| Created: | 6/18/2008 8:20:13 AM |
| Modified: | 5/11/2019 12:20:42 AM |
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| Advanced: |
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DEFINITION:<br/>A sponsor that initiates the investigation and is legally responsible for the study.<br/><br/>EXAMPLE(S):<br/>Government Agency examples: National Cancer Institute (NCI), National Institutes of Health (NIH), National Cancer Research Institute (NCRI)<br/><br/>Private industry examples: pharmaceutical companies<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
- Attributes
- Associations To
- Associations From
- Tagged Values
- Constraints
| Attribute | ||
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Public BL primaryIndicator |
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Details:
Map:CTRv1.0=StudyLegalSponsor.primaryIndicator Map:WHO=Primary Sponsor Map:WHO=Secondary Sponsor
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| Element | Source Role | Target Role |
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HealthcareProvider Class |
Name: performedStudyLegalSponsor |
Name: performingHealthcareProvider |
 Details:
DESCRIPTION:<br/>Each StudyLegalSponsor might be a function performed by one HealthcareProvider. Each HealthcareProvider might function as one or more StudyLegalSponsor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
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StudyProtocolVersion Class |
Name: sponsoringStudyLegalSponsor |
Name: sponsoredStudyProtocolVersion |
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Details:
DESCRIPTION:<br/>Each StudyLegalSponsor always is responsible for one StudyProtocolVersion. Each StudyProtocolVersion might be the responsibility of one or more StudyLegalSponsor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
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Organization Class |
Name: performedStudyLegalSponsor |
Name: performingOrganization |
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Details:
DESCRIPTION:<br/>Each StudyLegalSponsor might be a function performed by one Organization. Each Organization might function as one or more StudyLegalSponsor.<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 |
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PerformedProtocolDeviation Class |
Name: authorizedPerformedProtocolDeviation |
Name: authorizingStudyLegalSponsor |
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Details:
DESCRIPTION:<br/>Each PerformedProtocolDeviation might be authorized by one StudyLegalSponsor. Each StudyLegalSponsor might authorize one or more PerformedProtocolDeviation.<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:C3PR | StudySponsor |
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Details:
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| Map:CTRR | Secondary Sponsor |
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Details:
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| Map:CTRv1.0 | StudyLegalSponsor |
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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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| Map:NBIAv6.4 | Clinical_Trial_Sponsor |
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Details:
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| Constraint | Type | Status |
| be a function performed by Exclusive Or | Invariant | Approved |
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Details:
A StudyLegalSponsor is a function performed by one and only one of the following: HealthcareProvider, Organization.<br/>
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