“We’re always talking about quality, but it’s more than a buzzword,” says Wendy Troccio, a trial regulations and compliance expert based in Chicago. The difference today? More and more trial practitioners “realize you have to have a plan based on standards and federal regulations,” she explains.
That said, any effective program must be tailored to a specific trial operation, Troccio adds. There are any number of quality management plans out there and, in many cases, she says, those have successfully reduced the number of U.S. Food and Drug Administration (FDA) consider to be violations, but “we’ve also learned that each site should have its own quality plan.”
Unfortunately, sites too often follow a “do it fast, do it today” destructive mantra that creates big problems down the road, Troccio says. Some practitioners tell themselves that they’ll go back and “fix” the quality program “when things slow down,” she adds. “That slow down period never comes.”
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The problems start when a trial sites hears an auditor knock at the door, Troccio says, or the sponsor wants to pop in for a monitoring visit. That’s when “you realize you forgot to go back” and make those important fixes, she notes. “You’ll see you did a horrible job and the quality is severely impacted.”
The consequence? “That’s reflected in the letter the investigator gets, [and when an FDA investigation] goes against the [study] investigator, it goes against the site,” Troccio says.
In today’s competitive market, “you have to have a plan with quality built right into it,” Troccio says. It’s isn’t always easy. “Each and every day, every person on that research team [should be doing] the same thing [according to the plan]—it is standardized—whether or not you expect an FDA audit,” she adds.
A successful quality management plan is based on some simple tenets: “Say what you do, do what you say, prove it, then improve it,” Troccio says.
The quality management plan should spell out everything you do in your program. “You have to make sure that your research personnel, including the investigators, are” following the plan closely, Troccio adds. Big benefit? “You are audit-ready any day,” she explains.
Author: Michael Causey