Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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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| monitoring plan |
A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial. [ICH E6(R2) Glossary Addendum] See also monitoring.
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| monitoring |
Act of overseeing, tracking, observing, evaluating or supervising over time by a person, device or system. See also subject monitoring, medical monitoring, study monitoring, trial monitoring, data monitoring, risk based monitoring.
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| monitor |
Person employed by the sponsor or CRO who is responsible for determining that a trial is being conducted in accordance with the protocol and GCP guidance. NOTE: A monitor's duties may include, but are not limited to, helping to plan and initiate a trial, assessing the conduct of trials, and assisting in data analysis, interpretation, and extrapolation. Monitors work with the clinical research coordinator to check all data and documentation from the trial. [from ICH E6, 5.18] See also clinical research associate.
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| moiety |
An entity that has a complete and continuous molecular structure and is part of a substance. The active moiety of the molecule is the basis for the physiological or pharmacological action of the drug substance. NOTE: The strength of a pharmaceutical product is often based on what is referred to as the active moiety. [after ISO 11238 2012-11 on Regulated information on Substances]
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| modem |
From modulator/ demodulator; a device that converts digital data into analog data that can be transmitted via telephone or cable lines used for communications.
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| model |
A formal structure for representing and analyzing a process such as a clinical trial or the information pertaining to a restricted context (e.g., clinical trial data). [CDISC]
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| mode |
The most frequently occurring value in a data set.
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| missing data |
Data not completed or corrupted in reports and case report forms, e.g., the data not captured when a subject withdraws from a trial. NOTE: Reviewers are concerned about missing data since patients who are not improved or who believe they have experienced side effects may be particularly prone to leave a trial, thus skewing the analysis of results if such analysis were to be done only on the subjects who had continued with the trial. Trial designs therefore specify plans for how such missing data will be treated in analysis. See also intention to treat. [FDA Guidance on Subject Withdrawal, 2008]
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