Import a Submission

Who can complete this task? Veeva RIM Basics: Vault Admin, RIM Admin, Submission Manager

If your submission is smaller than 4 GB, you can import it to the Submissions Archive directly from the file’s local storage location. If your submission is larger than 4 GB, you must first upload it to Vault’s file staging server using an FTP client.

Note Prior to importing a submission, you must create the corresponding Application and Submission and the submission needs to be at least In Progress.

Complete the following steps to import a submission smaller than 4 GB to the Submissions Archive:

  1. Navigate to the Submission Mgmt > Submissions tab and open the submission you want to import.
  2. From the All Actions menu, select Import.
  3. In the Submissions Archive Import dialog, choose your submission ZIP file using one of the following methods:
    • Click Choose and select the ZIP file that contains the submission you submitted to the Health Authority.
    • If you have previously used an FTP client to import a submission to this Vault, the Upload now and FTP user folder options are displayed. Select Upload now, click Choose, and select the ZIP file that contains the submission you submitted to the Health Authority.
  4. Click Next. Review the information in the dialog to ensure that the folder names and number of files are correct and as expected.
  5. Click Import. A message is displayed to indicate that the import is in progress, and Vault changes the submission’s Dossier Status to Import In Progress.
  6. After you receive a notification in the Notifications panel that the import process is complete, click Refresh to refresh your browser.
  7. To view details about the import results, click the Submissions Archive Import Results file in the Attachments section of the submission to open the results file.

Best Practice for Importing eCTD Submissions

If your submission contains the Index XML at the root within the first or second folder, it will be imported as an eCTD.

To make sure your eCTD submission imports successfully, refer to this example:

Example
  • Dossier Format on the submission record is set to eCTD
  • Folder Name is set to NDA 123456
  • XML Submission ID is set to 0000
  • Submission contains the Index XML within a single submission folder called 0000.

When you import your submission, the contents of the 0000 folder, including the Index XML and other files, exist within the submission folder path nda123456/0000.