Many people in our industry have had root cause analysis (RCA) training. It is aimed at helping people understand an issue and the underlying reasons it happened. Once you have those reasons (the “root causes”), you can act on them. This is the most effective way of trying to stop the same issue from recurring. And RCA is now a requirement for serious issues per ICH E6 (R2).

As someone who obsesses about root cause analyses, I have naturally been thinking about the primary root causes for why we seem to have lost focus and interest in the sites and what we can do about it.