Difference between revisions of "Submission Unit (RPS)"
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This is a Glossary page | This is a Glossary page | ||
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''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' | ''This page is under discussion and definitions and aligmnent with the BRIDG model have not yet been finalized'' | ||
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==ICH Equivalent== | ==ICH Equivalent== | ||
| − | Sequence | + | '''Sequence''' |
==BRIDG Term== | ==BRIDG Term== | ||
| − | '''Submission Unit''' | + | '''Submission Unit''' |
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| + | The collection of documents provided to the regulatory authority at one time. | ||
NOTE: A submission unit is made up of one to many documents. Properly defined, the submission unit concept enables companies to create new submission units from any combination of new and previously submitted document. | NOTE: A submission unit is made up of one to many documents. Properly defined, the submission unit concept enables companies to create new submission units from any combination of new and previously submitted document. | ||
Revision as of 17:11, 19 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
R1 Working Definition
The collection of documents provided to the regulatory authority at one time. A Filing or Correspondence between parties. Submission Units are components of a submission, and may be grouped into Reviewable Units.
ICH Equivalent
Sequence
BRIDG Term
Submission Unit
The collection of documents provided to the regulatory authority at one time.
NOTE: A submission unit is made up of one to many documents. Properly defined, the submission unit concept enables companies to create new submission units from any combination of new and previously submitted document.
NOTE: In the dynamic aspects of the model, a submission unit is one message that may have a collection of many documents. There are rules for how submission units are evaluated are described in a state diagram, and the receipt date of the submission unit "starts the clock" for the review of the contents of the submission unit.
