Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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 [from PRO Draft Guidance Glossary]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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| clinical trial data |
Data collected in the course of a clinical trial. See also clinical trial information.
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| clinical trial authorization |
Authorization granted by a Medicines Regulatory Agency to conduct a clinical trial in a jurisdiction. NOTE: If an ethical committee allows a trial to proceed it is called an approval to proceed. [After ISO 11615:2017, 3.1.12]
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| clinical trial |
A research investigation involving human subjects that is designed to answer specific questions about the safety and efficacy of a biomedical intervention (drug, treatment, device) or new ways of using a known drug, treatment, or device). NOTE: NIH Office of Science Policy further specifies that a clinical trial is a type of research study that prospectively assigns subjects to interventions, and the EU clinical trial regulations set forth 3 specific conditions, any one of which qualifies a study as a clinical trial. These conditions include applying diagnostic or monitoring procedures not used in normal clinical practice to subjects. [After ICH E6 [R2], EU CTR 2014] See also clinical study, clinical investigation, randomized controlled trial (RCT).
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Interventional Clinical Trial; Interventional Study |
| clinical study report |
A written description of a study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analysis are fully integrated into a single report. NOTE: For further information, see the ICH Guideline for Structure and Content of Clinical Study Reports. [ICH E6 Glossary]
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