Finding
serious breach
se·ri·ous breach
Definitions related to serious breach:
  • A breach of Clinical Trial Regulation (EU) No 536/2014 or of the version of the protocol applicable at the time of the breach, which is likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.
    CDISC Terminology
    Clinical Data Interchange Standards Consortium (CDISC), 2021
  • A deviation from clinical trial protocol that is likely to affect, to a significant degree, the safety, physical, or mental integrity of the subjects of the trial, or the scientific value of the trial.
    NCI
    U.S. National Cancer Institute, 2021
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