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Casuality assessment
Casuality assessment Determining whether there is a reasonable possibility that the drug caused or contributed to an adverse event. It includes assessing temporal relationships, dechallenge/rechallenge information, association (or lack of association) with underlying disease, and the presence (or absence) of a more likely cause.
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Event
A set of outcomes. Cardiovascular events might include a heart attack and gastrointestinal events a GI bleed. The use of the term "event" in medicine comes from probability theory.
Temporal
Having to do with the side of the head.
Association
1. In dysmorphology (the study of birth defects), the nonrandom occurrence in two or more individuals of a pattern of multiple anomalies (birth defects) not known to be a malformation syndrome (such as Down syndrome), a malformation sequence (of events) or what is called a polytopic field defect (in which all of the defects are concentrated in one particular area of the body). An example of an association in dysmorphology is the VACTERL association of birth defects. 2. In genetics, the occurrence together of two or more characteristics more often than would be expected by chance alone. An example of association involves a feature on the surface of white blood cells called HLA (HLA stands for human leukocyte antigen). A particular HLA type, HLA type B-27, is associated with an increased risk for a number of diseases including ankylosing spondylitis. The extent of the association is enormous. Ankylosing spondylitis is 87 times more likely to occur in people with HLA B-27 than in the general population.
Disease
Illness or sickness often characterized by typical patient problems (symptoms) and physical findings (signs). Disruption sequence: The events that occur when a fetus that is developing normally is subjected to a destructive agent such as the rubella (German measles) virus.
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Cardiac arrhythmia
Irregular or abnormally slow or rapid beating of the heart.
Carotid artery
A major artery in the neck that supplies blood to the head and brain.
Carotid endarterectomy
Surgical removal of deposits (which cause restricted blood flow, or are the source of an embolus) in the walls of the carotid artery.
Case report form (CRF)
A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.
Categorical data
Data evaluated by sorting values into various categories (for example, severe, moderate, and mild).
Casuality assessment
Cerebral infarct
A localised area of cell death in the brain due to inadequate blood flow.
Circadian rhythm
Biological timing and rhythmicity that, in humans, is characterised by cycles of approximately 24 hours. Synonym: biological clock.
Clean database (or file)
One from which errors have been eliminated and in which measurements and other values are provided in the same units.
Clinical trial
A research study that involves the administration of a test regimen or experimental treatment (eg. a new drug or therapy), to humans to evaluate its efficacy and safety. See also phases of clinical trials.
Clinical trial/study report
A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report (see the ICH Guideline for Structure and Content of Clinical Study Reports).
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