How can clinical trial sites decrease the most common noncompliance issues cited in regulatory inspections? It’s a big challenge to sites of all types, and one with major impacts on the safe, ethical, and efficient conduct of life-enhancing drug and device studies.
Tackling this topic in a presentation on “Detecting and Addressing the Quality Pitfalls at Study Sites” at the ACRP 2025 conference next April in New Orleans, La., will be ACRP Fellows Jerry M. Stein, PhD, ACRP-CP, ACRP-MDP, FACRP, President of Summer Creek Consulting, LLC, and Suheila Abdul-Karrim, CCRA, ACRP-MDP, MICR CSci, RQAP-GCP, FACRP, an Independent Clinical Research Consultant.
“The first part of our presentation will define the problem,” says Abdul-Karrim, who is also a member of the ACRP Board of Trustees. “The types and frequency of regulatory inspection findings have not changed significantly in the past decade. Every year, we learn that lack of investigator oversight and nonadherence to protocol requirements are two of the more common noncompliance issues. We will connect the dots: what do these observations have in common and can these patterns help us develop mitigations?”
The second part of the presentation will focus on the root causes for noncompliance and recommend simple actions that sites can implement, says Stein. “One cause is the length, structure, and complexity of most clinical protocols; factors that make study site compliance especially challenging,” he notes. “Their formats are mandated by international regulatory committees and not under the complete control of sponsors. As a result, the typical protocol is very long and very complex. Receiving input from study sites is often a secondary concern.”
Reducing errors when executing complicated procedures is a common problem not unique to clinical evaluations, nor just a modern-day problem, Stein and Adbul-Karrim point out.
Detecting and Addressing the Quality Pitfalls at Study Sites
Join Suheila and Jerry at ACRP 2025 [April 24-27; New Orleans, La.], where they will discuss common inspection findings and how to spot the pitfalls that sites need to address in order to ensure compliance in conduct, performance, and overall execution of clinical trials. View complete schedule.
“Improving performance has been successfully addressed in hundreds of industries tasked with managing unfamiliar, complex, and risky tasks,” Stein explains. “The key is to address the topic head-on for the betterment of everyone involved in clinical trials, and especially for the sake of the volunteer participants.”
“We believe the key to improving compliance is addressing the structure of protocols, adjusting training plans, and providing sites with better tools,” Adbul-Karrim says. “In this way, site staff and leaders are not doomed to keep repeating the mistakes of the past, but can move into a greatly improved future with confidence.”
Edited by Gary Cramer
