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?:definition
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A discrete, structured plan (that persists over time) of 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 term \'protocol\' is somewhat overloaded and must be qualified to provide semantic context. Therefore the term \'study protocol\' was chosen to disambiguate it from other protocols. In previous versions of BRIDG, there was one class for StudyProtocol. However this too represented multiple distinct aspects of the semantics of study protocol, each of which have now been split into separate classes:- The StudyProtocol class represents the content of the study protocol and can exist even before the information is put into document form. - The details of the structured plan for the study protocol are represented by the StudyProtocolVersion, so named because any aspect of the definition can change from version to version. These details include, but are not limited to, the characteristics, specifications, objective(s), background, the pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization).- The protocol and its versions can each be represented in document form, respectively StudyProtocolDocument and StudyProtocolDocumentVersion. A StudyProtocolDocument groups the various document versions (StudyProtocolDocumentVersions).- The conduct of a study based on a study protocol definition is represented by the StudyExecution class.
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