Preferred Label : Protocol Violation;
Alternative definition : CDISC: A significant departure from processes or procedures that were required by
the protocol. Violations often result in data that are not deemed evaluable for a
per-protocol analysis, and may require that the subject(s) who violate the protocol
be discontinued from the study. Compare to protocol deviation. (CDISC Glossary); CDISC-GLOSS: A significant departure from processes or procedures that were required
by the protocol. Violations often result in data that are not deemed evaluable for
a per-protocol analysis, and may require that the subject(s) who violate the protocol
be discontinued from the study. Compare to protocol deviation.;
NCI Metathesaurus CUI : CL540259;
Origin ID : C142185;
UMLS CUI : C1709750;
Semantic type(s)
- concept_is_in_subset
