| Created: | 7/11/2008 10:44:20 AM |
| Modified: | 9/18/2013 5:00:39 PM |
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| Advanced: |
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DEFINITION:<br /></p><p>An organization with monitoring, regulatory, or supervisory authority over biomedical research at the local, regional, national, or international level for a particular study.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>NCI, FDA, IRB, etc.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>An NCI sponsored study is monitored by the NCI (or its designate) and required to meet federal regulations per the FDA. Participating sites must comply with their governing IRB requirements and institutional policy. Each of these study oversight authorities (NCI, FDA, IRB) is repsonsible for different aspects of the study.<br /></p>
- Associations To
- Tagged Values
- Constraints
| Element | Source Role | Target Role |
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StudyConduct Class |
Name: overseeingStudyOversightAuthority |
Name: overseenStudyConduct |
 Details:
DESCRIPTION:<br /></p><p>Each StudyOversightAuthority might oversee one StudyConduct. Each StudyConduct might be overseen by one or more StudyOversightAuthority.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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StudyProtocolVersion Class |
Name: overseeingStudyOversightAuthority |
Name: overseenStudyProtocolVersion |
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Details:
DESCRIPTION:<br /></p><p>Each StudyOversightAuthority might oversee one StudyProtocolVersion. Each StudyProtocolVersion might be overseen by one or more StudyOversightAuthority.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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OversightAuthority Class |
Name: performedStudyOversightAuthority |
Name: performingOversightAuthority |
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Details:
DESCRIPTION:<br /></p><p>Each StudyOversightAuthority always is a function performed by one OversightAuthority. Each OversightAuthority might function as one or more StudyOversightAuthority.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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| Tag | Value |
| Map:CTGOV | FDA Regulated Intervention? |
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Details:
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| Map:CTGOV | Data Monitoring Committee? |
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Details:
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| Map:CTRPv1.0 | InterventionalStudyProtocol.FDAregulatedIndicator |
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Details:
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| Map:CTRPv3.8 | StudyRegulatoryAuthority |
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Details:
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| Map:CTRv1.0 | StudyOversightAuthority |
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Details:
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| Map:HSDBv1.0 | [Lead Organization] .Organization Type |
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Details:
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| Constraint | Type | Status |
| oversee Mandatory Qualifier | Invariant | Approved |
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Details:
At least one of the following classes must be known for a StudyOversightAuthority: StudyProtocolVersion, StudyExecution.
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