Professional Documents
Culture Documents
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Overview
• Background Information
• eCTD Guidance and Specifications
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Background
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Submit in eCTD Format
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Definitions
Harmonisation
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Getting Started
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Use All Available Reference Material
• CTD Guidances
– International Conference on Harmonisation - Joint Safety/Efficacy
(Multidisciplinary)
• eCTD Guidances
• Specification Documents
– Module 1 Regional
– Module 2 through 5
– Study Tagging File
– Study Data Specifications
– PDF Specifications
• Very Import to Read This
– eCTD Table of Contents
– Heading and Hierarchy Document
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eCTD Guidance
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eCTD Specifications
• eCTD Specifications
– FDA Module 1 Specification
– FDA Modules 2 to 5 Specification
– Study Tagging File Specification
• FDA eCTD Table of Contents Headings
and Hierarchy
• Documentation Available On-Line
http://www.fda.gov/cder/regulatory/ersr/default.htm
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NOT Part of
The CTD Triangle
Regional the CTD
Admin
Information
Module 1
Module 2
Nonclinical Clinical
Overview Overview The CTD
2.4 2.5
Quality
Overall Nonclinical Clinical
Summary Summary Summary
2.3 2.6 2.7
Nonclinical Clinical
Quality Study Reports Study Reports
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Many Have Used a Contractor
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Do I Need Reviewer Approval?
• No!
• Communication of your intent very
helpful though
– Helps with training
– Helps alleviate any anxiety
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eCTD Changes
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An index.xml file
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FDA Reviewer View of an eCTD
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eCTD Changes
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Understand the eCTD Lifecycle
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Lifecycle Operators
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Lifecycle Operators contd.
• Operation Attribute
• New
• Referenced file is being used in a new context
• Append
• Referenced file is being used to add
information
• Append only files introduced as New or
Replace
• Replace
• Referenced file is being used to replace a
previous file
• Delete
• Used to signal that a previously submitted leaf
is no longer to be considered relevant to the
review
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Lifecycle Operators contd.
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What doesn’t change
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eCTD Sample Process
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What to Include in a Sample
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What to Include in a Sample cont.
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Submissions 101
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All eCTD Submissions Include Module 1
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No Duplicate Submissions of mixed
paper/electronic applications
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No Electronic Desk Copies
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Everything you Submit is “Official”
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All PDF HyperLinks & Bookmarks are
Correct
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Provide Bookmarks
• Good • Bad
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We are seeing more and more fundamental
errors
• Duplicate submissions
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Please Remember…
– 909 is bad
– 0909 is good
• Your sequence number must be unique
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Just say no…
• No paper
• No Word files or file formats not
specified in the guidance
• No electronic submissions or records
sent directly to a reviewer or project
manager
• No electronic desk copies
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Just do it…
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Remember….
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References
• CDER Contact for information on eCTD submissions
esub@fda.hhs.gov
• CDER Contact for information on SDTM submissions
cder-edata@fda.hhs.gov
• Electronic Regulatory Submissions and Review
website
http://www.fda.gov/cder/regulatory/ersr/default.htm
• International Conference on Harmonization
http://www.ich.org
• All FDA Guidances on Electronic Submissions
http://www.fda.gov/cder/guidance/index.htm#electronic_submissions
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