| Created: | 3/7/2007 11:20:55 AM |
| Modified: | 8/26/2017 2:46:29 AM |
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DEFINITION:<br/>An organization or person that assumes responsibility for producing and submitting documentation to a regulatory authority to seek approval for testing, marketing and the continuation of marketing of new drugs or devices.<br/><br/>EXAMPLE(S):<br/>pharmaceutical company<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
- Attributes
- Associations To
- Associations From
- Tagged Values
- Constraints
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Public IVL<TS.DATETIME> effectiveDateRange |
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Map:RPS2=(New content)
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| Element | Source Role | Target Role |
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Organization Class |
Name: performedRegulatoryApplicationSponsor |
Name: performingOrganization |
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DESCRIPTION:<br/>Each RegulatoryApplicationSponsor might be a function performed by one Organization. Each Organization might function as one or more RegulatoryApplicationSponsor.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
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HealthcareProvider Class |
Name: performedRegulatoryApplicationSponsor |
Name: performingHealthcareProvider |
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Details:
DESCRIPTION:<br/>Each RegulatoryApplicationSponsor might be a function performed by one HealthcareProvider. Each HealthcareProvider might function as one or more RegulatoryApplicationSponsor.<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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«DEPRECATED» Submission Class |
Name: submittedSubmission |
Name: submittingRegulatoryApplicationSponsor |
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Details:
DESCRIPTION:<br/>Each Submission always is submitted by one RegulatoryApplicationSponsor. Each RegulatoryApplicationSponsor always submits one or more Submission.<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:caAERSv2.2 | INDHolder |
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| Map:CTRPv1.0 | RegulatoryApplicationSponsor |
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| Map:CTRRr3 | RegulatoryApplicationSponsor |
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| Map:CTRv1.0 | RegulatoryApplicationSponsor |
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| Map:ICSRr2 | holder (in R_Product) |
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| Map:ICSRr2 | role (in R_Product) |
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| Constraint | Type | Status |
| be a function performed by Exclusive Or | Invariant | Approved |
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Details:
A RegulatoryApplicationSponsor might be a function performed by one and only one of the following: Organization, HealthcareProvider.<br/>
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| be a function performed by actualIndicator Qualifier | Invariant | Approved |
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Details:
Only Organization with actualIndicator = "true" is valid.<br/>
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