Apply Five Whys to identify a process-level cause for a protocol deviation.
Week 8 visit occurred three days outside the protocol window. Five Whys: move from symptom to controllable process cause, then use Five Hows to design prevention Stopping at "participant forgot" creates blame and leaves the site's scheduling system unchanged. Why 1 Why was the visit late? The participant missed the original appointment. This is the event, not yet a root cause. Why 2 Why did they miss it? The reminder call said Tuesday was preferred but did not mention it was the last in-window day. Now the process starts to appear. Why 3 Why did the reminder omit the window?…
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