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CTD Module 1

3 August 2020

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1.1 Comprehensive table of contents

Overview

All dossiers in NeeS format must include a comprehensive table of contents for the complete dossier.

Summary of requirements

Documentation
Section Description Category 1/COR report-based Variations to quality only (e.g. Category 3)
New registration Variation New registration Variation
1.1 Comprehensive table of contents (for dossiers not in the eCTD format) mandatory mandatory mandatory mandatory

When to include a comprehensive table of contents

Include a comprehensive table of contents in all dossiers in NeeS format.

How to prepare a comprehensive table of contents

The comprehensive table of contents is a complete list of all documents in the dossier, arranged by Module, and with location references for each document.

Specify the titles of studies in the table of contents, indicating the type of study and topic in the title. Study codes alone are not acceptable.

Location reference

All documents in a NeeS dossier should be referenced from a hyperlinked table of contents. Hyperlinks for each document should always be provided to the first page of the appropriate file.

Do not use page numbers for document location as page numbering is at the document level only.

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