Documentation, reporting, and root cause analysis
Document deviations with required elements, assess impact on safety and data integrity, conduct root cause analysis using 5-Whys methodology, and submit reports through required channels.
The deviation happened — now what?
You have identified a deviation. You have classified it. Now begins the work that transforms a recognized problem into a documented record that serves the participant, the data, and the quality system. This is where many sites falter — not because coordinators are careless, but because deviation documentation is often treated as a bureaucratic task rather than a quality tool.