Glossaries
Glossaries
| Term | Definition |
|---|---|
| nomenclature |
Application of naming conventions. Compare to vocabulary, terminology.
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| NOEL (no observable effect level) |
The dose of an experimental drug given preclinically that does not produce an observable toxicity.
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| new safety information |
Previously unknown safety information derived from: (A) a clinical trial, an adverse event report, a post-approval study, or peer-reviewed biomedical literature; (B) the post-market risk identification and analysis system (REMS); or, (C) other scientific data regarding, (i) a serious risk or unexpected serious risk associated with use of the drug since the drug was approved, since the REMS was required or last assessed, or (ii) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy. [After 21 CFR, Part 505-1(b)]
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| New Drug Application (NDA) |
An application to FDA for a license to market a new drug in the United States.
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| NCI Enterprise Vocabulary Services (EVS) |
A US national resource to house and maintain a number of health-related glossaries and controlled vocabularies under strict versioning. Provides resources and services to meet the National Cancer Institute's needs for controlled terminology, and to facilitate the standardization of terminology and information systems across the NCI and the larger biomedical community.
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| natural language processing |
The use of algorithms to determine properties of natural, human language so that computers can understand what humans have written or said. NLP includes teaching computer systems how to extract data from bodies of written text, translate from one language to another, and recognize printed or handwritten words. NOTE: NLP is the field that allows for our everyday use of virtual assistants such as Siri, Alexa, or Google. [After DeepAI Definitions] See also artificial intelligence (AI).
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| natural language |
Language as used in ordinary communications among humans and distinguished from controlled terminologies and structured languages used exclusively for communication and interoperability among machines.
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| n-of-1 study |
A trial in which an individual subject is administered a treatment repeatedly over a number of episodes to establish the treatment's effect in that person, often with the order of experimental and control treatments randomized.
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| mutual recognition procedure (MRP) |
The EU procedure to be used when a product is already authorized in at least one Member State and the Marketing Authorization Holder wishes to obtain a Marketing Authorization (MA) for the same product in at least one other Member State. The Member State that has already authorized the product is known as the Reference Member State (RMS). The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member State/s (CMS). If the applicant is successful, the CMS will then issue a MA for that product permitting the marketing of that product in their country. [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem.html] See also Reference Member State (RMS) and Concerned Member State (CMS).
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| multicenter trial |
Clinical trial conducted according to a single protocol but at more than one site and, therefore, carried out by more than one investigator. [ICH E9 Glossary] See investigator/institution, study.
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| mortality rate |
A measure of the frequency of occurrence of death in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] See also morbidity, morbidity rate, incidence, prevalence, incidence rate.
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| morbidity rate |
A measure of the frequency of occurrence of a specific disease, injury, or disability in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] See also morbidity, incidence, prevalence, mortality rate, incidence rate.
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| morbidity |
Departure from physiological or psychological health, i.e., disease, injury, or disability. NOTE: Most often measures of morbidity frequency characterize the number of persons in a population who become ill (incidence) or are ill at a given time (prevalence). See also morbidity rate, incidence, prevalence, mortality rate, incidence rate, virulence.
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| monitoring visit |
A visit to a study site to review the progress of a clinical study and to ensure protocol adherence, accuracy of data, safety of subjects, and compliance with regulatory requirements and good clinical practice guidelines. [from ICH E6, 5.18]
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| monitoring report |
A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOPs. [ICH]
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