| Created: | 7/11/2008 10:13:25 AM |
| Modified: | 2/27/2019 12:55:32 AM |
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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
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Organization Class |
Name: performedOversightAuthority |
Name: performingOrganization |
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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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StudyOversightAuthority Class |
Name: performedStudyOversightAuthority |
Name: performingOversightAuthority |
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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 |
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| Map:CTRRr3 | OversightAuthority |
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| Map:CTRv1.0 | OversightAuthority |
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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): |
| «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): |