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?:definition
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A variant or snapshot of the study protocol at a particular point in time. EXAMPLE(S): OTHER NAME(S): NOTE(S): A change in virtually any aspect of a study protocol can trigger the creation of a new study protocol version. The kinds of changes that can trigger creation of a new study protocol version include (but are not limited to) changes to the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization), supporting documents such as informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc. The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion and all their associations. - The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form. - The StudyProtocolVersion class represents the details of the study protocol that may change over time. - The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions. - The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time.
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