Preferred Label : Protocol Deviation;
NCIt synonyms : Deviation;
NCIt related terms : DVTERM;
NCIt definition : A variation from processes or procedures defined in a protocol. Deviations usually
do not preclude the overall evaluability of subject data for either efficacy or safety,
and are often acknowledged and accepted in advance by the sponsor. (CDISC Glossary);
Alternative definition : CDISC: A variation from processes or procedures defined in a protocol. Deviations
usually do not preclude the overall evaluability of subject data for either efficacy
or safety, and are often acknowledged and accepted in advance by the sponsor. NOTE:
Good clinical practice recommends that deviations be summarized by site and by category
as part of the report of study results so that the possible importance of the deviations
to the findings of the study can be assessed. Compare to protocol violation. [See
ICH E3] (CDISC Glossary); CDISC-GLOSS: A variation from processes or procedures defined in a protocol. Deviations
usually do not preclude the overall evaluability of subject data for either efficacy
or safety, and are often acknowledged and accepted in advance by the sponsor. NOTE:
Good clinical practice recommends that deviations be summarized by site and by category
as part of the report of study results so that the possible importance of the deviations
to the findings of the study can be assessed. Compare to protocol violation. [See
ICH E3];
Origin ID : C50996;
UMLS CUI : C1705236; C1709750;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
