Required Roles: eCTD Editor (to import archives); eCTD Manager (to manage the archive browser)
Overview
Kivo's eCTD Viewer allows you to import eCTD-format zip archives that have been stored as document versions in the DMS. Imported archives are organized under an Application within the eCTD Viewer's Category > Product > Application hierarchy, and can be viewed individually or in cumulative or current sequence views.
Archives can be imported one at a time from a document's version history, or in bulk using the DMS bulk actions. Both methods require the source document version to be a zip file.
Before You Start
Before importing, confirm the following:
The document version you want to import is saved as a zip file. Non-zip versions are not eligible for eCTD import.
A Product and Application already exist in the eCTD Viewer for this submission. If not, see Creating and Managing Categories and Products to set them up first.
You have eCTD Editor permissions. If you do not see the import option on a document version, contact your Workspace Manager.
Importing a Single Archive from a Document Version
Navigate to the archive document in the DMS and open its Version History.
Locate the version you want to import and select the actions menu (three-dot or row actions) for that version.
Select Import to eCTD Viewer. The import modal opens, pre-populated with the last-used product if available.
Select the Submission Format:
eCTD -- standard electronic Common Technical Document format.
NeeS -- Non-eCTD Electronic Submission format.
Folder Structure -- a non-sequenced archive; you will be prompted to enter a sequence number instead of mapping to a submission.
If your organization has multiple categories, select the appropriate Category.
Select the Product this archive belongs to.
Select the Application under that product. Only applications belonging to the selected product appear in the list.
(Optional) Select a Submission to link the archive to an existing submission sequence. When a submission is selected, Kivo will attempt to automatically map sections and files in the archive to the submission's folder structure.
Note: The Submission field is not shown for Folder Structure imports. Instead, enter the Sequence Number that should identify this submission in the eCTD Viewer.
Finally, select Import to begin. A success toast confirms the import has started. Kivo processes the archive in the background; its status in the eCTD Viewer will show as processing until complete.
Importing Multiple Archives via Bulk Action
If you have multiple arhives to import at once, please reach out to support with the following information:
Folder location of the archives
The specific selection of archives that should be imported
The Product, Category, and Application the Archives should be imported to.
After Importing: Viewing and Managing Archives
Once an import is complete, the archive appears in the eCTD Viewer under the Application you selected. Each archive displays its name, status, and creation date.
Archive statuses include:
Ready -- the import completed successfully. Select Open to view the archive's document tree.
Error -- the import encountered a validation or structural problem. Select the error indicator to see details. See eCTD Viewer Errors: Understanding Validation Errors and How to Resolve Them for guidance.
From the Application view, you can also access:
Cumulative View -- shows all sequences in the application combined.
Current View -- shows only the latest sequence across all archives.
To delete an archive, select the trash icon next to it. To add or update the archive description, open the archive and edit the description field directly.