Reducing Protocol Deviations With Training-Based Metrics

By Beth Harper, Chief Learning Officer at Pro-ficiency

Protocol deviations can have a detrimental effect on new drug development, adding to costs and time to clinical trials and even putting the acceptability of data generated during a study at risk. Despite this, protocol deviations seem to be viewed as just part of doing business in the clinical research arena. And one question that arises is whether training in individual protocols is adequate, given the frequency with which deviations occur.

In its recent analysis of inspectional findings during 2021, the FDA said in its annual BIMO metrics report that protocol deviations or failure to follow the investigational plan was the most common observation listed on Form 483s after a BIMO inspection. This was also the most-frequent Form 483 observation during 2020, and has been at the top of the list for the last several years, the FDA noted.