Glossaries
Glossaries
| Term | Definition |
|---|---|
| medical monitoring |
Act of tracking the progress or severity of a disease, injury or handicap in patients in order to support a medical purpose. See also monitoring.
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| medical monitor |
A sponsor representative who has medical authority for the evaluation of the safety aspects of a clinical trial.
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| medical device |
Any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more specific medical purpose(s). NOTE: Specific medical purposes include diagnosis; prevention; monitoring; treatment or alleviation of disease; diagnosis; monitoring; treatment; alleviation of or compensation for an injury; investigation; replacement; modification; or support of the anatomy or of a physiological process; supporting or sustaining life, control of conception; disinfection of medical devices providing information by means of in vitro examination of specimens derived from the human body; and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means. [After REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices; After MHRA Guidance: Medical device stand-alone software including apps]
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| medical countermeasure |
Pharmaceutical products, such as vaccines, antimicrobials, and antitoxins, and nonpharmaceutical products, such as ventilators, diagnostic tests, personal protective equipment (PPE), and patient (also general) decontamination materials, that may be used to prevent, mitigate, or treat the adverse health effects from a public health emergency. [After National Health Security Strategy 2019-2022]
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| median |
The middle value in a data set; that is, just as many values are greater than the median and lower than the median value. (With an even number of values, the conventional median is halfway between the two middle values.)
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| MedDRA (Medical Dictionary for Regulatory Activities) |
A global standard medical terminology designed to supersede other terminologies used in the medical product development process, including COSTART, ICD9, and others.
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| mean |
The sum of the values of all observations or data points divided by the number of observations; an arithmetical average.
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| matched-pair design |
A type of parallel trial design in which investigators identify pairs of subjects who are 'identical' with respect to relevant factors, then randomize them so that one receives Treatment a and the other Treatment B. See also pairing.
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| master protocol |
A protocol designed to enable multiple substudies, which may have different objectives and involve coordinated efforts to evaluate one or more investigational drugs in one or more disease subtypes within the overall trial structure. NOTE: The term "master protocol" is often used to describe the design of such trials, with terms such as "umbrella", "basket", or "platform" describing specific designs. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022] See also umbrella trial design, basket trial design, platform trial design, adaptive design.
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| masking |
The mechanism used to obscure the distinctive characteristics of the study intervention or procedure to make it indistinguishable from the comparator. NOTE: Blinding refers to study participants while masking refers to the study intervention. [After Crisp A. Blinding in pharmaceutical clinical trials: An overview of points to consider. Contemp Clin Trials. 2015;43:155-163.] See also blinding.
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| markup |
Computer-processable annotations within a multimedia document. NOTE: in the context of the HL7 specification, markup syntax is according to the XML specification. [HL7]
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| marketing support trials |
Clinical studies that are designed to clarify therapeutic benefits of a marketed product or to show potential decision-makers the rationale for preferring one therapy over another.
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| marketing authorization procedure |
Formal EU procedure applied by a medicines regulatory agency to grant a marketing authorization, to amend an existing one, to extend its duration or to revoke it. [After ISO 11615:2017, 3.1.43]
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| marketing authorization holder |
Organization or person that is permitted to market a medicinal product in a jurisdiction. [After ISO 11615:2017, 3.1.41]
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| marketing authorization |
Authorisation issued from a medicines regulatory agency that allows a Medicinal Product to be placed on the market. [after ISO 11615 2017-10 on Regulated Medicinal Product information]
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marketing approval |
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