An Effective Corrective and Preventive Action Plan (CAPA) for practitioners in clinical trials focuses like a laser on the root cause of a protocol deviation by adamantly asking, “Why did something happen,” said Mindy Ditch, MS, president and founder of Bloom Clinical Research, LLC. Unfortunately, when given the challenge, some people are “intimidated” into trying to develop a workable CAPA program, she adds.
Part of the problem comes from the overcomplication of the problem, says Ditch, who will present a session on all topics related to CAPA in the September segment of the ACRP 2021 virtual conference. “It’s time to demystify CAPA and the CAPA process,” she advises. “Say it in simple terms and make it less intimidating.”
It starts with giving up the acronym “CAPA” for a moment and taking a step back to see what it stands for. “CAPA is about understanding why something happened and preventing it from happening again,” she says. It literally focuses on corrective and preventive action in response to cases of non-compliance with study protocols rather than a more nebulous and complicated task, she adds.
Implementation of a CAPA system for the management of protocol deviations
Visit Ditch on Thursday, September 30th, during the third and final tranche of ACRP 2021 for even more insight into solutions to implement a CAPA strategy specifically geared towards protocol discrepancy management.
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Effective CAPA programs are based on the ability to spot anomalies, notes Ditch. Your rule of thumb: “If something happens three times in a certain period of time, it’s a trend.”
For example, if a study is missing a lab reading three or more times, it’s probably worth asking why, Ditch says. It’s easy to point a finger at a coordinator who doesn’t seem to have taken a lab result, but a good CAPA can reveal other factors. Even a seemingly minor problem like this can produce interesting results. “Keep asking why,” Ditch urges.
That missing lab example, Ditch says, could be a key communication problem, something unclear in the log, or inadequate coordinator training. “It could [even be that] there is some sponsor responsibility for the problem, she notes.
Author: Michael Causey