Glossaries
Glossaries
| Term | Definition |
|---|---|
| uniform resource locator (URL) |
Address of a web page, for example, appliedclinicaltrialsonline.com.
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| unexpected serious risk |
A serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically or pathophysiologically related to an adverse drug experience identified in the labeling, but differs because of greater severity, specificity, or prevalence. [505-1(b) of FD&C Act (21 USC. 355-1(b)]
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| unexpected adverse drug reaction |
An adverse drug reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information (e.g., IB for an unapproved investigational product or PI/summary of product characteristics for an approved product, and/or scientific literature). [After ICH E6 (R2)]
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| unblinding |
Identification of the treatment code of a subject or grouped results in studies where the treatment assignment is unknown to the subject and investigators. [After EUPATI Toolbox: Within-trial decisions: Unblinding and termination. 2023]
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| umbrella trial design |
A type of trial design under a master protocol designed to evaluate multiple investigational drugs administered as single drugs or as drug combinations in a single disease population. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022]. See also master protocol.
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| type of comparison |
How treatment arms will be compared (e.g., safety, efficacy, PK/PD). May also include comparison to data from other studies or sources (e.g., historical control). [ICH E9, EudraCT (p.18)]
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| type 3 (or type III) error |
Some statisticians use this designation for an error made when calling the less effective treatment the more effective treatment.
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| type 2 (or type II) error |
Error made when an alternative hypothesis is rejected when it is actually true.
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false negative |
| type 1 (or type I) error |
Error made when a null hypothesis is rejected but is actually true.
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false positive |
| trustworthy (electronic records) |
An attribute of records (data and documents) and signatures submitted to regulatory agencies referring to their suitability for making scientific findings of safety and efficacy that underlie public policy decisions pertaining to market authorization. Two key dimensions that determine the trustworthiness of eClinical trial data are data quality and data integrity. [after 21CFR Part 11]
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| triple-blind study |
A study in which knowledge of the treatment assignment(s) is concealed from the people who organize and analyze the data of a study as well as from subjects and investigators.
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| trial statistician |
A statistician who has a combination of education/ training and experience sufficient to implement the principles in the ICH E9 guidance and who is responsible for the statistical aspects of the trial. [ICH E9]
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| trial site |
The location at which clinical trial activities are conducted. NOTE: Synonym for investigative site, investigator site, site, site of the trial, study site. [ICH E6 (R2)]
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| Trial Design Model |
Defines a standard structure for representing the planned sequence of events and the treatment plan of a trial. NOTE: A component of the SDTM that builds upon elements, arms epochs, visits; suitable also for syntactic interpretation by machines. [CDISC] See study design.
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| trial design element |
A basic building block for time within a clinical trial comprising the following characteristics: a description of what happens to the subject during the element; a definition of the start of the element; a rule for ending the element.[CDISC PRM Project] See also epoch.
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