A randomized trial is “blind” if subjects and study personnel (investigators, nurses, companies) are not told which arm of the trial the patient is in. A clinical trial is “blind” if subjects and study personnel are unaware of whether they are in the experimental or control (placebo) arm of a study. Blinded [...]
The process through which one or more parties to a clinical trial are unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware of the treatment assignments. In a double-blinded study, both the subjects and the investigators are unaware of the treatment assignments. Also, in a [...]
Any technique that uses living organisms, or substances from organisms, biological systems, or processes to make or modify a product or process, to change plants or animals, or to develop micro-organisms for specific uses.
A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man.
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; and/or the initial time point in a clinical trial, just before subjects begin receiving the experimental treatment being tested.
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