Glossaries
Glossaries
| Term | Definition |
|---|---|
| functions |
The manner in which a patient can perform successfully tasks and roles required for everyday living. A patient's ability to perform specified activities that are a meaningful (to the patient), part of typical (e.g., daily) life. [FDA Clinical Outcome Assessment (COA) Glossary]
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functioning |
| functional roles (in a study) |
The function or responsibility assumed by a person in the context of a clinical study. Examples include data manager, investigator. [HL7]
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| frozen |
Status of a database, file, or element that has been presumed to be in its final state pending "lock" and where further editing is prevented without "unfreezing." NOTE: Freezing and unfreezing are usually formalized in audit trails and differ from "locking" and "unlocking" only in the degree of approval required. See database lock.
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| frequentist methods |
Statistical methods, such as significance tests and confidence intervals, which can be interpreted in terms of the frequency of certain outcomes occurring in hypothetical repeated realizations of the same experimental situation. [ICH E9]
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| Form |
A collection of items and item groups for capturing and displaying clinical trial data.
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| Food and Drug Administration (FDA) |
The United States regulatory authority charged with, among other responsibilities, granting IND and NDA approvals.
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| follow-up (clinical study) |
A period in a clinical study during which information about the health status of an individual is obtained after study interventions have concluded. [CDISC SDTM Terminology] See also long term follow-up (clinical study).
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| first-in-humans study |
The first Phase 1 study in which the test product is administered to human beings.
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first-in-man study |
| first subject treated - identity |
The first subject who is so treated.
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first patient treated - identity |
| first subject treated - date, time |
The date and/or date and time when the first subject receives the test article or placebo in a clinical investigation.
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first patient treated - date, time |
| first subject screened - identity |
The first subject who is so screened.
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first patient screened - identity |
| first subject screened - date, time |
The date and/or date and time the first subject signs the informed consent form and is screened for potential enrollment or randomization into a study, but has not yet been determined to meet the inclusion/exclusion criteria for the trial.
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first patient screened - date, time |
| first subject in - identity (FSI - identity) |
The first subject enrolled. See also enrollment.
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first patient in - identity; FPI - identity |
| first subject in - date, time (FSI - date, time) |
The date and/or date and time the first subject is enrolled into a study. See also enrollment.
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first patient in - date, time; FPI - date, time |
| finding |
A meaningful interpretation of data or observations resulting from planned evaluations. Compare to conclusion, hypothesis. See also general observation class, intervention, event.
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