Glossaries
Glossaries
| Term | Definition |
|---|---|
| curriculum vitae (CV) |
Document that outlines a person's educational and professional history.
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| CUI (common unique identifier) |
A code used in the Enterprise Vocabulary System (EVS) to link a particular concept across one or more terms.
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| CTCAE (Common Terminology Criterion for Adverse Events) |
Standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in cancer clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. NOTE: CTCAE is often used in study adverse event summaries and Investigational New Drug (IND) reports to the Food and Drug Administration. [After NCI]
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| crossover trial |
A trial design for which subjects function as their own control and are assigned to receive investigational product and controls in an order determined by randomizations, typically with a washout period between the two products. [After ICH E9]
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| cross-sectional study |
A study that measures the prevalence of health outcomes or determinants of health, or both, in a population at a point in time or over a short period. [After British Medical Journal, Epidemiology for the uninitiated] See also observational study.
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| cross-labeled product |
An investigational drug, device, or biological product packaged separately that, according to its proposed labeling, is intended for use only with another investigational or approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect. NOTE: In the case where an approved product is combined with an investigational product, upon approval of the cross-labeled product the label of the previously approved product should be modified to reflect the combination status. [After 21 CFR 3.2 (e) FAQ] See also combination product, single-entity product, co-packaged product.
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| criterion validation (COA) |
Establishing the extent to which the scores of a clinical outcome assessment instrument are related to a known gold standard measure of the same concept. For most COAs clinical outcome assessments (COAs), criterion validity cannot be measured because there is no gold standard. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation.
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criterion validation (re COA) |
| CRF data |
Subset of clinical trial data that are entered into fields on a case report form.
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| CRF (paper) |
Case report form in which the data items are linked by the physical properties of paper to particular pages. NOTE: Data are captured manually and any comments, notes, and signatures are also linked to those data items by writing or typescript on the paper pages. See also eCRF, case report form.
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| covariate (prognostic) |
Factor or condition that influences outcome of a trial. [ADaM]
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| correlation |
The degree to which two or more variables are related. Typically the linear relationship is measured with either Pearson's correlation or spearman's Rho. NOTE: Correlation does not necessarily mean causation. [After Hyperstat Online Glossary; CDISC ADaM]
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| coordinating investigator |
An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial. NOTE: Depending on the scope of the trial, coordination could be across centers/sites in a region, across regions, or within a nation. [ICH E6] See also investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator.
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| coordinating committee |
A committee that a sponsor may organize to coordinate the conduct of a multicenter trial. [ICH E6]
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| controlled vocabulary |
A finite set of values that represent the only allowed values for a data item. These values may be codes, text, or numeric. See also codelist.
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controlled terminology |
| controlled study |
A study in which a test article is compared with a treatment that has known effects (active control), no treatment, placebo, or dose comparison concurrent control, or external (historic) control. [21 CFR 314.126 and ICH E10]. See also control, comparator (product), control group.
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