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- NCIT_C156636 IAO_0000115 "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." @default.
- NCIT_C156636 NCIT_NHC0 "C156636" @default.
- NCIT_C156636 NCIT_P106 "Research Activity" @default.
- NCIT_C156636 NCIT_P108 "Serious Breach" @default.
- NCIT_C156636 NCIT_P208 "CL935705" @default.
- NCIT_C156636 NCIT_P322 "CDISC-GLOSS" @default.
- NCIT_C156636 NCIT_P325 "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." @default.
- NCIT_C156636 normalizedInformationContent "100" @default.
- NCIT_C156636 referenceCount "1" @default.
- NCIT_C156636 hasExactSynonym "Serious Breach" @default.
- NCIT_C156636 hasExactSynonym "serious breach" @default.
- NCIT_C156636 inSubset NCIT_C61410 @default.
- NCIT_C156636 inSubset NCIT_C67497 @default.
- NCIT_C156636 type Class @default.
- NCIT_C156636 isDefinedBy ncit.owl @default.
- NCIT_C156636 label "Serious Breach" @default.
- NCIT_C156636 subClassOf NCIT_C156636 @default.
- NCIT_C156636 subClassOf NCIT_C20181 @default.
- NCIT_C156636 subClassOf NCIT_C25499 @default.
- NCIT_C156636 subClassOf NCIT_C50996 @default.
- NCIT_C156636 subClassOf NCIT_C74589 @default.
- NCIT_C156636 subClassOf NCIT_C74590 @default.