Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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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| subject monitoring |
Act of tracking, reporting, and review of a clinical trial subject's status and/ or performance of required activities per protocol. NOTE: Examples include monitoring compliance with treatment and scheduled tasks, tracking measures of symptoms, self reported feelings, and/or behaviors. Subject monitoring supports managing of patient safety and well being by site staff as defined in a protocol. Compare with medical device, medical monitoring.
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| subject identification code |
A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data. [ICH]
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| subject data event |
A subject visit or other encounter where subject data are collected, generated, or reviewed. [SDTM]
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| subject completion |
The case where a subject ceases active participation in a trial because the subject has, or is presumed to have followed all appropriate conditions of a protocol.
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| sub-investigator |
Any member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows). [After ICH E6] See also investigator, coordinating investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator.
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| study variable |
A term used in trial design to denote a variable to be captured on the CRF. See also variable.
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| study start date |
The date on which the protocol-defined study start criteria are met. NOTE: The US FDA defines the study start date for clinical studies as the earliest date of informed consent among any subject that enrolled in the study. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021] See study start. [US FDA, Providing Regulatory Submissions In Electronic Format - Standardized Study Data Guidance for Industry, June 2021]
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| study start |
The criteria for study start, as defined in the protocol, are met.
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