Difference between revisions of "Sponsor (RPS)"
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==Additional Regional Definitions and Synonyms== | ==Additional Regional Definitions and Synonyms== | ||
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| − | [[Category:RPS Glossary]] | + | ==RPS Modeling Discussion== |
| + | The '''Sponsor''' is one of two defined [[Actors]] in an [[RPS]] message, the other being the [[Regulatory Authority]]. | ||
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| + | The '''Sponsor''' should be identified by a [[Unique Identifier]], either an [[OID]] or a [[UUID]]. If an OID is used, it may be the root OID for all submissions and data in the RPS messages sent by that sponsor. | ||
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| + | [[Category:RPS Glossary]][[Category:RPS Model]] | ||
Latest revision as of 16:04, 23 September 2008
This is a Glossary page
This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized
Contents
R1 Working Definition
An organization 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 regulated products.
For example, a pharmaceutical company.
ICH Equivalent
None
BRIDG Term
RegulatoryApplicationSponsor
An organization 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.
For example, a pharmaceutical company.
Additional Regional Definitions and Synonyms
None
RPS Modeling Discussion
The Sponsor is one of two defined Actors in an RPS message, the other being the Regulatory Authority.
The Sponsor should be identified by a Unique Identifier, either an OID or a UUID. If an OID is used, it may be the root OID for all submissions and data in the RPS messages sent by that sponsor.
