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The SC CTSI is launching a new program to promote successful execution of clinical research studies. The program combines an established quality framework called Quality by Design (QbD) with team building and project management to help research teams meet their project timelines and overcome any barriers. 

GOALS: To optimize projects’ scientific and operational design and conduct to maximize the impact of our clinical research. 

CURRENT ACTIVITIES: SC CTSI is beginning to apply the QbD program to our high-investment projects, such as pilot awards and projects for KL2 Scholars. We are also making QbD resources available to other teams. Resources include tools created by the Clinical Trials Transformation Initiative as well as SC CTSI consultations and educational opportunities and resources (see below). Because SC CTSI supports a wide range of research, we will also provide resources for study types beyond traditional clinical trials, including community and healthcare delivery research. 


QbD Launch Studios

The QbD process begins with a “QbD Launch Studio” for a chosen study. The studio includes a presentation of the protocol, followed by a systematic review of the factors in the QbD Principles Document. Questions will be designed to spark critical evaluation of the factors driving quality in the project, such as: “Are the endpoints commensurate with the objectives of the study?” and “Are all eligibility criteria relevant to ensuring the specific subject population needed for the trial?” The outcome of the Studio will be a finalized protocol with a project management plan.

Participants at the Launch Studios will be tailored to the specific project, but in general will include critical members of the project team plus SC CTSI members of team science, BERD, informatics, clinical research support, and at least one community member. QbD Specialists are SC CTSI staff that have been trained in QbD methods and form the core workforce for direct application of QbD principles and processes to specific SC CTSI supported projects.

QbD Education

Workshops and consultations offer the broader USC and CHLA community a chance to learn Quality by Design principles and incorporate the framework into their research. A full-day Regulatory Science symposium introduced QbD to over 100 clinical research professionals. Stay tuned for more QbD training opportunities.

QbD Resources

Launch Studio agenda

Project Planning Template (coming soon)

Questions about the initiative

Allison Orechwa
Senior Director of Strategy and Innovation; Interim Program Manager, Healthcare Delivery 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.