Terms starting with L

Label

A label is the description of a medicine product/device that includes: the conditions for which/reasons why the medicine/device should be used, who should use it, adverse events, instructions for use, and safety information.



Last Update Posted

The last update posted is the most recent date on which changes to a clinical study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the clinical study's sponsor or investigator (the last update submitted date) and the last update posted date. (CTG)



Last Update Submitted

The last update submitted is the most recent date on which the clinical study sponsor or investigator submitted changes to a clinical study record to ClinicalTrials.gov. There is typically a delay of a few days between the last update submitted date and when the date changes are posted on ClinicalTrials.gov (the last update posted date). (CTG)



Last Update Submitted the Met Quality Control (QC) Criteria

The last update submitted the met quality control (QC) criteria is the most recent date on which the clinical study sponsor or investigator submitted changes to a clinical study record that are consistent with National Library of Medicine (NLM) QC review criteria. It is the responsibility of the sponsor or investigator to ensure that the clinical study record is consistent with the NLM QC review criteria. (CTG)



Last Verified

Last verified is the most recent date on which the clinical study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a clinical study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past two years, the clinical study's recruitment status is shown as unknown. (CTG)



Lay-patient Review

A lay-patient review is specifically designed so that those who do not have a medical or scientific background can easily understand all aspects of a clinical study (e.g., its design, execution, results, analysis, discussion, implications, etc.). The purpose of this is to make clinical studies more transparent to the lay public so that they might not only better understand clinical studies but also their significance and importance to medical research.



Lay-patient Summary

A lay-patient summary is specifically designed so that those who do not have a medical or scientific background can easily understand all aspects of a clinical study (e.g., its design, execution, results, analysis, discussion, implications, etc.). The purpose of this is to make clinical studies more transparent to the lay public so that they might not only better understand clinical studies but also their significance and importance to medical research.



Life-threatening Adverse Event

A life-threatening adverse event is any adverse medicine event that places the study participant (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). (CDISC)



Life-threatening Adverse Experience

A life-threatening adverse experience is any adverse medicine experience that places the study participant (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). (CDISC)



Longitudinal Study

A longitudinal study is an investigation in which data are collected from a number of subjects over a long period of time. (CDISC)