If you need to work on documents associated with a submission, like those for an IRB, ethics committee, or EU CTR, you can use Clinical Application Management in Study Startup. It allows you to track additional document information (for example, review and approval dates, comments) for a particular milestone with Milestone Package Document records.

Enabling Clinical Application Management

To enable Clinical Application Management, an Admin must configure the Seed Package Documents user action.

Seeding Package Documents

The Seed Package Documents user action is available for configuration on Milestone records. This action checks the latest version of each document stamped with that milestone and then checks for any matching Milestone Package Document records. If Vault finds none for that document version, it creates a new Milestone Package Document record.

You can also create these records directly, which is helpful if you need a document for a submission that isn’t normally needed for the milestone.

Milestone Package Document Records

Once you’ve created Milestone Package Document records, you can populate the following field data:

  • Name: This field defaults to the name of the related document
  • Document: This field references a specific version of a document
  • Study Country
  • Study Site
  • Lifecycle State
  • Department
  • Comments: Rich text field for adding and viewing comments
  • Review Date: The date the document was reviewed (in the context of the milestone)

If a different document version is needed, you can change the Document field reference.

Milestone Package Document Export

The Milestone Package Document Export streamlines the export process. It offers a standard action within Milestones, enabling the export of all Complete State documents linked to Milestone Package Documents. When you execute this action, Vault generates a compressed ZIP file containing the viewable rendition and attachments associated with the exported documents. To align with the naming conventions expected by various institutions, Vault automatically renames the Viewable Rendition based on the value specified in the Export Name of the Milestone Package Document.

To enable the feature, add the user action “Export Milestone Package Documents” to appropriate state(s) in the Milestone lifecycle.

Export & Limits Considerations

  • The export cannot exceed 50,000 documents.
  • The ZIP file cannot be more than 5GB in size.
  • The download link will expire 15 days from the action run date.
  • Documents without a viewable rendition will not be exported.
  • If no export name is specified, Document name will be used.

Security Considerations:

For a user to leverage the feature properly, the following security permissions must be enabled:

  • Security profile :
    • Admin : Jobs : Read Permission
    • Application: Documents: Download Rendition Permission
  • Document Role : View Document & View Content Permissions

Requests for Information

Clinical Application Management also includes Request for Information (RFI) records. If additional information is requested from a board or committee, you can document those requests here and manage the collection and review of responses. In addition, you can relate a Request for Information to one or more milestones and one or more Milestone Package Documents.