Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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 |
| Janus study data repository |
The Janus is a data repository for subject-level clinical and nonclinical study data submitted to FDA as part of a regulatory submission. NOTE: Sometimes written as JANUS, the term is not an acronym. [FDA Study Data Standards]
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| Janus conceptual model |
A logical design for a data warehouse intended to integrate submission data, protocol descriptions, and analysis plans from clinical and animal studies into an FDA review environment that uses a set of validated, standards-based tools to allow reproducible cross-study, data mining, and retrospective comparative analysis. [FDA Study Data Standards]
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| item group definition |
The specification in an eClinical trial of a collection of items often clinically related to each other and useful to consider as an ensemble. NOTE: Item groups are likely to have greater granularity in analysis datasets using SDTM which can, for example, distinguish between different therapy types: study therapy, prior therapy, concomitant therapy, protocol forbidden therapies, rescue therapies. [ODM]
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| item generation |
Establishing the content to be covered by the items in a PRO instrument, including generating item wording, evaluating the completeness of item coverage of the concepts of interest, and performing initial assessment of clarity and readability. NOTE: PRO instrument item generation is potentially incomplete without patient involvement. [from ISOQOL comments on PRO Draft Guidance]
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| item definition |
Formal specification of the properties of an item or field of data in an eClinical trial. [CDISC ODM, CDISC CDASH]
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