Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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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| study report completion date |
The date at which the study report is considered final and will not be subject to any further change prior to submission. NOTE: For interventional studies of adults the study report completion date should be one year from the end of the LPLV, or end of study; for pediatric interventional studies this date should be six months. For non-interventional studies the study report completion date should be one year from the end of the LPLV, end of study, or end of data collection. [EU CTR]
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| study publication date |
The date of the publication of scientific articles or abstracts about a clinical study. NOTE: Institute of Medicine (IOM) Report: The committee noted support for open and free access to scientific publications immediately upon publication, as well as the requirement of the U.S. Food and Drug Administration (FDA) to make a summary of clinical trial results available to the public. [ClinicalTrials.gov]
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| study population |
A group of individuals taken from the general population who share a set of common characteristics, such as age, sex, or health condition, precisely defined in the study protocol. This is a population to which the study results could be reasonably generalized. (CDISC Protocol Entities)
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| study participant |
A member of the clinical study population from whom data are being collected. NOTE: This new term is used with growing frequency in some clinical documents and patient-facing ones like the informed consent form, Plain Language Summaries of study results, and publications. Subject or patient are terms used in regulatory guidelines, databases, other clinical research documents, or systems to refer to study participants. See also human subject, patient, vulnerable subjects, data subject, clinical research subject, participant.
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| study monitoring |
The act of overseeing the progress of a clinical study to ensure that it is conducted (and that events are recorded and reported) in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [After ICH E6 Glossary] See also monitoring, subject monitoring, medical monitoring, study monitoring, data monitoring, risk based monitoring.
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Trial Monitoring |
| study design schematic |
A diagram that outlines the decision points (e.g. randomization, response evaluation) that define the different paths a participant could take through the study. This is typically a block diagram and may include epochs, timing of randomization, treatment arms, and duration of treatments. [CDISC Terminology; After ICH E3]
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| study design rationale |
Reason(s) for choosing the study design. NOTE: Reasons may include the choice of control, comparator or population, as well as the scientific or statistical rationale.
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