Vault can export submission dossiers for up to 1,000 applications. Bulk export is particularly useful when extracting submissions for product divestiture, product collaboration, and outsourced publishing. Note that you must initiate bulk export from a report.

Unlike the single submission export, bulk export sends dossiers to your Vault’s File Staging Server. From here, you can download it at your convenience.

How to Export

To export submission dossiers in bulk:

  1. Open a report that uses the standard Application Product Country Indication or Submission Application Regulatory Objective report type, or create a new report from one of these types. If these report types aren’t available in your Vault, your Admin may need to activate them.
  2. Optional: You may need to modify the report filters to get the list of applications or submissions you want to export.
  3. Run the report to get the latest results.
  4. From the report viewer Actions menu, choose Export Submissions Archive Applications.
  5. Vault initiates the export.

When the export completes, Vault sends a notification. You can access the file from your Vault’s File Staging Server. Vault automatically deletes export files after 15 days. If your Submissions Archive Export folder already contains more than 1,000GB, you’ll receive a notification to clear your export folder before Vault can export additional submissions.

Limits

A bulk export cannot include more than 1,000 Application records. Otherwise, bulk export functionality does not limit the total number of downloaded files or the total file size.

Report Types

With the Submission Application Regulatory Objective report type, the Submission object is the primary reporting object. This allows you to refine the list of submissions you wish to export based on a submission, application, regulatory objective, or any combination of information on the related objects.

With the Application Product Country Indication report type, the Application object is the primary reporting object. This allows you to refine the list of applications you wish to export based on an application, product, indication, regulatory objective, or any combination of information on the related objects.

How to Access the File Staging Server

See Accessing Your Vault’s File Staging Server.

Export Files & File Formats

You can find all exported content in the Submissions Archive Export folder, within your personal user folder on the Staging Server. The folder structure and folders match those used during submission import.

Your export also includes:

  • Manifest: This file shows a log of all files in the export and information about the documents.
  • Export Summary: This CSV includes a complete list of submissions exported with a relative folder path to the submission folder and field values for the Submission record. (This includes any Submission object fields set to Display in default lists and hovercards.) If your export includes correspondence, the CSV also shows a list of correspondence documents and their metadata.
  • Correspondence: When enabled, the correspondence documents are in Submissions Archive Export, within a folder that matches the document type, subtype, or classification of the material. Vault names each correspondence file using its Document Name value.
  • Failure Log File: This file shows information for each file that failed to export.

Export Job Progress

Admins can monitor the status of the Submissions Archive bulk export job from Admin > Operations > Job Status.

The following permissions control your options for bulk exporting submission archives:

Type Permission Label Controls
User License Type Full User Ability to access the Export Submissions Archive Applications action on a report.
Security Profile Dashboards & Reports: Read Dashboards and Reports Ability to view and run reports. Bulk export is only accessible from reports.
Security Profile Objects: Reports: Read Ability to view and run reports. Bulk export is only accessible from reports.
Security Profile Objects: Reports: Create Ability to create new reports. This access is necessary if another user has not created and shared a report with the Application Product Country Indication report type.
Security Profile RIM Submissions Archive: Bulk Export Ability to access the Export Submissions Archive Applications action on a report; by default, this permission is only granted to users with the standard System Administrator or Vault Owner security profiles.
Security Profile File Staging: Access Ability to access the file server in order to download the exported files.
Object Sharing Settings Viewer (On Submission records and Application records) Ability to view the object records that you will be exporting, if Custom Sharing Rules are enabled for these objects.
Document Role View Document (On archive binder) Ability to access the archive binder.
Document Role Download Source (On documents in the archive) Ability to download the source file for a given document via export.