Keyword (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

A Keyword is a piece of metadata or identifying information associated with a File through a reference in a Context of Use. The Keyword Definition element belongs to the Application (Dossier). Keywords may be elements of controlled lists (such as Species, Route of Administration), or free-form text (such as Study ID).

For example, a New Drug Approval Dossier may include many study report Documents with the same Context of Use code for each Study Report Body File. The Keywords may identify the Study ID, the Indication, etc.

The choice of Keywords associated with each Context of Use is determined by the regulatory authority's requirements for each Regulatory Activity.

Note: there are currently discussions as to whether report components should all share the same Context of Use but different Keywords, similar to the ICH STF File Tag, or whether they should have separate Context of Use codes.

ICH Equivalent

STF File Tag, plus additional metadata associated with certain CTD modules, such as Product, Excipient, Indication, Species, etc.

BRIDG Term

This section is incomplete

Additional Regional Definitions and Synonyms

None

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