Preferred Label : Performed Protocol Deviation;
NCIt related terms : PerformedProtocolDeviation;
NCIt definition : A completed assessment for variation from process or procedures defined in a study
protocol.;
Alternative definition : BRIDG 3.0.3: A variation from process or procedures defined in a study protocol. EXAMPLE(S):
Study subject not withdrawn as per protocol, excluded concomitant medication, treatment
deviation. NOTE(S): Deviations usually do not preclude the overall evaluability of
subject data for either efficacy or safety.; BRIDG 5.3: A designation of an event as a variation from process or procedures defined
in a study protocol. EXAMPLE(S): Study subject not withdrawn as per protocol, excluded
concomitant medication, treatment deviation. OTHER NAME(S): NOTE(S): Deviations usually
do not preclude the overall evaluability of subject data for either efficacy or safety.;
Origin ID : C93434;
UMLS CUI : C2985646;
Semantic type(s)
- concept_is_in_subset
