Glossary- Clinical Trials Terminology – T to Z

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Glossary- Clinical Trials Terminology – T to Z

T

trial site The location(s) where trial-related activities are actually conducted.

triple-blind study A study in which knowledge of the treatment is concealed from the people who organize and analyze the data of a study as well as from subjects and investigators.

Type 1 (or Type I) error Error made when a null hypothesis is rejected but is actually true. Also called false positive.

Type 2 (or Type II) error Error made when an alternative hypothesis is rejected when it is actually true. Also called false negative.


U

unequal randomization A technique used to allocate subjects into groups at a differential rate; for example, three
subjects may be assigned to a treatment group for every one assigned to the control group.

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).


V

validation of data Procedure carried out to ensure that the data contained in the final clinical trial report match original observations

vulnerable subjects Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the
expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or
impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads,
refugees, minors, and those incapable of giving consent.


W

washout period A period in a clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated

Warning Letter A written communication from FDA notifying an individual or firm that the agency considers one or more products, practices, processes, or other activities to be in violation of the Federal FD&C Act, or other acts, and that failure of the responsible party to take appropriate and prompt action to correct and prevent
any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice.


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