Preferred Label : FDA Clinical Outcome Assessment Qualification;
NCIt synonyms : COA Qualification;
NCIt related terms : clinical outcome assessment (COA) qualification;
NCIt definition : FDA confirmation that a clinical outcome assessment is a reliable measure for a specific
interpretation and application within the stated context of use.;
Alternative definition : CDISC-GLOSS: A formal conclusion by FDA that, within the stated context of use, the
results of the COA measurement can be relied upon to have a specific interpretation
and application. NOTE: For qualified COAs, FDA permits drug developers to use the
COA in the qualified context in IND and NDA/BLA submissions without requesting that
the relevant CDER review group reconsider and reconfirm the suitability of the COA.
[FDA Clinical Outcome Assessment (COA) Glossary];
NCI Metathesaurus CUI : CL540483;
Origin ID : C142552;
UMLS CUI : C4684667;
Semantic type(s)
- concept_is_in_subset
