: Public Class
Created: 5/21/2010 4:02:32 PM
Modified: 8/26/2019 1:17:43 PM
DEFINITION:<br/>A version of a document, memo or brief that enumerates the differences between two versions of a study protocol document.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/>Amendment<br/><br/>NOTE(S):<br/>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) that are applied to a protocol to create a new version of the protocol.<br/>
Tag Value
Map:CTRv1.0 AmendmentChangeSummaryVersion
Map:PSCv2.6 Amendment
Object Type Connection Direction Notes
DocumentVersion Class Generalization To DESCRIPTION: Each AmendmentChangeSummaryVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one AmendmentChangeSummaryVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):