Glossaries
Glossaries
| Term | Definition |
|---|---|
| control of electronic records |
To prepare and maintain case histories and other records for regulated clinical investigations or other regulated research. NOTE: Control is often used as a casual synonym for the terms in 21 CFR 312.62 requiring investigative sites to prepare, maintain, and retain adequate and accurate case histories. [After 1. 21 CFR 11; 2. CSUCT] See also record.
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| control group |
The group of subjects in a controlled study that receives, for example, no treatment, a standard treatment, or a placebo. [21 CFR 314.126] See also control, controlled study, arm (protocol).
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| control |
A comparator against which the study treatment is evaluated [e.g., concurrent (placebo, no treatment, dose-response, active), and external (historical, published literature, synthetic data)]. [After ICH E10]. See also comparator (product), control group, controlled study, arm (protocol), synthetic data.
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| contract research organization (CRO) |
A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. [ICH E6 Glossary]
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| contract |
A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract. [ICH E6 Glossary]
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| contingent subject trial contact |
Planned response to an anticipated but conditional event in a clinical trial. [CDISC Trial Design Project]
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| context of use |
In the context of clinical outcomes, a comprehensive statement that fully and clearly describes and justifies the way a COA is to be used and the drug development-related purpose of the use. NOTE: The context of use defines the boundaries within which the available data adequately justify use of the COA and describes important criteria regarding the circumstances under which the COA is qualified. [FDA Clinical Outcome Assessment (COA) Glossary]
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| content validity |
The extent to which a variable (for example, a rating scale) measures what it is supposed to measure. [ICH E9 Glossary] evidence from qualitative research demonstrating that the instrument measures the concept of interest, including evidence that the items and domains of an instrument are appropriate and comprehensive, relative to its intended measurement concept, population, and use. NOTE: Testing other measurement properties will not replace or rectify problems with content validity. [FDA Final PRO Guidance]
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| content validation (COA) |
Establishing from qualitative research the extent to which the clinical outcome assessment (COA) instrument measures the concept of interest including evidence that the items and domains of an instrument are appropriate and comprehensive relative to its intended measurement concept, population, and use. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation.
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content validation (re COA) |
| consumer safety officer (CSO) |
FDA official who coordinates the review process of various applications.
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| construct validation (COA) |
Establishing, using quantitative methods, the extent to which the relationships among items, domains, and concepts of a clinical outcome assessment (COA) conform to a priori hypotheses concerning logical relationships that should exist with other measures or characteristics of patients and patient groups. [NIH-FDA BEST (Biomarkers, Endpoints, and other Tools) Resource, https://www.ncbi.nlm.nih.gov/books/NBK338448/] See also validation.
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construct validation (re COA) |
| consent form |
Document used during the informed consent process that is the basis for explaining to potential subjects the risks and potential benefits of a study and the rights and responsibilities of the parties involved. NOTE: The informed consent document provides a summary of a clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains an individual's rights as a subject. it is designed to begin the informed consent process, which consists of conversations between the subject and the research team. if the individual then decides to enter the trial, s/he gives her/his official consent by signing the document. Informed consent is sometimes administered electronically, i.e., eICF. See also informed consent.
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informed consent form |
| conformity assessment |
The process by which compliance with the EMA's essential requirements is assessed. See also Notified Body (NB).
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| confirmatory trial |
Phase 3 trial with results that confirm the preliminary evidence accumulated in earlier phases that a drug is safe and effective for use for the intended indication and recipient population. [After ICH E8] See also non-confirmatory trial result, pragmatic trial. Compare to exploratory trial.
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| confidentiality |
Prevention of disclosure to other than authorized individuals of a sponsor's proprietary information or of a subject's identity. [ICH E6 Glossary]
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