Difference between revisions of "Context of Use (RPS)"

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==Additional Regional Definitions and Synonyms==
 
==Additional Regional Definitions and Synonyms==
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Table of Contents Section
  
 
[[Category:RPS Glossary]]
 
[[Category:RPS Glossary]]

Revision as of 22:33, 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

An element of the RPS model, which contains a reference to a single File, a coded value indicating the portion of the Dossier that the file is related to, and optionally one or more [[Keyword (RPS)|Keyword]s that further identify the file. A Context of Use may also refer to a previous Context of Use that it replaces, permitting a file to be rearranged within a Dossier.

Multiple Context of Use items may refer to the same file if a file is used in more than one place in a Dossier.

ICH Equivalent

CTD Module Element and also STF File Tag

Note that the ICH module elements may contain multiple leaf elements, which correspond more closely to an RPS Context of Use in that they reference a single file and indicate life cycle, but do not in and of themselves identify the section of the dossier.

BRIDG Term

Context of Use

In the BRIDG Model version 101, it is defined as an attribute (typeCode) of a Document:

A code that identifies a general class or category of documents.
For example, amendment, background material, guide, etc.
For example, in RPS, this is the code that specifies how the file is to be used within the submission process (e.g. Protocol, Summary Introduction).
For example, a RegulatoryRecord - A document that meets a record requirement of a regulatory authority and must be retained in accordance with that agency's records retention requirements. Example: Data.

Note, please that this definition is based on a pre-release 1 RPS model, with a separate Document element.

Additional Regional Definitions and Synonyms

Table of Contents Section