Analyzing Protocol Deviations Before Retraining

By Beth Harper, Chief Learning Officer

Major issues can arise during clinical trials when there is a protocol deviation, often delaying a study’s completion because sites and sponsors must investigate and address them. If not handled correctly, protocol deviations are likely to reoccur, costing studies more time and money.

What does it require to effectively address a deviation? The research sector seems prone to skipping a thorough root cause analysis, which is a necessary component of any corrective and preventative action (CAPA) plan directed at a deviation. Instead, the common response is to throw more training at the problem in the interest of checking a box on a form and moving forward quickly.

Instead of simply retraining site personnel to operate on autopilot, however, sponsors and sites would benefit more if they paused when a deviation occurs to conduct a root cause analysis to determine the actual cause of the issue, and then specifically tailor a CAPA response to that issue or set of issues.

Determine what constitutes addressing protocol deviations properly and how to create a CAPA plan to avoid trial setbacks.