Glossaries
Glossaries
| Term | Definition |
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| treatment-emergent adverse event |
An event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state. [ICH E9]
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| treatment benefit |
The impact of treatment as measured by survival or a COA of how patients feel or function. Direct evidence of treatment benefit is derived from clinical trial effectiveness endpoints that measure survival or a meaningful aspect of how a patient feels or functions in daily life. NOTE: Treatment benefit can be demonstrated by an advantage in either effectiveness or safety, or both. [After FDA Clinical Outcome Assessment (COA) Glossary]
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| treatment |
Medical care given to a patient to mitigate or cure an illness, injury, or reduced health status. NOTE: May include prescribed drugs, biologics, surgery, devices, and physical or psychotherapies, but not diagnostics or prophylaxis. See also intervention, diagnosis.
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therapy |
| transmit |
To transfer data, usually electronically. NOTE: In eClinical investigations data are commonly transmitted from subjects to clinical study sites, within or among clinical study sites, contract research organizations, data management centers, and sponsors, or to regulatory authorities. [modified from CSUICI].
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| translational research |
The multidirectional integration of basic research, patient-oriented research, and population-based research, with the long-term aim of improving the health of the public. NOTE: These studies are designed to translate basic science findings into clinically useful tools and applications and to ensure that new treatments and research knowledge reach the patients or populations for whom they are intended and are implemented correctly. [After Rubio DM, Schoenbaum EE, Lee LS, Schteingart DE, Marantz PR, Anderson KE, Platt LD, Baez A, Esposito K. Defining translational research: implications for training. Acad Med. 2010 Mar;85(3):470-5. and NCI Thesaurus]
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| 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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