Last month, Nicole Tosun, MS, CCRP, gave a presentation on a continuous process improvement approach at the national annual Society of Clinical Research Associates (SOCRA) conference.
The annual SOCRA conference, held in Chicago this year, welcomes professionals in the clinical research field from all over the world for three days of trainings, presentations, workshops, and more.
Tosun, a Senior Clinical Research Specialist who’s part of the University of Minnesota’s Clinical Research Support Center (CRSC), presented “Feedback, Analysis and Action: A High-Power Mechanism for Continuous Improvement.”
This presentation focused on showing fellow research professionals how simple, repeatable processes of improvement can create real, meaningful, ongoing change in almost any research context.
An award-winning service
Tosun has specialized in clinical trial operations and study start-up for over 15 years, leading initiatives to optimize feasibility review processes, enhance stakeholder collaboration, and improve study readiness.
She also plays a key role in one of the Clinical Research Support Center’s signature services: the feasibility review.
Developed in 2018, this award-winning service assembles an expert panel to thoroughly review a researcher’s study protocol, delivering feedback and improvement suggestions within a week.
The Clinical and Translational Science Institute leads the day-to-day operations of these reviews, and is one of a number of collaborators behind the Clinical Research Support Center.
As a senior research specialist, Tosun is part of the team that manages and facilitates meetings with study teams to review their submissions. As such, she has seen how important and powerful a culture of collaboration and continuous improvement can be.
The power of continuous improvement
“Continuous improvement is a culture-driven approach,” Tosun said in her oral presentation at the SOCRA conference. “One that engages an entire organization in making small, frequent, and ongoing changes.”
These small but continuous changes can ultimately reduce waste, improve efficiency, enhance the quality of a study or an organization’s performance, and more.
“What’s important here is that continuous improvement doesn’t rely on a single breakthrough. Instead, it’s about taking many small, intentional steps.”
Each of these steps, or small changes, then builds on the last, creating both momentum and large, long-term impact.
Tosun and team applied this “Feedback, Analysis and Action” model to the feasibility review process, and shared the results with conference attendees.
She described how the team continuously seeks feedback from feasibility review participants, which then directly influences how the review process is changed, modified or otherwise improved moving forward.
Study team satisfaction
An overall satisfaction score of 4.8 out of 5 demonstrates that University of Minnesota researchers find value in the feasibility review approach and culture of continuous improvement.
This loop between reviewers and reviewees creates a system not only of continuous improvement but also continuous support. Study teams who go through the feasibility review process leave feeling seen and heard, and are more likely to come back for study reviews in the future.
Gathering experts on various aspects of clinical research that are dedicated to continuous improvement was key to creating the award-winning feasibility review process.
“The range of expertise in the room is one of our biggest strengths,” says Tosun. “This means we catch things a single reviewer might miss.”
As one review participant stated in a survey, “I’ve been writing IRB protocols for years, and this is the most educational and supportive experience I’ve had.”
Feasibility reviews are free for investigators and study teams, and can be arranged by contacting the Clinical Research Support Center.
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