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Electronic Submissions for Paper People – What Goes in an Electronic Submission?

July 9, 2015 | BJ Witkin, Senior Manager | Regulatory Operations

OK, the FDA has finally given a date for mandatory electronic submissions but you’ve always been a paper person. Where should you even begin? We have a series of posts planned to help you learn what you need to know.

Let’s start with the content of an eCTD electronic submission.

By now you’ve probably seen the eCTD pyramid so I’m going to assume you’re familiar with the modular layout of the CTD. That’s all fine…but what does it really look like when it’s done, and what is it?

What’s in an eCTD submission?

An eCTD submission is made up of the following components:

  • PDF documents
  • Folders
  • XML files
  • Occasionally other types of docs (SPL for labels, SAS transport files for stats, etc.)

Let’s break that down further.

PDF Documents: This is the content you’re really sending for review, eg, the cover letter, forms, protocols, CSRs, nonclinical reports, investigator documents, etc.

FDA has a specification document which describes the required format of the PDFs (bookmarks, hyperlinks, tables of contents, and so on).

Folders: The PDF documents are placed into specific folders. Each of the CTD modules from the triangle diagram represents a folder.

Each folder then has a collection of subfolders to organize the content further (eg, Module 4 [Nonclinical] has subfolders for Pharmacology, Pharmacokinetics, and Toxicology, and further subdivisions within them).

XML Files: XML is a formatting language similar to the one used to create web pages.

In the case of eCTD submissions, XML is used to tell the Viewer tool (more about that in the next post) all the information about the submission—the sponsor, the application, the submission, the sequence number, the drug substance, and everything else!

What does an eCTD submission look like?

So now that you know what goes into a submission (technically speaking), what does it really look like?

Here’s some XML for an initial IND:xml And here’s how the Viewer displays it:view
When everything is put together, it looks something like this:together

Now that you know what goes in the submission, in the next post I’ll talk about the tools you’ll need in order to produce an eCTD submission.

 

Category: Regulatory Operations
Keywords: eCTD, structure, XML

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