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integrating more innovative approaches that better ensure human subject protection & data quality

We build quality into clinical research from start to end which supports a dynamic, flexible, and proactive approach to study management and conduct. Quality-by-design (QbD) and risk management are key principles of our Quality Management System framework.

To keep pace with the increasing scale, complexity, and costs of clinical trials and to ensure appropriate use of technology, our team aims to integrate more innovative approaches that better ensure human subject protection and data quality. We strive to enhance the alignment of Quality with Innovation by developing, piloting, and implementing new methods and quality improvements across studies.

Read more about our current initiatives below.

  • The 3-3-3 approach to Risk Assessment and Risk Management (RARM) is a novel paradigm spearheaded by the Center's Quality Team and subsequently adopted by the WCG Avoca Quality Consortium*. When working with research investigators, we utilize the 3-3-3 approach to identify and manage key study risks (see image below). This, in turn, focuses effort on the things that matter most in research - ensuring human subjects protection and reliability of study results.

    *The University of Utah is a member of the WCG Avoca Quality Consortium (AQC) and participates in Avoca Leadership Advisory Boards that establish best practices for the clinical research industry at large.

     

    TIC Quality by Design
  • Monitoring is a critical aspect of study oversight that contributes to public assurance of human subject protection and reliability of study results. Industry guidelines, regulations, and policies are shifting away from one-size-fits-all approaches and moving towards those that are more risk-based.

    We work with research investigators to customize a fit-for-purpose plan to monitor data and manage risks that promote a more dynamic and proactive approach to continuous improvement in study conduct and oversight. Our team utilizes a risk-based strategy that combines varied approaches to monitoring of clinical investigations.

  • ICH GCP encourages implementation of improved, more efficient approaches to clinical trial oversight. One method we apply to studies is to utilize a risk-based approach to managing protocol deviations.

    This approach encourages more efficient oversight that focuses effort on only those issues with a significant or potentially significant impact to human subject protection and reliability of trial results.