Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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]
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| internal consistency |
Pertaining to data that do not include contradictions.
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| 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]
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| interim analysis(es) |
Analysis comparing intervention groups at any time before the formal completion of the trial, usually before recruitment is complete. [CONSORT statement]
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| interim analysis schedule |
The time/information points at which interim analyses are planned.
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| intercurrent event |
An event(s) occurring after treatment initiation that affects either the interpretation or the existence of the measurements associated with the clinical question of interest. [ICH E9 Addendum on Estimands]
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| interaction (qualitative and quantitative) |
The situation in which a treatment contrast (e.g., difference between investigational product and control) is dependent on another factor (e.g., center). A quantitative interaction refers to the case where the magnitude of the contrast differs at the different levels of the factor, whereas for a qualitative interaction, the direction of the contrast differs for at least one level of the factor. [ICH E9 Glossary]
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| inter-rater reliability |
The property of scales yielding equivalent results when used by different raters on different occasions. [ICH E9]
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| intention-to-treat |
The principle that asserts that the effect of a treatment policy can be best assessed by evaluating the basis of the intention to treat a subject (i.e., the planned treatment regimen) rather than the actual treatment given. NOTE: This has the consequence that subjects allocated to a treatment group should be followed up, assessed, and analyzed as members of that group irrespective of their compliance with the planned course of treatment. The principle is intended to prevent bias caused by loss of participants that may reflect non-adherence to the protocol and disrupt baseline equivalence established by random assignment. [ICH E9; after CONSORT statement]
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| intended use |
The specific clinical circumstance or purpose for which a medical product or test is being developed. NOTE: In the regulatory context, this term refers to the "Statement of Intended Use" prepared by the persons legally responsible for the labeling of medical products. [after NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/]
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| instrument |
A means to capture data (e.g., questionnaire, diary) plus all the information and documentation that supports its use. NOTE: Generally, instruments include clearly defined methods and instructions for administration or responding, a standard format for data collection, and well-documented methods for scoring, analysis, and interpretation of results. [from PRO Draft Guidance] Compare to questionnaire, survey (see Comments on Draft PRO Guidance, April 4, 2006, by ISOQOL, p. 8).
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| institutional review board (IRB) |
An independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a study by, among other things, reviewing, approving, and providing continuing review of study protocol and of the methods and material to be used in obtaining and documenting informed consent of the study subjects. [ICH E6 1.31]
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committee for the protection of human subjects; independent ethics committee; independent review board |
| institution (medical) |
Any public or private entity or agency or medical or dental facility where clinical trials are conducted. [ICH]
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| inspection |
The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies). [ICH] See also audit.
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| ingredient |
Active and/or inactive material used in pharmaceutical product. [After ISO 11615:2017, 3.1.28]
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