Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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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| confidence interval (CI) |
A measure of the precision of an estimated value. The interval represents the range of values, consistent with the data, that is believed to encompass the "true" value with high probability (usually 95%). The confidence interval is expressed in the same units as the estimate. Wider intervals indicate lower precision; narrow intervals, greater precision. [CONSORT Statement]
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| concerned member state (CMS) |
A classification of a Member States in the Mutual Recognition Procedure (MRP) in the European authorization route resulting in a mutually recognized product. In the Mutual Recognition Procedure, one or more Member States that is a CMS is asked to mutually recognize the Market Authorization of the Reference Member State (RMS). [After Heads of Medicines Agencies (HMA) website http://www.hma.eu/medicinesapprovalsystem.html] See also Mutual Recognition Procedure (MRP) and Reference Member State (RMS).
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| concept of interest |
In the context of clinical outcomes, the thing measured by a COA assessment (e.g., pain intensity). [After Clinical Outcome Assessment (COA) Glossary of Terms FDA FDA eCOA Glossary]
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| concept |
Discrete notion having a single meaning. In a controlled vocabulary a concept is mapped to one or more of the words that convey its meaning.
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| computer application |
Software designed to fill specific needs of a user; for example, software for navigation, project management, or process control.
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application software |
| compliance (in relation to trials) |
Adherence to trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. [Modified ICH E6 Glossary]
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| Competent Authority (CA) |
The regulatory body charged with monitoring compliance with the national statutes and regulations of European Member States.
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| compendial name |
A name within a pharmaceutical compendium that designates a small or large molecule substance that complies with compendial standards for strength, quality, and purity. NOTE: Used for all drugs within the US. [After USP Nomenclature Guidelines (last revision on March 30, 2020)] See also proprietary name, generic name, international nonproprietary name (INN), established name, medicinal product name.
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| comparator (product) |
An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. [ICH E6 Glossary] See also control.
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| comparative study |
One in which the investigative drug is compared against another product, either active drug or placebo.
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| Common Technical Document |
A format agreed upon by ICH to organize applications to regulatory authorities for registration of pharmaceuticals for human use. [ICH] See also eCTD.
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