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Yale's QI self-assessment tool assists with better site compliance
It also helps with internal audits
Many clinical research institutions have limited resources for internal audits or quality improvement (QI) checks, so the key is to create proactive tools and policies to improve overall site regulatory compliance.
Yale University of New Haven, CT, has mastered this strategy through its creation of a quality improvement self-assessment tool and checklist.
There only are enough staff resources for about seven quality improvement reviews per quarter, says Tracy Rightmer, JD, CIP, compliance manager of the human research protection program at Yale University.
"So we focus on smaller, investigator-initiated studies, federally-funded studies, and others that are not industry-sponsored because those have outside organizations that monitor their activities," she explains.
The studies selected for audits are randomly chosen, based on criteria of greater-than-minimal risk.
The compliance office recommends that researchers improve their processes before a QI visit by completing a self-assessment tool. This tool also serves as a way to educate investigators and research staff on what is expected of them in terms of regulatory documentation, IRB documentation, subject recruitment procedures, informed consent process, subject selection criteria, adverse event reporting, drug/device dispensing accountability, and case report form source documents.
The regulatory documentation section includes references of specific regulations to which the questions pertain. Here are some examples of the self-assessment tool's questions about regulatory documentation:
The point of quality assurance visits is to help investigators and clinical research staff with their documentation and compliance, Rightmer notes.
"We give them an idea of what to expect during the visit, and this reduces some anxiety," she adds. "This is something we do to help them with the process and to work collaboratively to ensure all safeguards for the protection of human subjects are being followed."
The QA reviews are time-consuming and involved, but can be made easier for both the site and QA coordinator if the site has been conducting its own internal audits and monitoring. The self-assessment tool provides a simple structure for doing this. For instance, the self-assessment checklist gives investigators prompts on what is required in subject recruitment procedures, the informed consent process, and subject selection criteria. Here are the checklist questions for these three areas:
Typically, CT sites receive a short report with recommendations following the QA visit.
"We'll provide them with templates with enrollment logs and inclusion/exclusion criteria checklists, and things like that," Rightmer says. "Depending on the findings, we will require corrective actions and a time line for completing those corrective actions."
There is a follow-up to make sure those corrective actions have been completed, she adds.