(Note: This post is part of a multi-part series on the CTD this fall)

It appears to me that the explanations on the eCTD program page are targeted towards those who build XML publishing tools rather than users. That’s one reason why the structure and process seems so complicated. Review of some of the vendor tools web sites helped me clarify the process flow to:

1. Create the backbone document with the appropriate sections from the CTD.
2. Assign the individual data files to the different sections of the backbone document.
3. Format each document appropriately according to it’s type. PDF files in particular need hyperlinks, bookmarks, and headers/footers to enable cross-references to other parts of the submission.
4. Add appropriate metadata for particular sections. For example, data submitted in sections 4 or 5 requires study tagging files to group information related to individual clinical studies.

Once assembled, most tools will let you validate the submission against at least one of the regional implementations of the eCTD and then package the submission for electronic transmission. You can think of the publishing tool as an interface that enables the user to write the document without needing to understand the underlying XML code. Search for ‘eCTD publishing tools’ online to find out more about your options.

Reach out to me if you want to know more or discuss your medical product development challenges.

katrina@krogersconsulting.com

linkedin.com/in/katrinarogers

https://calendly.com/katrinarogers

Text Copyright © 2019 Katrina Rogers

Follow the links below to read each part of the series.

Electronic Regulatory Submissions Part 1

Electronic Regulatory Submissions Part 2

Electronic Regulatory Submissions Part 3

Electronic Regulatory Submissions Part 4

Electronic Regulatory Submissions Part 5

Electronic Regulatory Submissions Part 6

Electronic Regulatory Submissions Part 7

Electronic Regulatory Submissions Part 8

Electronic Regulatory Submissions Part 9

Electronic Regulatory Submissions Part 10

Electronic Regulatory Submissions Part 11

Electronic Regulatory Submissions Part 12

Electronic Regulatory Submissions Part 13

Electronic Regulatory Submissions Part 15

Electronic Regulatory Submissions Part 16