An effective corrective and preventive action (CAPA) plan for clinical trial practitioners focuses like a laser on a protocol deviation’s root cause by relentlessly asking “why did something happen,” says Mindy Ditch, MS, president and founder of Bloom Clinical Research, LLC. Unfortunately, when tasked with the challenge, some people are “intimidated” as they try to come up with a workable CAPA program, she adds.
Part of the problem stems from overcomplicating the issue, says Ditch, who will present a session delving into all things CAPA during the September segment of the ACRP 2021 virtual conference. “It’s time to demystify CAPA and the CAPA process,” she advises. “Put it in simple terms and make it less intimidating.”
It begins with dispensing with the “CAPA” acronym for a moment and taking a step back to look at what it stands for. “CAPA is about understanding why something happened and preventing it from happening again,” she says. It’s literally focused on corrective and preventative action in response to instances of noncompliance with trial protocols, rather than a more nebulous and complicated task, she adds.
Effective CAPA programs are built on the ability to trend deviations, Ditch notes. Her rule of thumb: “If something occurs three times in a given period of time, it’s a trend.”
For example, if a trial is missing a lab value three or more times, it’s probably worth asking why, Ditch says. It’s easy to point the finger at a coordinator who seemingly failed to include a lab result, but a good CAPA might uncover other factors. Even a seemingly small issue like that can yield interesting results. “Keep asking why,” Ditch urges.
In that missing lab example, Ditch says it could be a core communication issue, something that is unclear in the protocol, or inadequate coordinator training. “It might [even be that] there is some sponsor accountability” for the problem, she notes.
Author: Michael Causey
