: Public Class
Created: 8/7/2009 5:03:46 PM
Modified: 8/30/2019 11:09:33 PM
DEFINITION:<br/>A document that describes a study protocol.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>A study protocol document 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.<br/>- 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.<br/>- The StudyProtocolVersion class represents the details of the study protocol that may change over time.<br/>- The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions.<br/>- 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.<br/>
Element Source Role Target Role
Name: representingStudyProtocolDocument
Name: representedStudyProtocol
DESCRIPTION:<br/>Each StudyProtocolDocument always represents one StudyProtocol. Each StudyProtocol might be represented in one StudyProtocolDocument.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Tag Value
Map:CTRPv3.8 StudyProtocol.document(Document)
Map:CTRv1.0 StudyProtocolDocument
Object Type Connection Direction Notes
Document Class Generalization To DESCRIPTION: Each StudyProtocolDocument always specializes one Document. Each Document might be specialized by one StudyProtocolDocument. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):