Preferred Label : Serious Breach;
NCIt definition : 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.;
Alternative definition : CDISC-GLOSS: 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. [Article 52 of Regulation (EU) 536/2014
and Guideline for the notification of serious breaches of Regulation (EU) No 536/2014
or the clinical trial protocol] See also privacy breach.;
NCI Metathesaurus CUI : CL935705;
Origin ID : C156636;
UMLS CUI : C4745324;
Semantic type(s)
- concept_is_in_subset
