The Institute of Behavioral Research (IBR) is shifting from reacting to compliance problems to preventing them, an approach Crystal Moran, public health research associate for regulatory compliance at IBR, presented at the Society of Clinical Research Associates (SOCRA) Annual Conference in Denver.
Her poster, “From Reactive to Proactive: Applying the Plan-Do-Study-Act Framework to Build an Audit-Ready Research Compliance Program at the IBR,” was delivered to clinical researchers and research compliance professionals at a conference that also focused on the growing use of artificial intelligence in research.
Moran explained how IBR used the Plan-Do-Study-Act (PDSA) model, a continuous quality improvement framework, to identify gaps in its compliance processes, define desired outcomes and test strategies for improvement. Research programs that standardize their regulatory processes see more organized and consistent documentation, greater visibility into compliance activities and stronger audit readiness, she said.
For IBR, that preparation reduces the risk of documentation deficiencies, protocol deviations and violations.
“My role at the IBR isn’t to be the audit police or come out from hiding saying ‘gotcha!’” Moran said. “I am in this role to support the IBR as a whole and prepare us for any potential auditing that could take place by standardizing compliance processes so that everyone is on the same page if the day ever comes.”
By standardizing compliance processes across the institute, IBR aims to ensure its researchers and staff are prepared for any future audits.
