Adding and Managing Documents

Adding and Managing Documents #

Placing documents into the eCTD Table of Contents is the core activity in DnXT Publisher. Whether you are uploading files from your local computer, dragging documents from a cloud storage provider, or browsing an FTP share, Publisher provides multiple pathways to get your documents into the right place in the submission structure. This guide covers every method for adding documents, managing file placement, and working with the Content Manager.

Document Placement Overview #

In eCTD publishing, “placing” a document means associating a file with a specific node in the Table of Contents tree. When you place a document at a TOC node, Publisher records the document’s title, filename, file path, and format as part of the eCTD backbone XML. The physical file is stored in Publisher’s content repository, and the TOC tree is updated to show the document at that node.

Documents can be placed through several methods:

• Drag and Drop — Drag files from the Content Manager directly onto TOC nodes.
• Upload from Local Computer — Use the upload dialog to select files from your local file system.
• Content Manager Browse — Navigate files in FTP, Box, or Egnyte and select them for placement.

Using Drag and Drop #

The drag-and-drop method is the most intuitive way to place documents. Here is the step-by-step process:

1. Open a dossier in the TOC Editor by double-clicking it in the Dossier Library.
2. In the right panel, open the Content Manager by clicking the Content Manager toggle button.
3. Navigate to the file you want to place by browsing the folder structure in the FTP Share, Box, or Egnyte tab.
4. Click and hold the file you want to place.
5. Drag it from the Content Manager onto the target TOC node in the left panel.
6. Release the mouse button to drop the file onto the node.
7. A placement confirmation dialog will appear, showing the document title, filename, and the target node. Confirm or edit the details, then click Place.

Content Manager #

The Content Manager is a panel within the right side of the TOC Editor that provides access to three external file source integrations. It enables you to browse, search, and select files for placement without leaving Publisher.

FTP Share Tab #

The FTP Share tab connects to your organization’s FTP or SFTP server. You can browse the server’s folder structure, navigate into subdirectories, and select files for drag-and-drop placement or direct placement. This is commonly used when documents are stored on a shared network drive that is exposed via FTP.

Box Tab #

The Box tab integrates with Box cloud storage. After your administrator has configured the Box connection, you can browse your Box folders, navigate through the folder hierarchy, and select files for placement. Box integration supports all file types supported by Publisher.

Egnyte Tab #

The Egnyte tab integrates with Egnyte cloud storage, providing the same browsing and file selection experience as the Box tab. Navigate through Egnyte folders and select files for placement in the TOC.

Uploading Files from Your Local Computer #

If your documents are on your local machine rather than a cloud or FTP source, you can upload them directly:

1. Select the target TOC node in the tree.
2. In the right panel Node Details view, click the Upload or Browse button.
3. A file selection dialog opens. Navigate to the file on your local computer.
4. Select the file and click Open.
5. The file is uploaded to Publisher’s content repository and associated with the selected TOC node.
6. Confirm the document title, filename, and other metadata in the placement dialog.

Document Placement Details #

When placing a document at a TOC node, you can configure the following fields:

Supported File Formats #

Publisher supports all file formats specified by the eCTD standard, including:

• PDF — The primary format for most eCTD documents. Publisher supports PDF/A for long-term archiving.
• XML — Used for structured data files, regional XML forms, and the eCTD backbone itself.
• JPEG/JPG — Image files for figures, diagrams, and photographs.
• PNG — Image files with transparency support.
• SVG — Scalable vector graphics.
• TIFF — High-resolution image files.
• XPT — SAS transport files for clinical study data (CDISC datasets).
• SAS — SAS program and data files.
• STF — Study Tagging Files for clinical studies.

Managing Placed Documents #

After a document has been placed at a TOC node, you can manage it through the right panel:

Viewing a Placed Document #

Click on a TOC node with a placed document, then switch to the Document Viewer in the right panel. The document will render in an in-browser viewer. PDF files show a full preview with page navigation. XML files show formatted content.

Editing Document Metadata #

Select the TOC node and view its Node Details in the right panel. You can edit the document title, filename, and other metadata fields. Changes are saved when you confirm the edits.

Replacing a Document #

To replace a document with a newer version, use the Replace lifecycle operation. This is covered in detail in Document Lifecycle and Status.

Removing a Document #

To remove a document from a TOC node, select the node and use the delete or remove option in the Node Details panel. Note that removing a document in a subsequent submission creates a “delete” lifecycle operation rather than physically removing the file.

Multi-Document Tabs #

The Document Viewer in the right panel supports tabbed viewing. When you click on multiple TOC nodes in sequence, each document opens in a new tab. You can switch between tabs to compare documents, and you can close individual tabs when you no longer need them. This is particularly useful when reviewing related documents across different sections of the TOC.

Best Practices for Document Management #

• Use descriptive titles — Document titles appear in the eCTD backbone and are visible to health authority reviewers. Use clear, descriptive titles that accurately reflect the document’s content.
• Follow naming conventions — Many organizations have naming conventions for eCTD filenames. Follow your organization’s conventions for consistency.
• Check file sizes — Some health authorities have file size limits for individual documents. Very large PDF files may need to be split into parts.
• Use PDF/A format — When possible, use PDF/A format for long-term archivability and compliance with health authority expectations.
• Verify document content — Use the Document Viewer to verify that the correct document has been placed at each node before validation and publishing.

Frequently Asked Questions #

Can I place the same document at multiple TOC nodes? #

Yes. The same physical file can be referenced by multiple TOC nodes. Publisher manages the file storage efficiently so that the file is not duplicated.

What happens if I place a document at a node that already has one? #

If the node already has a document, you will be prompted to specify the lifecycle operation — typically Replace or Append. See Document Lifecycle and Status for details.

Can I drag and drop files from my desktop? #

Direct drag-and-drop from the operating system desktop into the browser is supported in some browsers. However, for the most reliable experience, use the Content Manager panel or the Upload dialog.

What is the maximum file size for uploads? #

The maximum file size depends on your organization’s server configuration. Contact your administrator if you encounter upload size limitations.

Can I bulk-place documents across multiple TOC nodes? #

Publisher supports placing multiple files in a single drag-and-drop operation to one TOC node. For placing files across multiple nodes, you will need to repeat the placement operation for each target node.

Related Articles #

• Submission Authoring with the TOC Editor — Navigate the TOC Editor workspace.
• Document Lifecycle and Status — Manage New, Append, Replace, and Delete lifecycle operations.
• Creating and Managing Hyperlinks — Add cross-references between documents.
• Validating and Publishing — Validate document placements and publish.
• Global Search — Find documents across all dossiers.