This section provides some general background and a Summary of Key Points for using Publish.
Views
An application/submission can be modified in 3 views; Origin, Lifecycle, and Current.
Lifecycle and Current views are referred to as modular views as they display the eCTD application’s modules only. These views are helpful when looking at the application in its entirety and for lifecycling documents throughout the applications.
Origin view is a sequential view and is most frequently used when compiling submission specific documents. The initial view is broken down by submission unit initially and subsequently by module.
Applications
In eCTD terms, an application is “A collection of documents compiled by a pharmaceutical company or its agent in compliance with… legislation and guidelines in order to seek a marketing authorization or any amendments thereof.” (Ref. 7) An application is also sometimes called a dossier.
An application always has a unique number.
Submission Units
A submission unit is “a single set of information and/or documents supplied by the
applicant as a part of, or the complete, Application.” (Ref. 7) A submission unit will
always have a four digit submission unit number. An application initially consists of a single submission unit (the original application) and over time may grow to include dozens or even hundreds of submission units. A submission unit is sometimes referred to as a “submission”, but this is a somewhat ambiguous term as in some markets a submission is equivalent to an application.
Regulatory Activities
Submission units are organized into regulatory activities. A regulatory activity is “a collection of submission units covering the start to the end of a specific business process, e.g., an initial MA application or Type II variation.” (Ref. 7) In the US, it is used to organize documentation related to an original application or supplement into a single unit for review and approval.
GlobalSubmit Publish is used to create and maintain eCTD applications including:
Adding, editing, and maintaining submission units
Organizing submission units into regulatory activities
Files
Files are the actual documents and data files sent to a regulatory agency for review. Initially, they are located in a locally hosted document repository. As the submission is being built, Publish transfers the files to an organized publishing location and places them in a folder structure, per regional and ICH guidance. These physical documents are considered files throughout this guide.
Note: File names are automatically renamed to meet with regulatory agency requirements (all lower-case letters, dashes instead of spaces, expected naming conventions for certain sections, etc.) during the upload process.
File References
Agency reviewers of applications rarely work with the source files directly. Instead, they view the contents of the application via the Table of Contents (TOC). The table of contents contains file references, which point back to, or reference, the files on the file system.
The file reference has a more descriptive title, allowing the reviewer to see each file in a friendlier manner. For example, a file named nomenclature.pdf might appear in the TOC with the title of “Nomenclature of Reox.”
Architecture and File Transfer
When using Publish:
source files are copied from a document repository or staging area to the publishing area (and added to the TOC). Thus source files are preserved;
the copies are organized into a compliant folder structure and renamed as required by the health authorities;
intra-document (external) hyperlinks are added as needed;
XML structural and supporting elements are added (e.g., XML backbones, Study Tagging Files, DTDs and style sheets, checksum, etc.).
The file transfer and other associated activities occur when you save your work in Publish. Before that time, any additions or changes you make are only visible to you. When work is saved, files are transferred in the background. This allows a user to continue working without waiting for file transfer to complete.
Creation of the XML structure and supporting elements occurs once the submission unit is published. See the “Publish a submission unit” section for additional details about publishing.
Summary of Key Points
To edit the structure or content of any portion of a submission unit, the user account must have permission to perform publishing activities.
Your changes are local to you until you save your work. At that point, the central Publish database is updated and changes become visible to other users of Publish and Review. File transfer continues even if you close Publish as long as your workstation remains connected to your network.
After changes have been saved, your reviewers can review and comment on a submission unit using GlobalSubmit Review.
The XML elements of a submission unit are created when the submission unit is published. At this point, it is ready for final validation and submission to a regulatory agency.