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Compliance checklist grants review constancy
Key is to provide comprehensive structure
The regulatory compliance office at Children's Medical Center of Dallas, TX, has developed a comprehensive, 14-page research compliance checklist that is used to review all studies.
Research compliance is involved, complex, and must follow numerous rules and regulations, so it's helpful to have a checklist for compliance staff to follow, says Barry Rosen, JD, ARM, CHC, CHRC, manager, regulatory compliance, Children's Medical Center in Dallas.
"We had to come up with a list as an objective way to review each clinical trial," Rosen says. "We have reviews that cover multiple trials, but that are focused on narrow issues, and so we'd use elements of the checklist."
The checklist used by the compliance department of Children's Medical Center is in a table format. It's very comprehensive with 17 elements related to informed consent, for instance.
Here are some sample items on the checklist, under the billing section:
–Non-FDA approved with no IDE
–IDE Category A devices (when studying a life-threatening condition)
–IDE Category B devices (when Medicare contractor approves coverage)
–HUD/HDE (Humanitarian Use Device/Humanitarian Device Exemptions)
–Post-marketing approval FDA-required studies
–On-label use of FDA-approved device
–Off-label use of FDA-approved device
Obviously, the elements related to device trials do not apply to studies that involve no devices. But the checklist's chief asset is that it can be applied in general ways to all trials, Rosen says.
"This provides consistency in reviews and helps us document our papers with exactly what we found and didn't find," he says. "We have a way to show what we did to back-up our conclusions."