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Qdossier Qsauri
"C"

context of use, clinical outcome assessment
Guideline or reference source
FDACOA Clinical outcome assessment glossary
Definition
A comprehensive statement that fully and clearly describes the way the COA is to be used and the drug development-related purpose of the use. The COU defines the boundaries within which the available data adequately justify use of the COA and describes important criteria regarding the circumstances under which the COA is qualified.
Abbreviation for
COU
Related Term
clinical outcome assessment
 

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