Preferred Label : Experimental Unit Unplanned Treatment Indicator;
NCIt related terms : ExperimentalUnit.unplannedTreatmentIndicator;
Alternative definition : BRIDG 5.3: Specifies whether the treatment plan actually received by the experimental
unit, as determined retrospectively, was not only NOT what was assigned, but was not
even defined as a valid treatment plan. EXAMPLE(S): If an A/B cross-over study only
has arms A-B and B-A and a given experimental unit has a treatment that is effectively
A-A, then unplannedTreatmentIndicator true. In SDTM, if DM.ACTARM Unplanned Treatment
or DM.ACTARMCD UNPLAN, then unplannedTreatmentIndicator true. OTHER NAME(S): NOTE(S):
If the treatment plan received by an experimental unit actually is a valid treatment
plan, whether or not it was what was assigned in the experimental unit allocation
activity, this is represented as an association from the ExperimentalUnit to the Arm,
with unplannedTreatmentIndicator false. Note that this attribute has a retrospective
nature - i.e. you might not know what treatment an experimental unit was actually
on until after all treatments have been completed and the blind, if any, has been
broken. This is typically the case for studies in which there may be more than one
randomization.;
NCI Metathesaurus CUI : CL977941;
Origin ID : C164805;
UMLS CUI : C5236600;
Semantic type(s)
- concept_is_in_subset
