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File (RPS)
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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
A single electronic file included in a Dossier. A file may constitute an entire Document, or be considered a part of a Document.
In RPS R1, each File is an element of the Application (Dossier), and is referred to by the Context of Use.
ICH Equivalent
Leaf
BRIDG Term
This section is currently incomplete
Additional Regional Definitions and Synonyms
None
