: Public Class
| Created: |
8/7/2009 5:03:46 PM |
| Modified: |
8/30/2019 11:09:33 PM |
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 Project: |
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| Author: |
BRIDG SCC |
| Version: |
1.0 |
| Phase: |
1.0 |
| Status: |
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| Complexity: |
Easy |
| Difficulty: |
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| Priority: |
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| Multiplicity: |
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| Advanced: |
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| UUID: |
{6F9BDAB9-4E31-4331-89BA-7A065CE4C11C} |
| Appears In: |
UML-Based Comprehensive BRIDG Model Diagram, BRIDG BackBone, View PR: Protocol Representation, Study Versioning, View SC: Study Conduct, SDTM IG v3.2, StudySite and StudySubject, Study Management, Structured Protocol - Core Protocol Concepts, National Biomedical Imaging Archive (NBIA), Documents and Document Versions, Structured Protocol - Backbone |
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/>
- Associations To
- Tagged Values
- Other Links
| Element |
Source Role |
Target Role |
StudyProtocol
Class
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Name: representingStudyProtocolDocument
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Name: representedStudyProtocol
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 Details:
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/>
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| Tag |
Value |
| Map:CTRPv3.8 |
StudyProtocol.document(Document) |
Details:
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| Map:CTRv1.0 |
StudyProtocolDocument |
Details:
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| 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):
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