural quality. One should include the cultural quality during the process rather than testing for it at the end.
  • Which of the following is NOT a QbD recommendation from CTTI?
    • Ans: Focus on creating useful tools and checklists - QbD by CTTI is not advising research professionals to focus on tools and checklists but instead on credibility of outcomes, protocol development, and identifying and reviewing the quality factors.
  • What is an example of a factor critical to quality?
    • Ans: Design of the study protocol - It is important to impact the factors critical to quality at the very beginning as you design the study protocol, determine eligibility criteria, study procedures, and end points.
  • Understanding what is critical to quality results in a focused monitoring and auditing plan.
    • Ans: True - Understanding what are the critical to quality factors allows you to have a risk-based monitoring and auditing plan and a better understanding of the elements that are important to control and to verify.
  • What is not a barrier to QbD implementation?
    • Ans: All of the above are barriers: difficulty overcoming organizational inertia, fear of change, concern it would take more time and create more work, lack of understanding in QbD value.

4. Closing Remarks:

  • The incorporation of Quality by Design within the conduct of clinical trials is a relatively new concept. We will continue to reinforce and integrate this concept into our future offerings.


Accompanying text created by Ashwini Tambe | Graduate Student, Regulatory Science, USC School of Pharmacy |


Eunjoo Pacifici, PharmD, PhD
Chair and Associate Professor of Regulatory and Quality Sciences Associate Director, D. K. Kim International Center for Regulatory Science

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.