: Public Class
Created: |
7/11/2008 10:13:25 AM |
Modified: |
8/26/2017 2:00:41 AM |
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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: |
{E550C118-F94A-4977-A6CB-0BD885955BF0} |
Appears In: |
UML-Based Comprehensive BRIDG Model Diagram, View CM: Common, View RG: Regulatory, View SC: Study Conduct, View IM: Imaging, Organization, Organization-Related Classes - no attributes, StudySite and StudySubject, Performer, Oncology & Imaging View, ClinicalTrials.gov |
DEFINITION:<br/>An organization with monitoring, regulatory, or supervisory authority over biomedical research at the local, regional, national, or international level.<br/><br/>EXAMPLE(S):<br/>Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, Food and Drug Administration (FDA) in the USA, World Health Organization (WHO), Institutional Review Board (IRB), Ethics committee, Research ethics board<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
- Associations To
- Associations From
- Tagged Values
- Other Links
Element |
Source Role |
Target Role |
Organization
Class
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Name: performedOversightAuthority
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Name: performingOrganization
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 Details:
DESCRIPTION:<br/>Each OversightAuthority always is a function performed by one Organization. Each Organization might function as one OversightAuthority.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
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Element |
Source Role |
Target Role |
StudyOversightAuthority
Class
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Name: performedStudyOversightAuthority
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Name: performingOversightAuthority
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 Details:
DESCRIPTION:<br/>Each StudyOversightAuthority always is a function performed by one OversightAuthority. Each OversightAuthority might function as one or more StudyOversightAuthority.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
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Tag |
Value |
Map:CTRR |
Oversight Authority |
 Details:
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Map:CTRRr3 |
OversightAuthority |
 Details:
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Map:CTRv1.0 |
OversightAuthority |
 Details:
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Object |
Type |
Connection |
Direction |
Notes |
OversightCommittee |
Class |
Generalization |
From |
DESCRIPTION:
Each OversightCommittee always specializes one OversightAuthority. Each OversightAuthority might be specialized by one OversightCommittee.
DEFINITION:
EXAMPLE(S):
OTHER NAME(S):
NOTE(S):
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«DEPRECATED» RegulatoryAuthority |
Class |
Generalization |
From |
DESCRIPTION:
Each RegulatoryAuthority always specializes one OversightAuthority. Each OversightAuthority might be specialized by one RegulatoryAuthority.
DEFINITION:
EXAMPLE(S):
OTHER NAME(S):
NOTE(S):
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