Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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]
Hits - 55
|
| 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]
Hits - 48
|
| metadata |
Data that describe other data, particularly XML tags characterizing attributes of values in clinical data fields.
Hits - 42
|
| metabolism |
The biochemical alteration of substances introduced into the body.
Hits - 40
|
| 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 [FDA Draft Guidance, Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products Guidance for Industry, November 2018] See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.
Hits - 44
|
| 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.
Hits - 47
|
| 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]
Hits - 46
|
| memorandum of understanding (MOU) |
A formal agreement between the Food and Drug administration (FDA) and federal, state, or local government agencies; academic institutions; and other entities. NOTE: The MOU constitutes an understanding between the parties but is a non-binding agreement. it is FDA's policy to enter into MOUs with other entities whenever there is a need to define lines of authority or responsibility, or to clarify cooperative procedures.
Hits - 70
|
| mega-trials |
Massive trials that test the advantages of therapeutic interventions by enrolling 10,000 or more subjects.
Hits - 49 Synonyms -
large sample trial |
| Medicines and Healthcare products Regulatory agency (MHRA) |
The UK government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. [MHRA]
Hits - 68
|
| medicinal product name |
Name as authorized by a Medicines Regulatory Agency. NOTE: As a general principle, a marketing authorization is granted to a single Marketing Authorization Holder or sponsor who is responsible for placing a single Medicinal Product on the market. The marketing authorization contains the name of the Medicinal Product, which can refer to, for example, a single invented name or a scientific name [when available, the INN of the active substance(s)] accompanied by a trademark or other characteristics. Other characteristics of the name can refer to strength, pharmaceutical form, intended usage or an administration device, etc. [After ISO 11615:2017, 3.1.54] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name, compendial name.
Hits - 45
|
| medicinal product identifier |
Unique identifier allocated to a medicinal product supplementary to any existing authorization number as ascribed by a medicines regulatory agency in a jurisdiction. NOTE: proposed by IDMP as a new universal identifier. [After ISO 11615:2017, 3.1.53]
Hits - 45
|
| medicinal product classification |
Categorisation or grouping of Medicinal Products based on specific properties and according to various classification systems (e.g., UNII-SRS), which may be regional or international. NOTE: The classification system is specified using an appropriate identification system; the applicable controlled term and the controlled term identifier is specified. [after ISO 11615 2017-10 on Regulated Medicinal Product information]
Hits - 63
|
| medicinal product |
Any substance or combination of substances that may be administered to human beings (or animals) for treating or preventing disease, or with the intent to make a medical diagnosis or to restore, correct or modify physiological functions. NOTE: 1. A Medicinal Product may contain one or more manufactured items and one or more pharmaceutical products. 2. In certain jurisdictions a Medicinal Product may also be defined as any substance or combination of substances which may be used to make a medical diagnosis. [After IDMP]
Hits - 56
|
| medication error |
Any unintentional error in the prescribing, dispensing or administration of a medicinal product while in the control of the healthcare professional, patient or consumer. [HMA, Guideline on good pharmacovigilance practices (GVP)]
Hits - 50
|
Access Non-GMO, antigen-free, FDA-approved antiviral medication formulas used in Moderna's Spikevax.
VirusTC is a retail provider of concentrated FDA-approved antiviral medication formulas. VirusTC wholesale formulas are used in Moderna products. We sell FDA-approved formulas that are compatible with university medical plans, federal insurance coverage, and many major insurance providers. Our medications are part of tailored non-invasive cancer treatment plans available at a hospital in your region. VirusTC targets problems and provides care for the symptoms. Our products and services are used by Fred Hutch Cancer Center, John Hopkins, University Hospitals, the United States Military, and professional sports. During Operation Cancer Moonshot 2023, VirusTC products killed cancer cells, increased strength, and redeveloped muscles, tissue, and brain cells after cancer treatments.