Industry Terms Glossary

B

Baseline

Information gathered at the beginning of a study from which variations found in the study are measured; a known value or quantity with which an unknown is compared when measured or assessed; the initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values. [U.S. National Library of Medicine]

Bias

The systematic tendency of any factors associated with the design, conduct, analysis and evaluation of the results of a clinical trial to make the estimate of a treatment effect deviate from its true value. Bias introduced through deviations in conduct is referred to as 'operational' bias. The other sources of bias listed above are referred to as 'statistical'. [ICH E9]

Biometrics

A method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. [From 21CFR11]

Biometrics

A group or department that uses statistical analysis and accompanying techniques to study, interpret, and explain data in the biological sciences. Possible roles within this group are statisticians, statistical programmers, and medical writers.

Blinding/masking

A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s). [From ICH E6]