Glossaries
Glossaries
| Term | Definition |
|---|---|
| translation |
Converting information from one natural language to another while preserving meaning. Compare to mapping.
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| transition rule |
A guide that governs the allocation of subjects to operational options at a discrete decision point or branch (e.g., assignment to a particular arm, discontinuation) within a clinical trial plan. See branch.
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| transcription |
Process of transforming dictated or otherwise documented information from one storage medium to another. NOTE: often refers explicitly to data that is manually transcribed from source docs or measuring devices to CRFs or to eCRFs.
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| traceability (data) |
The ability to track data from source data collection through final use in reporting or analysis to ensure data interoperability, integrity, and interpretability. See also data integrity.
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| token |
Physical key that provides access to a secure electronic system or location.
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| therapeutic index |
The ratio of the dose that produces toxicity (denominator) to the dose that produces a clinically desired or effective response (numerator). NOTE: The therapeutic index is a measure of a drug's safety, because a larger value indicates a wide margin between doses that are effective and doses that are toxic. [After Finkel, R, Clark, M. A., Champe, P. C. & Cubeddu, L. X. (eds) Lippincott's Illustrated Reviews: Pharmacology 4th edn (Lippincott Williams & Wilkins, 2008).]
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| therapeutic area |
A category for a disease, disorder, or other condition based on common characteristics and often associated with a medical specialty focusing on research and development of specific therapeutic interventions for the purpose of treatment and prevention. (After NCI)
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| terminology |
Set of concepts, designations, and relationships for a specialized subject area. NOTE: In the context of clinical research in human subjects, a standardized, finite set of terms (e.g., CDISC Terminology, MedDRA codes) that denote patient findings, circumstances, events, and interventions. See also glossary, vocabulary. Contrast with nomenclature.
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| termination (of a clinical trial) |
Discontinuation of a trial prior to plan as defined in the protocol. NOTE: Additional information can be found in Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual: Premature Termination or Suspension of a Clinical Trial, 19 January 2021. See also discontinuation, suspension (of a clinical trial), clinical hold (of a clinical trial), temporary halt (of a clinical trial).
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| term |
One or more words designating something. NOTE: In a controlled vocabulary, terms are considered to refer to an underlying concept having a single meaning. Concepts may be linked to several synonymous terms.
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| temporary halt (of a clinical trial) |
An interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it. [After EU CTR] See also termination (of a clinical trial), clinical hold (of a clinical trial), suspension (of a clinical trial).
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| technology provider |
A person, company, or other entity who develops, produces, and sells software applications and/or hardware for use in conducting clinical trials and/or in analyzing clinical trial data and or submitting clinical trial information for regulatory approval.
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technology vendor |
| target population |
Population of patients to which the indication of a medicinal product applies. NOTE: The term applies to investigational and authorized medicinal products. [After ISO 11615.2012]
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| target enrollment |
The number of subjects in a cohort and in the entire study intended to be enrolled to reach the planned sample size. NOTE: Target enrollments are set by sample size calculations so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by algorithm or other specified process. [After ICH E9; After clinicaltrials.gov] See also sample size.
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| tabulation dataset |
A dataset structured in a tabular format. NOTE: The CDISC Study Data Tabulation Model (SDTM) defines standards for tabulation datasets that fulfill FDA requirements for submitting clinical trial data.
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