Page 36 - Terminology-Clinical-Research

Multiple Member States: This is where the trial will be unique identification code is given to each clinical study
conducted in more than one Member State of the European registered on ClinicalTrials.gov. Because the format is
Economic Area. “NCT” followed by an 8-digit number (for example,
NCT00000419).
Multiple sites in the Member State concerned: A trial is
conducted in multiple sites in the concerned Member State. NDA: See New Drug Application.

Multiple-rising dose study: See dose-ranging study. New Drug Application (NDA): An application submitted
by a sponsor to the FDA for approval to market a new drug
Multivariate analysis: Measuring the impact of more than (a new, non-biological molecular entity) for human use in
one variable at a time while analyzing a set of data, such interstate commerce in the United States.
as looking at the impact of age, sex, and occupation on a
particular outcome. Performed using regression analysis. New safety information: With respect to a drug,
information derived from a clinical trial, an adverse
event report, a post-approval study, or peer-reviewed
biomedical literature; data derived from the post market
N risk identification and analysis system (REMS); or other
scientific data regarding: (a) 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
Name of organisation: Name of individual, company, assessed (b) the effectiveness of the approved REMS for
institution or organisation which takes responsibility for the the drug obtained since the last assessment of such strategy.
initiation, management and/or financing of the clinical trial.
Newborns: Subjects are newborn babies from birth to less
Name or abbreviated title of the trial: A shortened title or than 28 days of age.
description of the clinical trial.
NIH: See National Institutes of Health.
National Competent Authority (NCA): See Competent
Authority. No intervention arm: A group of participants that does not
receive any interventions during a clinical study. One of
National Institutes of Health (NIH): Agency within the several arm types.
Department of Health and Human Services that funds N-of-1 study: A trial in which an individual subject is
research, conducts studies, and funds multicenter national
studies. administered a treatment repeatedly over a number of
episodes to establish the treatment’s effect in that person,
National Medicine Regulatory Authorities: See often with the order of experimental and control treatments
Competent Authority. randomized.

Natural history study: Study of the natural development Nomenclature: Application of naming conventions.
of something (such as an organism or a disease) over a
period of time. Nonclinical study: Biomedical studies not performed on
human subjects.
Natural language: Language as used in ordinary
communications among humans and distinguished from Noninferiority trial: A trial designed to determine whether
controlled terminologies and structured languages used the effect of a new treatment is not worse than a standard
treatment by more than a pre-specified amount. A one-sided
exclusively for communication and interoperability among
machines. version of an equivalence trial.
Non-interventional study: A study where the medicinal
NCI Enterprise Vocabulary Services (EVS): Provides
resources and services to meet NCI needs for controlled product(s) is (are) prescribed in the usual manner in
terminology, and to facilitate the standardization of accordance with the terms of the marketing authorization.
The assignment of the patient to a particular therapeutic
terminology and information systems across the Institute
and the larger biomedical community. strategy is not decided in advance by a trial protocol
but falls within current practice and the prescription of
NCT number (or ClinicalTrials.gov Identifier): A the medicine is clearly separated from the decision to

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