Glossaries
Glossaries
| Term | Definition |
|---|---|
| low-interventional clinical trial |
A clinical trial which fulfills all of the following conditions: (a) the investigational medicinal products, excluding placebos, are authorized; (b) according to the protocol of the clinical trial, (i) the investigational medicinal products are used in accordance with the terms of the marketing authorization; or (ii) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and (c) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned. [REGULATION (EU) No 536/2014 Article 2.2.(3)]
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| longitudinal study |
Investigation in which data are collected from a number of subjects over a long period of time (a well-known example is the Framingham study).
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| long term follow-up (clinical study) |
Planned observations that are made over an extended period of time and are a formal phase of a clinical study. NOTE: LTFU may be a post-study commitment. [After Long Term Follow-up After Administration of Human Gene Therapy Products. FDA Guidance for Industry. JAN 2020] See also follow-up (clinical study).
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LTFU |
| life-threatening adverse event/ experience |
Any adverse drug experience that places the patient or subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred (i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death). [FDA 21 CFR 312.32; ICH-E2A]
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| legally acceptable representative |
An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial. [ICH, E6 Glossary]
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| legal authentication |
A completion status in which a document has been signed manually or electronically by the individual who is legally responsible for that document. [HL7]
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| last subject last visit - identity (LSLV - identity) |
The last subject to reach a planned or achieved milestone representing the completion of the trial.
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last subject complete - identity; last subject out - identity; LPC-dentity; LPO - identity; LSC - identity; LSO - identity |
| last subject last visit - date, time (LSLV - date, time) |
The date and/or date and time when a last subject has reached a planned or achieved milestone representing the completion of the trial.
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last subject out/complete (LSC/LPC or LSO/LPO) - date, time) |
| last subject in - identity (LSI - identity) |
The last subject enrolled in a clinical trial.
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last patient in - identity; LPI - identity |
| last subject in - date, time (LSI - date, time) |
The date and/or date and time when a last subject to participate in a clinical trial is enrolled.
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last patient in - date, time; LPI - date, time |
| laboratory (clinical) |
A laboratory providing analyses of samples collected in clinical care or research.
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| labeling (content of) |
All text, tables, and figures in labeling as described in regulations for a specific product (e.g., 21 CFR 201.56 and 201.57 for human prescription drugs; 201.66 for human over-the-counter drugs; 21 CFR 801 for medical devices; and 21 CFR 606.122 for blood products). See also structured product label.
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| label |
Description of a drug product/ device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities. [FDA; SPL]
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package insert, patient package leaflet |
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