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?:definition
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A variant or snapshot of the study protocol document at a particular point in time. EXAMPLE(S): Version 3 of a breast cancer protocol document. OTHER NAME(S): Amendment NOTE(S): A study protocol document version is one component of the overall concept of a study protocol. 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. The term \'Amendment\' needs to be disambiguated since it sometimes refers to the amended version of the protocol (StudyProtocolDocumentVersion) and other times refers to the summary of changes (AmendmentChangeSummaryVersion).
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