Glossaries
Glossaries
| Term | Definition |
|---|---|
| confidence interval (CI) |
A measure of the precision of an estimated value. The interval represents the range of values, consistent with the data, that is believed to encompass the "true" value with high probability (usually 95%). The confidence interval is expressed in the same units as the estimate. Wider intervals indicate lower precision; narrow intervals, greater precision. [CONSORT Statement]
Hits - 41
|
| concerned member state (CMS) |
A classification of a Member States in the Mutual Recognition Procedure (MRP) in the European authorization route resulting in a mutually recognized product. In the Mutual Recognition Procedure, one or more Member States that is a CMS is asked to mutually recognize the Market Authorization of the Reference Member State (RMS). [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem.html] See also Mutual Recognition Procedure (MRP) and Reference Member State (RMS).
Hits - 67
|
| concept of interest |
In the context of clinical outcomes, the thing measured by a COA assessment (e.g., pain intensity). [After Clinical Outcome Assessment (COA) Glossary of Terms FDA FDA eCOA Glossary]
Hits - 97
|
| concept |
Discrete notion having a single meaning. In a controlled vocabulary a concept is mapped to one or more of the words that convey its meaning.
Hits - 60
|
| computer application |
Software designed to fill specific needs of a user; for example, software for navigation, project management, or process control.
Hits - 59 Synonyms -
application software |
| compliance (in relation to trials) |
Adherence to trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. [Modified ICH E6 Glossary]
Hits - 65
|
| Competent Authority (CA) |
The regulatory body charged with monitoring compliance with the national statutes and regulations of European Member States.
Hits - 67
|
| compendial name |
A name within a pharmaceutical compendium that designates a small or large molecule substance that complies with compendial standards for strength, quality, and purity. NOTE: Used for all drugs within the US. [After USP Nomenclature Guidelines (last revision on March 30, 2020)] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name.
Hits - 47
|
| comparator (product) |
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. [ICH E6 Glossary] See also control.
Hits - 52
|
| comparative study |
One in which the investigative drug is compared against another product, either active drug or placebo.
Hits - 51
|
| Common Technical Document |
A format agreed upon by ICH to organize applications to regulatory authorities for registration of pharmaceuticals for human use. [ICH] See also eCTD.
Hits - 55
|
| common data element (CDE) |
A structured item characterized by a stem and response options together with a history of usage that can be standardized for research purposes across studies conducted by and for NIH. NOTE: The mark up or tagging facilitates document indexing, search and retrieval, and provides standard conventions for insertion of codes. [NCI, CaBIG]. See also item, item (PRO), stem, data element, data element identifier.
Hits - 64
|
| commercially confidential information (CCI) |
Any information contained in clinical reports or other documents that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the company (the Marketing Application Holder) and cause harm (if disclosed). [After EMA Policy 0070 implementation Guide]
Hits - 48
|
| combination product |
A product composed of two or more different types of medical products (i.e., a combination of a drug, device, and/or biological product with one another and are referred to as "constituent parts" of the combination product). NOTE: A combination product might be a single-entity product, a co-packaged product or a cross-labeled product. [After 21 CFR 3.2 (e)] See also single-entity product, co-packaged product, cross-labeled product.
Hits - 49
|
| cohort study |
Study of a group of individuals, some of whom are exposed to a variable of interest, in which subjects are followed over time. Cohort studies can be prospective or retrospective. [After AMA Manual of Style] See also prospective study, observational study, retrospective study, case-control study, cohort.
Hits - 75
|
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.