Submission Unit (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

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.