CDISC Clinical Research Glossary

The latest version of the glossary, providing hundreds of definitions for key terminology related to clinical research.
Dec 01, 2010
By Applied Clinical Trials Editors

Glossary Terms

510(k). Premarket Notification (PMN) required for certain medical devices. See http://www.fda.gov/cdrh/510khome.html


CDISC Glossary Project
abbreviation. A set of letters that are drawn from a word or from a sequence of words and that are used for brevity in place of the full word or phrase. NOTE: An abbreviation is NOT pronounced as a word, but each letter is read in sequence (e.g., NIH). Compare to acronym.

absorption. The process by which medications reach the blood stream when administered other than intravenously, for example, through nasal membranes. See also ADME (pharmacokinetics).

acronym. 1. A word formed from the beginning letters (e.g., ANSI) or a combination of syllables and letters (e.g., MedDRA) of a name or phrase. 2. The short set of letters that identify a clinical study protocol. NOTE: An acronym is usually pronounced as a word, not by speaking each letter individually. Compare to abbreviation.

action letter. An official communication from FDA to an NDA sponsor announcing an agency decision. See also approval letter, approvable letter, not-approvable letter.

activation. Enabling an eClinical trial system to capture data; usually used for EDC systems.

admission criteria. Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristics match any single one of the exclusion criteria set up for the study. See also inclusion criteria, exclusion criteria.

adverse drug experience. See adverse drug reaction.

adverse drug reaction (ADR). Any noxious and unintended response associated with the use of a drug in humans. 1. Post-approval: an adverse event that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function. 2. Pre-approval: an adverse event that occurs at any dose and where a causal relationship is at least a reasonable possibility. NOTE: FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, "whether or not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality. [WHO Technical Report 498(1972); ICH E2A]

adverse event (AE). Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. "[Modified from ICH E2A]" Synonyms: side effect, adverse experience. See also serious adverse event, serious adverse experience.

adverse experience. See adverse event.

adverse reaction. See adverse drug reaction.


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