Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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.
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| 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]
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| 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.
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| 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.
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| cohort |
A group of individuals who share a common exposure, experience or characteristic or a group of individuals followed-up or traced over time in a cohort study. [AMA Manual of Style] See also cohort study.
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| cognitive debriefing |
A qualitative research tool used to determine whether concepts and items are understood by patients in the same way that PRO instrument developers intend. NOTE: Cognitive debriefing interviews involve incorporating follow-up questions in a field test interview to gain better understanding of how patients interpret questions asked of them and to collect and consider all concepts elicited by an item. [from PRO Draft Guidance Glossary]
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| coding |
In clinical trials, the process of assigning data to categories for analysis. NOTE: Adverse events, for example, may be coded using MedDRA.
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| codelist |
Finite list of codes and their meanings that represent the only allowed values for a data item. A codelist is one type of controlled vocabulary. See also controlled vocabulary.
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| co-packaged product |
Two or more separate products packaged together in a single package or as a unit and composed of drug and device products, device and biological products, or biological and drug products. [After 21 CFR 3.2 (e) FAQ] See also combination product, single-entity product, cross-labeled product.
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| clinician-reported outcome (ClinRO) |
A type of clinical outcome assessment. A measurement based on a report that comes from a trained health-care professional after observation of a patient's health condition. [After BEST Resource]
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| clinical trial results registry |
A web-based publicly accessible platform for providing structured summary results information about clinical trials. See also clinical trial registry.
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| clinical trial registry |
A web-based publicly accessible platform for providing structured information about clinical trials. NOTE: Such registries help patients, family members, health care professionals, researchers, and the public identify studies in which they might participate. Some registries include clinical trial results. Examples include: EU Clinical Trials Register (EU CTR), for studies in the EU or the EEA after 1 May 2001; ClinicalTrials.gov, a web-based resource from the National Library of Medicine (NLM) in the US. [After International Committee of Medical Journal Editors]
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| clinical trial materials |
Complete set of supplies provided to an investigator by the trial sponsor.
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| clinical trial information |
Data collected in the course of a clinical trial or documentation related to the integrity or administration of that data. A superset of clinical trial data.
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| clinical trial exemption (CTX) |
A scheme that allows sponsors to apply for approval for each clinical study in turn, submitting supporting data to the Medicines Control Agency (MCA), which approves or rejects the application (generally within 35 working days). NOTE: Approval means that the company is exempt from the requirement to hold a clinical trial certificate (CTC). [UK]
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