Quality by design (QbD)
In Good Clinical Practice & ethics
Quality by design means building quality into a trial while it is being planned, instead of trying to inspect it in afterwards. In practice it starts by identifying which data and processes are truly critical to participant safety and to the reliability of the results. Everything else gets proportionate — not maximum — effort.
Why it matters
It is the thinking behind risk-based monitoring and behind ICH E6(R3). It explains why a modern monitor does not check 100% of every field.
Related terms
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