Glossaries
Glossaries
| Term | Definition |
|---|---|
| item (PRO) |
An individual question, statement, or task (and its standardized response options) that is evaluated by the patient to address a particular concept. [FDA Clinical Outcome Assessment (COA) Glossary] See also item generation, response option.
Hits - 93
|
| item |
A representation of a clinical variable, fact, concept, or instruction in a manner suitable for communication, interpretation, or processing by humans or by automated means. NOTE: Items are collected together to form item groups. [CDISC] Compare to data item, item (PRO).
Hits - 72
|
| investigator/institution |
An expression meaning "the investigator and/or institution, where required by the applicable regulatory requirements" with respect to the transfer or assignment of responsibilities. [After ICH E6 1.35] See also coordinating investigator, investigator, principal investigator, site investigator, sponsor-investigator, sub-investigator.
Hits - 59
|
| investigator's brochure |
A compilation of the clinical and non-clinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects.
Hits - 47
|
| investigator |
An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team). [21 CFR 50.3] See also sponsor-investigator, site investigator, principal investigator, coordinating investigator, sub-investigator.
Hits - 71
|
| investigational medicinal product |
A pharmaceutical form of an active ingredient being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. Reference products and placebos are also considered investigational medicinal products in a clinical trial. [After E6(R2) Good Clinical Practice (GCP) -- Step 4 (final), 9 November 2016 -- Glossary] See also authorised investigational medicinal product, experimental intervention.
Hits - 75 Synonyms -
Investigational Product |
| investigational device |
A device that is assessed in a clinical investigation. [REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices] See also investigational product, medical device.
Hits - 57
|
| intervention |
An activity that produces an effect, or that is intended to alter the course of a disease in a patient or population. This is a general term that encompasses the medical, social, behavioral, and environmental acts that can have preventive, therapeutic, or palliative effects. (NCI) See also investigational product, experimental intervention, vaccine, medical device, diagnostic device.
Hits - 76
|
| interoperability |
Ability of two or more systems or components to exchange information and to use the information that has been exchanged. [IEEE Standard Computer Dictionary]. See also syntactic, semantic, semantic interoperability.
Hits - 100
|
| internet service provider (ISP) |
A company that provides access to the internet for individuals and organizations.
Hits - 77
|
| internet |
A global system of computer networks that provides the common TCP IP infrastructure for e-mail, the World Wide Web, and other online activities.
Hits - 60
|
| international nonproprietary name (INN) |
Unique name for a drug substance (pharmaceutical ingredient) that is globally recognized and public property. NOTE: The INN name is established by the World Health Organization (WHO). [After WHO, Health products policy and standards, INN and medicines classification] See also proprietary name, generic name, established name, medicinal product name, compendial name, active substance.
Hits - 76
|
| international birth date (IBD) |
The date of the first marketing authorization for a new product granted to any company in any country in the world. NOTE: Used for Periodic Safety Update Report (PSUR). [After ICH E2C(R2), Appendix A]
Hits - 64
|
| internal consistency |
Pertaining to data that do not include contradictions.
Hits - 68
|
| interim clinical trial/study report |
A report of intermediate results and their evaluation based on planned analyses performed during the course of a trial. [ICH]
Hits - 71
|
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.