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Glossary of
Terms
adverse
events: A medical
complaint, change, or possible side effect of any degree of
severity, that may or may not be attributed to the investigational
product.
clinical
trial/study: Any
investigation in human subjects intended to discover or verify
the clinical, pharmacological and/or other pharmacodynamic
effects of an investigational product(s), and/or to study absorption,
distribution, metabolism, and excretion of an investigational
product(s), with the object of ascertaining its safety and/or
efficacy. The terms “clinical trial” and “clinical study” are
synonymous.
confidentiality: Prevention
of disclosure, to other than authorized individuals, of a
sponsor’s proprietary information of a subject’s identity.
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