RIM Submissions Archive allows users to import final submission dossiers for your organization’s records and later review. This article discusses the configuration required to allow users to import submissions in your Vault.

Setting Up Submissions Archive Document Fields

Before users can import submissions, you must complete the following:

  • Associate the Applications (applications__v) document field with the Submissions Archive document type.
  • Associate the following document fields with the Submissions Archive > Content document type:
    • Submissions (submissions__v)
    • Archive Sections (archive_sections__v)
    • Submissions Archive Document Section (submissions_archive_document_section__v)
  • Optional: Contact Veeva Support to have the Submissions Archive Document Section field populated on existing Submissions Archive content in your Vault.

When users import a submission dossier, Vault automatically populates these document fields. You can configure Dynamic Access Control to define more granular rules about submission content. For example, you can configure a custom field, Financial, to group related sections, and create a lookup to the grouping field on the Submissions Archive document type. You can then migrate current Dynamic Access Control rules to leverage the new document lookup field.

Object Configuration

You can enable several submission import options by configuring Vault objects:

  • Enable attachments on the Submission object to allow Vault to add import results as attachments on Submission records. Users can then access import results more easily.
  • Add the Dossier Details lookup field and the Dossier Status field to all Submission object types and page layouts. This allows users to access the related Dossier Details records that Vault creates or updates when users import or re-import submissions.

Duplicate Content Detection

Enable Duplicate Content Detection to allow Vault to reuse existing Submissions Archive documents based on the MD5 checksum value rather than creating duplicate documents. We recommend enabling this option for all RIM Vaults.

Automatic Sequence ID Generation

Enable the Automate the Sequence ID creation checkbox on the Admin > Settings > Application Settings page to allow Vault to automatically calculate and assign a Sequence ID (xml_submission_id__v) when users create a new Submission record.

Submission Import Settings

There are several submission import settings that you can enable or disable from the Admin > Settings > Application Settings page.

Imports with Unreferenced Files

You can allow users to upload files that aren’t referenced in the eCTD XML, for example, European working documents or Swiss submission cover letters. Select the Import files not referenced in the eCTD XML checkbox to allow submission imports with unreferenced files.

Bulk Submission Imports

From a list of Submission records, users can start a bulk action to import a single dossier to multiple submissions. Select the Enable Submission dossier import through Bulk Action checkbox to allow bulk submission import in your Vault.

Enable Submission Imports with Invalid XMLs

By default, Vault prevents users from importing submissions with invalid XMLs through the Vault UI. To allow users to import submissions with invalid XMLs, set the Allow imports to proceed with invalid XML checkbox. When a submission XML is invalid, Vault will display a warning but won’t block the submission import.

Enable Submission Level ZIP Imports

By default, Vault prevents users from importing ZIP files located inside the submission folder. When the Process Zip imports at the Submission level checkbox is set, Vault processes all ZIP file uploads as if the file contents were created at the submission level of the application, and files at the root of the ZIP become attachments of the submission. If attachments are not enabled, Vault places the files at the root of the Submissions Archive Viewer.

Submissions Archive Viewer Settings

There are several settings for the Submissions Archive Viewer that you can enable or disable from the Admin > Settings > Application Settings page.

Correspondence Documents

You can allow users to view correspondence documents tied to applications and submissions in the Submissions Archive Viewer. See Enabling Correspondence Documents in Submissions Archive for detailed instructions.

Empty Section Indication

Setting the Enable identifying empty sections in the viewer checkbox allows Vault to calculate and apply a visual styling in the viewer, indicating which sections in a submission do not contain documents. Once enabled, this setting cannot be disabled.

See Submissions Archive Empty Section Indicator for additional setting and job behavior considerations.

Configuring Submission Reimport

Users may need to replace a submission dossier that was imported previously, for example, when a leaf operation is incorrect or a file needs to be replaced prior to finalizing the dossier. Complete the following step to allow users to remove the previous dossier and import a new one in a single step:

  1. Navigate to Admin > Configuration > Objects > Submissions > Actions and set the Reimport action to Active.
  2. Add the Reimport action to all object types for the Submission object.
  3. Update any custom permission sets to include the Reimport object action permissions.
  4. Optional: Configure Atomic Security on Submission lifecycle states to define the states in which users can access the Reimport action.

Configuring Submission Import with Vault File Manager

You can set up your Vault to allow users to import submission content using Vault File Manager for Windows™️. See Configuring Submission Import with Vault File Manager for detailed instructions.

Configuring Submissions Archive Jobs

RIM Submissions Archive includes several jobs to help manage submission documents in your Vault. Navigate to Admin > Operations > Job Definitions to activate and schedule these jobs.

Auto-Delete for Orphaned Submission Documents

Submission documents can become orphaned when a user imports them as part of a Submissions Archive dossier, then removes the submission structure. Vault can automatically delete these documents as a daily batch job to prevent users from referencing them. You can enable auto-delete by making the Submissions Archive Delete Orphaned Files standard job active.

Submissions Archive Harmonization

RIM Submissions Archive includes the Submission Archive Harmonization job to correct leaf lifecycle operations. Schedule this job to enable Vault to correct instances when submissions have broken references.

In addition to the scheduled daily job, another type of Submissions Archive Harmonization job runs automatically at the end of a Submission import, removal, or reimport if the queue is empty. This job instance corrects the eCTD submission placeholder files Vault creates when processing bulk imports asynchronously.

Submissions Archive Empty Section Indicator

When the related Submissions Archive application setting is enabled, Vault calculates the content of all existing imports by immediately activating, scheduling, and queueing the Submissions Archive Empty Section Indicator job.

Subsequent calculations (job runs) are processed via Vault Java SDK record triggers:

  • From Submissions Archive, as submissions are imported or removed.
  • From Submissions Publishing, when an on-demand or continuous publishing event creates, updates, or deletes nodes. These events include when publishing is set to Inactive on a US Grouped Submission and the system replicates the US Grouped Submission to each of the target applications.

Vault schedules the Submissions Archive Empty Section Indicator job to run five (5) minutes after these events to allow their associated jobs to complete.

Configuring Atomic Security for RIM Actions

With Atomic Security, you can secure RIM standard actions within an object lifecycle based on the state of the record and the user’s assigned role. Atomic Security is available for most actions in Submissions Archive Vaults. However, certain actions on the Submissions object are only available in the following conditions:

  • When Submissions Archive Status and Dossier Status fields are empty or null, the Import action is available.
  • When Submissions Archive Status and Dossier Status fields have a value of Import in Queue or Import in Progress, the Cancel Import action is available.
  • When Submissions Archive Status and Dossier Status fields have a value of Import Successful, the Remove Submission action is available.
  • When Submissions Archive Status and Dossier Status fields have a value of Removal in Queue or Removal in Progress, the Cancel Removal action is available.

Vault logs all Submissions Archive actions in the audit trail.