Overview #
This glossary defines the key terms and concepts used throughout the DnXT Suite. Whether you’re new to regulatory affairs or new to DnXT, this reference will help you understand the terminology you’ll encounter in the application.
eCTD and Regulatory Terms #
eCTD (Electronic Common Technical Document) #
The internationally standardized format for submitting regulatory applications to health authorities. eCTD organizes documents into a structured hierarchy of modules and sections, making it easier for agencies to review submissions across regions.
CTD (Common Technical Document) #
The content framework that eCTD is based on. CTD defines the five modules of a regulatory submission: Module 1 (Administrative), Module 2 (Summaries), Module 3 (Quality), Module 4 (Nonclinical), and Module 5 (Clinical).
Module #
One of the five top-level sections in an eCTD submission. Each module contains specific types of regulatory information:
| Module | Name | Contents |
|---|---|---|
| Module 1 | Administrative & Prescribing Information | Region-specific forms, cover letters, labeling (varies by region) |
| Module 2 | CTD Summaries | Overviews and summaries of quality, nonclinical, and clinical data |
| Module 3 | Quality | Drug substance and drug product manufacturing, controls, and stability |
| Module 4 | Nonclinical Study Reports | Pharmacology, pharmacokinetics, and toxicology studies |
| Module 5 | Clinical Study Reports | Clinical trial protocols, results, and statistical analyses |
Submission Sequence #
A numbered version of a submission within a dossier (e.g., Sequence 0000 for the initial application, Sequence 0001 for the first amendment). Each sequence can add, replace, append, or delete documents from the cumulative dossier.
Lifecycle Operation #
An eCTD action applied to a document leaf within a submission sequence:
- New — A document being submitted for the first time
- Append — Additional content being added to an existing document node
- Replace — A new version of a document replacing a previously submitted one
- Delete — Removing a previously submitted document from the active dossier
STF (Study Tagging File) #
An XML file used in eCTD submissions to provide metadata tags for nonclinical and clinical study reports in Modules 4 and 5. STFs help reviewers identify and categorize study types.
Leaf #
A single document placed at a specific position in the eCTD TOC tree. Each leaf has properties including title, lifecycle operation, checksum, and file reference.
Health Authority / Regulatory Agency #
The government body that reviews and approves regulatory submissions. Examples include the FDA (US), EMA (EU), Health Canada, PMDA (Japan), and TGA (Australia).
Application Type #
The regulatory pathway for a submission, such as NDA (New Drug Application), ANDA (Abbreviated NDA), BLA (Biologics License Application), IND (Investigational New Drug), or MAA (Marketing Authorization Application).
DnXT Application Terms #
Dossier #
In DnXT, a dossier is the top-level container that groups all submissions for a single product-region-application combination. For example, “ProductX-US-NDA” would be one dossier containing all related submission sequences.
Dossier Plan #
A saved configuration that defines a dossier’s metadata — product name, region, application type, format — before any submissions are authored. Dossier plans can be created from scratch or from templates.
Submission Plan #
The plan for a specific submission sequence within a dossier. Contains the sequence number, submission type, and other metadata needed for eCTD packaging.
TOC (Table of Contents) #
The interactive tree structure in DnXT that represents the eCTD module hierarchy. Users navigate, add documents, and manage submission content through the TOC tree.
TOC Editor #
The primary authoring workspace in DnXT Publisher. The left pane shows the TOC tree; the right pane shows document properties, viewer, or upload interface depending on the selected node.
Template #
A reusable dossier structure definition that can be applied when creating new dossiers or submissions. Templates pre-populate the TOC tree with the expected sections and metadata.
Repository #
The back-end file storage system where DnXT stores all uploaded documents and generated eCTD packages. Repositories can be configured to use local storage, shared network drives, or cloud storage like Azure Blob or Egnyte.
Folder (Dossier Library) #
An organizational container in the Dossier Library used to group related dossiers. Folders can be nested and help teams organize dossiers by project, product line, or region.
Sync / Synchronize #
The process of copying dossier data between DnXT Publisher and DnXT Reviewer. This allows submissions authored in Publisher to be reviewed in Reviewer’s specialized analysis environment.
Validation #
The process of checking an eCTD submission for compliance with technical specifications before publishing. DnXT runs automated validation checks for file format, naming conventions, XML structure, and hyperlink integrity.
Publishing #
The final step that packages a validated submission into the official eCTD format ready for delivery to a health authority. Published submissions include the eCTD backbone XML, document files, and any required metadata.
User Interface Terms #
Dashboard #
The home page of each DnXT application showing summary statistics, charts, and quick-access links.
Library #
A browsable, searchable list view of items (dossiers, plans, templates, documents). Libraries support filtering, sorting, and bulk operations.
Workspace #
The main content area of the DnXT interface where you interact with modules, tables, trees, and forms.
Bottom Panel #
A collapsible panel at the bottom of the screen used for secondary information like account settings, search results, and detail views.
Toolbar #
The row of action buttons at the top of a module view (e.g., Create, Delete, Export, Refresh).
Context Menu #
A right-click menu that appears when you right-click on items in tables or tree views. Shows actions relevant to the selected item.
Breadcrumb #
A navigation trail (e.g., Dashboard > Dossier Library > ProductX > Sequence 0001) showing your current location. Click any part of the breadcrumb to navigate back.
