eCTD Software: Publishing Tool

No eCTD submission can be made without software to compile and render documents and to build a valid XML backbone with compliant metadata and file checksums. Lost yet? No worries. At the heart of any eCTD software package is an XML publishing tool designed to make the process as foolproof as possible.

The following is a discussion of what eCTD publishing is and what XML publishing software does. How it does it is beyond the scope of this website and probably most of our imaginations.

What eCTD publishing is...

Though the term is frequently used loosely in the industry, we describe publishing as the final compilation of regulatory documents in eCTD submission format. This typically includes:

• Assignment of documents to a location within the eCTD modular structure
• PDF rendering of final, hyperlinked documents
• Customization of document headers/footers
• Assigning eCTD titles and grouping study-related files
• Setup of submission-specific values (e.g., application and sequence number)

What eCTD publishing software does...

Perhaps the most complicated part of eCTD software packages, the eCTD publisher application has a lot of responsibilities. Luckily for us, most of the complicated tasks are performed automatically.

Publishing regulatory-compliant submissions requires familiarity with many regulations and ICH guidances, and would be very difficult without proper eCTD training or the assistance of an experienced eCTD consultant. A good software provider will demonstrate how to use their publishing tool and even provide an introduction to the regulatory specifications.

As an example of the process, an outline of eCTD publishing is provided below.

• Sponsor- and submission-specific information is entered into the publisher. These are examples of the metadata that will be built into the XML backbone. The publishing tool will typically guide the user to complete the required information.
• Submission documents are assigned to a specific location within one of the eCTD modules and eCTD titles are added. This is usually done manually by dragging source documents from a file explorer window and dropping them into their correct location within the eCTD structure. Each submission document is then assigned a title using established file-naming conventions.
• Documents are rendered. Rendering refers to the automatic conversion of documents to submission-ready PDFs, managing hyperlinks, bookmarks, and document headers/footers in the process.
• Additional submission metadata are added. For example, Study Tagging Files (STFs) are required for any eCTD submission containing information in modules 4 or 5. Put simply, STFs group all information related to a particular study
• eCTD Submission validation is performed. The eCTD publishing application will perform a thorough analysis of the submission to ensure the production of a valid XML backbone and to examine certain elements of the submission to ensure regulatory compliance.
• An .xml index file is created. With the click of a mouse, the program will produce an XML backbone specific to the submission.

During the process, the eCTD publisher will automatically adjust all hyperlinks and bookmarks so that they remain intact within the submission and with the eCTD lifecycle (i.e, with previous submissions). The output folder for the submission is what is submitted to the regulatory agencies (e.g., FDA, EMEA, etc.).