Glossary of Clinical Research - U

U

• Uncontrolled study

A clinical study that lacks a comparison (i.e., a control) group. (NCI)

• Unexpected Adverse Drug Reaction

An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). (ICH E6)