Industry Terms Glossary
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Well-being of Trial Subjects
The physical and mental integrity of the subjects participating in a clinical trial. [ICH E6]
Trial Site
The location(s) where trial-related activities are actually conducted. [ICH E6]
Treatment Emergent
An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state. [ICH E9]
Treatment Effect
An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of interest is a comparison (or contrast) of two or more treatments. [ICH E9]
Toxicity
An adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat. [U.S. National Library of Medicine]