Organizing the Submission Dossier Structure

You can organize the volume and file structure of the Submission Dossier before you publish it as an eCopy of the submission.

Required access roles: Regulatory Lead of submission project owner

Note: The eCopy publishing options are available only when the submission's publishing file format is set to eCopy on the Regulatory Information tab. See Editing Properties for Submission Master Records.

Before you begin: Open the submission project. See Opening a Submission.
Tip: Determine whether you want to use volumes before you reorganize any files within the Submission Dossier structure. Changing the With Volumes/Without Volumes setting will change the Submission Dossier structure and may negate the changes you have made to file order.
See Also
About eCopy Submissions
eCopy Page
Publishing the Submission Dossier
  1. In the navigation pane, click Publishing.

    Tip: You can click Reset at any time while you are organizing the Submission Dossier structure to return it to the default structure. Any changes you have made will be undone. You cannot restore any changes you made to the structure after you have reset it.

  2. In the eCopy tab, indicate whether you want to include volumes in the published Submission Dossier structure.
    • If you want to publish the Submission Dossier without using volumes in the structure:
      1. Click Without Volumes .
      2. Click OK to confirm that you want to remove the volumes from the Submission Dossier structure.

      The Submission Dossier structure is flattened to show only autonumbered file names, in the order in which they appear in the Submission Dossier folders list (which is listed by document name, not file name), without the controlled folders (volumes) that contained them. The autonumbers assigned to the files in the flattened structure are updated to reflect the files' new sequential order in the Submission Dossier structure (without intervening volume numbers to reset the autonumbers).

    • If you want to restore the volumes to the Submission Dossier structure:
      1. Click With Volumes .
      2. Click OK to confirm that you want to restore the volumes to the Submission Dossier structure.

      The volumes are restored to the Submission Dossier structure. The autonumbered volume names are updated to reflect their sequential order in the structure, which is the order in which they appear in the Submission Dossier folders list (listed alphabetically by controlled folder name). The autonumbers assigned to file names are updated based on their sequential order within each volume.

  3. Indicate which volumes and files you want to include in the Submission Dossier structure when it is published in eCopy format.
    • If you want to remove a volume and its contents or an individual file from the Submission Dossier structure:
      1. Select the volume or individual file that you want to exclude from the published submission.
      2. Click Remove or Undo Remove .

      The name of the selected volume and all of its files or the selected individual file is struck through in red, indicating that it will not be included in the published eCopy of the submission.

    • If you want to restore a removed volume and its contents or an individual file to the Submission Dossier structure:
      1. Select the removed volume or individual file that you want to include in the published submission.
      2. Click Remove or Undo Remove .

      The name of the selected volume and all of its files or the selected individual file changes back to normal text, indicating that it will be included in the published eCopy of the submission.

  4. Organize the Submission Dossier's volumes or the flattened file structure without volumes in the order in which you want them to be included in the published eCopy of the submission.
    • If you want to move a volume and its contents or an individual file up one place in the Submission Dossier structure:
      1. Select the volume or individual file.
      2. Click Move Up .

      The selected volume or file moves one place up in the Submission Dossier structure.

    • If you want to move a volume and its contents or an individual file down one place in the Submission Dossier structure:
      1. Select the volume or individual file.
      2. Click Move Down .

      The selected volume or file moves one place down in the Submission Dossier structure.

Your Submission Dossier structure reflects the volume and file organization that will be used when the eCopy of the submission is published.