Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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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| minor |
A subject who, according to the law of the applicable jurisdiction concerned, is under the age of legal competence to give informed consent. [after EU CTR]
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| migration |
The act of moving a system or software product (including data) from an old to new operational environment in accordance with a software quality system. ISO/IEC/IEEE 12207:1995 5.5.5]
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| metadata |
Data that describe other data, particularly XML tags characterizing attributes of values in clinical data fields.
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| metabolism |
The biochemical alteration of substances introduced into the body.
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| meta-analysis protocol |
The document describing the plan for combining of evidence from relevant studies using appropriate statistical methods to allow inference to be made to the population of interest. NOTE: The most common reason for performing a meta-analysis is to provide an estimate of a treatment effect or measure of relative risk associated with an intervention and to quantify the uncertainty about the estimated effect or risk, when data from a single existing study are insufficient for this purpose. [FDA Draft Guidance, Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry, November 2018] See also meta-analysis.
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| meta-analysis |
The formal evaluation of the quantitative evidence from two or more trials bearing on the same question. NOTE: This most commonly involves the statistical combination of summary statistics from the various trials, but the term is sometimes also used to refer to the combination of the raw data. The methodology for performing the meta-analysis can be found in a meta-analysis protocol, or plan. [After ICH E9 Glossary] See also meta-analysis protocol.
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| message (HL7) |
The atomic unit of data transferred between systems. It comprises a group of segments in a defined sequence, each message has a message type that defines its purpose. NOTE: For example, the Admission, Discharge and Transfer (ADT) Message type is used to transmit portions of a patient's ADT data from one system to another. in HL7, a three-character code contained within each message identifies its type. [HL7]
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