Users can view Submission Administrative Information from a single place in Vault to see the complete captured envelope of eCTD metadata information and context for a submission. With the Submission Administrative Information view, you can more quickly manage, review, and approve information, ensuring data accuracy and compliance for published submissions.

Submission Administrative Information also provides a formatted, readable view of envelope information from the Submission Unit XML for ICH eCTD 4.0 submissions. Instead of viewing raw XML, Vault displays submission data in a structured layout that is easier to read and navigate.

Configuring Object Page Layouts

To allow users to view Submission Administrative Information, you must add the Submission Administrative Information section to the Submission Country join object page layout. We also recommend adding this section to the Submission object page layout.

When configured, users can access Submission Administrative Information directly from the Submission record. If a eCTD XML is available, where it is a Regional XML in an ICH eCTD 3.2-based submission, or a Submission Unit XML in an ICH eCTD 4.0-based submission, Vault displays it in a structured, styled format within the section.

About the Update Submission Administrative Information User Action

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 RIM Vaults. However, the Update Submission Administrative Information action is only available when the Dossier Status field is set to Publishing Active or Publishing Inactive.

If a Submission Unit XML is included as part of the submission, users can open and review it from the Submission Administrative Information section. The XML displays in a user-friendly format rather than raw XML.

See Managing Submission Administrative Information for the permissions users need to view and manage Submission Administrative Information.