Serious breach

In Oversight, quality & inspection

A serious breach is a departure from the protocol or from GCP that is likely to significantly affect participant safety or physical or mental integrity, or the reliability of the trial's results. In several regions, including the EU and the UK, sponsors must report serious breaches to the authority within a short fixed period. It is a much higher bar than an ordinary protocol deviation.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.