Preferred Label : Study Agent Characteristic Modified Indicator;
NCIt related terms : StudyAgent.characteristicModifiedIndicator;
Alternative definition : BRIDG 5.3: Specifies whether the agent's characteristic have been modified from those
approved in the marketing authorization in a way that could affect its quality. EXAMPLE(S):
OTHER NAME(S): NOTE(S): Modification may include a change in pharmaceutical form (e.g.
over-encapsulation, colour, dilution, re-tabletting for blinding etc.) or removal
from the primary packaging and repacking (e.g. removal from a blister and putting
in a bottle).;
NCI Metathesaurus CUI : CL978331;
Origin ID : C165124;
UMLS CUI : C5236913;
Semantic type(s)
- concept_is_in_subset
