Glossaries
Glossaries
| Term | Definition |
|---|---|
| system |
People, machines, software, applications, and/or methods organized to accomplish a set of specific functions or objectives. [ANSI]
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| synthetic data |
Data that are artificially created rather than being generated by actual events. NOTE: Data are often created with the help of algorithms and used for a wide range of activities, including as test data for new products and tools, for model validation, and in AI optimization. [After The Ultimate Guide to Synthetic Data in 2020, August 29, 2020]. See also artificial intelligence.
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| syntactic |
The order, format, content of clinical trial data and/or documents as distinct from their meaning. NOTE: Syntactic interoperability is achieved when information is correctly exchanged between two systems according to structured rules whether or not sensible meaning is preserved. See also semantic, semantic interoperability.
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| synopsis |
Brief overview prepared at the conclusion of a study as a routine part of a regulatory submission, summarizing the study plan and results; includes numerical summary of efficacy and safety results, study objective, criteria for inclusion, methodology, etc. [after ICH E3]
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| symptom |
An experience reported by a patient that may indicate a disease. NOTE: Some examples of symptoms are pain, fatigue, nausea, and anxiety. [After NCI Glossary] See also diagnosis, sign.
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| suspension (of a clinical trial) |
An interruption of the conduct of a clinical trial by a Member State of the EU. NOTE: Similar to FDA "clinical hold". [After EU CTR] See also clinical hold (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).
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| survey |
Any means (e.g., questionnaire, diary, interview script, group of items) that is used to collect PRO data. NOTE: survey refers to the content of the group of items and does not necessarily include the training and scoring documents generally not seen by respondents. [from ISOQOL comments on PRO Guidance] Compare to instrument.
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| surrogate variable |
A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical. [ICH E9]
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| surrogate marker |
A measurement of a drug's biological activity that substitutes for a clinically meaningful endpoint. [After Russell Katz, Biomarkers and Surrogate Markers: An FDA Perspective, NeuroRx. 2004 Apr;1(2):189-95.]
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| surrogate endpoint |
An endpoint that is used in clinical trials as a substitute for a direct measure of how a patient feels, functions, or survives. A surrogate endpoint does not measure the clinical benefit of primary interest in and of itself, but rather is expected to predict that clinical benefit or harm based on epidemiologic, therapeutic, pathophysiologic, or other scientific evidence. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource]. See also endpoint.
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| supplier (system) |
An organization that enters into a contract with the acquirer for the supply of a system (such as a software product, or software service) under the terms of a contract. [ISO/IEC/IEEE 12207:1995 3.30]
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| superiority trial |
A trial with the primary objective of showing that the response to the investigational product is superior to a comparative agent (active or placebo control). [ICH E9]
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| submission model |
A set of data standards (including SDTM, ADaM, and define.xml) for representing data that are submitted to regulatory authorities to support product marketing applications. NOTE: CDISC submission data consist of: tabulations that represent the essential data collected about patients; analysis data structured to support analysis and interpretation; and metadata descriptions.
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| subject-reported outcome (SRO) |
An outcome reported directly by a subject in a clinical trial. [Patrick, D.l., 2003] See also patient-reported outcome (PRO).
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| subject trial contact |
Any activity, anticipated in the study protocol, involving a subject and pertaining to collection of data. See visit.
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