PropertyValue
?:definition
  • A plan at a particular point in time for a formal investigation to assess the utility, impact, pharmacological, physiological, and/or psychological effects of a particular treatment, procedure, drug, device, biologic, food product, cosmetic, care plan, or subject characteristic. NOTE(S): The notion of a study includes (but is not limited to) the design, statistical considerations and activities to test a particular hypothesis or answer a particular question that is the basis of the study. The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational. Subjects may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The complete notion of the study is represented by the Study class and all its associations which make explicit the details identified in the StudyProtocolDocument.
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