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Difference between revisions of "Submission Unit (RPS)"

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m (RPS Submission Unit moved to Submission Unit (RPS): Alphabeticization is kind of useless if everything starts with RPS)
 
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== RPS Submission==
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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''
  
 
==R1 Working Definition==
 
==R1 Working Definition==
The collection of [[RPS Document|documents] provided to the [[RPS Regulatory Authority|regulatory authority]] at one time.  A Filing or Correspondence between parties.
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The collection of [[Document (RPS)|Document]]s provided by the [[Sponsor]] to the [[Regulatory Authority (RPS)|Regulatory Authority]] at one time (although it can also be used for transfers of submission documents between two sponsors, between two authorities, or a contract organization and an sponsor).  A Filing or Correspondence between parties. '''Submission Units''' are components of a [[Submission (RPS)|Submission]], and may be grouped into [[Reviewable Unit (RPS)|Reviewable Unit]]s.
  
 
==ICH Equivalent==
 
==ICH Equivalent==
Sequence
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'''Sequence'''
  
 
==BRIDG Term==
 
==BRIDG Term==
'''Submission Unit''' - The collection of documents provided to the regulatory authority at one time.
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'''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.
  
 
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.
 
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.
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==Additional Regional Definitions and Synonyms==
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===Human Pharmaceuticals===
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====United States====
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The package of information set at any one point in time
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====Japan====
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''no equivalent concept in Japan''
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===Devices===
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====United States====
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*The package of information mailed at any one point in time
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====Europe====
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*The package of information mailed at any one point in time
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====Canada====
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*The package of information mailed at any one point in time
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====Australia====
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*The package of information mailed at any one point in time
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''How does information entered into DEAL relate to the Submission Unit?''
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====Singapore====
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*The package of documents uploaded onto the agency's website.
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====China====
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*The package of information mailed at any one point in time
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[[Category:RPS Glossary]]
 
[[Category:RPS Glossary]]

Latest revision as of 22:30, 10 November 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 by the Sponsor to the Regulatory Authority at one time (although it can also be used for transfers of submission documents between two sponsors, between two authorities, or a contract organization and an sponsor). 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.

Additional Regional Definitions and Synonyms

Human Pharmaceuticals

United States

The package of information set at any one point in time

Japan

no equivalent concept in Japan

Devices

United States

  • The package of information mailed at any one point in time

Europe

  • The package of information mailed at any one point in time

Canada

  • The package of information mailed at any one point in time

Australia

  • The package of information mailed at any one point in time

How does information entered into DEAL relate to the Submission Unit?

Singapore

  • The package of documents uploaded onto the agency's website.

China

  • The package of information mailed at any one point in time