Glossaries
Glossaries
| Term | Definition |
|---|---|
| SEND (standard for the exchange of nonclinical data) |
The CDISC standard for the exchange of nonclinical data whose focus is on data collected from animal toxicology studies. [CDISC]
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| semantic interoperability |
The ability of data shared by systems to be understood at the level of fully defined domain concepts. [ISO 18308]
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| semantic |
In the context of a technical specification, semantic refers to the meaning of an element as distinct from its syntax. syntax can change without affecting semantics. [HL7]
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| self-evident change |
A data discrepancy that can be easily and obviously resolved on the basis of existing information on the CRF (e.g., obvious spelling errors or the patient is known to be a male and a date of last pregnancy is provided). See also discrepancy.
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| secondary sponsor |
Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. [WHO, CTR item 6]
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| secondary outcome variable |
Data on secondary outcomes are used to evaluate additional effects of the intervention. The primary outcome is the outcome of greatest importance. [after CONSORT statement] See also outcome, endpoint.
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| secondary objective |
Secondary objectives are supportive or ancillary questions of interest in a trial that will provide further information on the use of the treatment. See also primary objective, objective.
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| script |
A program or a sequence of instructions that are interpreted or carried out by another program or by a person.
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| screening trials |
A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Clinicaltrials.gov)
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| screening (period) |
A period in a clinical study during which subjects are evaluated for participation in the study. See also screening (of subjects)
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| screening (of subjects) |
A process of active evaluation for potential participation in a trial, including whether the protocol inclusion and exclusion criteria are met. [After FDA GLOSSARY OF TERMS ON CLINICAL TRIALS FOR PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING] See also screen failure.
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| screening (of sites) |
Determining the suitability of an investigative site and personnel to participate in a clinical trial.
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| screen/screening (of substances) |
Screening is the process by which substances are evaluated in a battery of tests or assays (screens) designed to detect a specific biological property or activity. It can be conducted on a random basis in which substances are tested without any preselection criteria or on a targeted basis in which information on a substance with known activity and structure is used as a basis for selecting other similar substances on which to run the battery of tests. [SQA]
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| screen failure |
At screening, when a potential subject does not meet study eligibility criteria. See also screening (of subjects). [After Segen's Medical Dictionary]
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| schedule of assessments |
A tabular representation of planned protocol events and activities, in sequence. [after E3 Annexes IIIa and IIIb] Compare to study design schematic.
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